Cell Therapy Industry HiLites 2009-07-17

As Late, Late Show host, Craig Ferguson, says..."It's a great day for America. 'Why is it a great day for America,' you ask? Well, let me tell you".

The US House of Representatives has passed what promises to be (if approved by the Senate) the largest single budget increase for the FDA in the agency's history. Now many an economist or financial wizard may argue why this is fiscally irresponsible given America's economic woes but it certainly is promising for the biotech industry which has suffered due to a lack of resources in the Agency overseeing the sector. This lack of resources permeates into almost every interaction with the agency whether it be awaiting new Guidance, submission reviews, staff attrition, etc.

As it happens it is also a great day for the mother country from which America declared its independence because of their dastardly tea-taxing ways. "Oh, why ever it that so?", you might ask with a fake English accent. Well I'lltell you. It's because the UK Office for Life Sciences (OLS) has announced a "Life Sciences Blueprint" that will attempt to capitalise (well, that's how the English spell it) fully on its "leading global position in regenerative medicine". The OLS has announced £18 million funding from the Technology Strategy Board for a Regenerative Medicine programme (again with the English spelling) of investment to support key areas of commercial R&D and the development of R&D partnerships, supported by additional funding of £3.5 million from the Medical Research Council, the Engineering and Physical Sciences Research Council and the Biotechnology and Biological Sciences Research Council.
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I fell in love with this conference, the venue, and the charming city of Leipzig when it was held in 2007. For a unique and international take on the multi-disciplinary world of regenerative medicine, you should consider meeting at the WCRM 29-31 October 2009.

www.wcrm-leipzig.com

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Well I seem to be on a roll with anything related to Wake Forest recently so 'why stop now' I ask myself, without any compelling reply to the negative. This is just a little FYI. The Babcock Demon Incubator (BDI), a new venture incubator at WFU, promises to be a unique new venture incubator opportunity for regenerative medicine startups. The BDI has has fully equipped wet lab space with available equipment including chemical and tissue culture hoods, PCR, Gel systems, HPLC, microscopes, centrifuges, etc. In addition, BDI clients have access to collaborative opportunities at the Wake Forest Institute of Regenerative Medicine and to a wide range of services and specialized equipment. The incubator provides both residential and non-residential client models depending on client needs. All clients have access to office or lab space, can take advantage of business consulting, and access to an extensive services network designed to provide difficult-to-obtain resources to help young companies succeed. For more information, visit the BDI web site.

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As regular readers of my Industry HiLites will know, from time-to-time I occasionally profile a company here in the front-end of the post providing some background, analysis, and recent developments. I'll formalize this a little by calling it a COMPANY PROFILE but won't promise to include one every time.

On another house-keeping matter you will note that I've changed the section title "FINANCIAL" to "FINANCIAL and DEALS".

COMPANY PROFILE

Bioheart, Inc., (OTC Bulletin Board: BHRT) has announced that they will proceed to the final phase of their clinical trial with muscle stem cells for treatment of cardiovascular disease.

The company convened a panel of experts to review pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (involving nearly 400 patients). Bioheart’s latest Phase II/III MARVEL study has undergone interim analysis. While the data has not been disclosed pending publication confidentiality, this panel of experts was reportedly asked to also review this data.

The panel is reported to have "unanimously and enthusiastically endorsed moving forward" to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure with the goal of bringing the product to market with FDA approval and CMS reimbursement.

It's not entirely clear to me how or why this panel of experts was called together but a listen of the audio of the panel discussion frankly makes it sound a little bit like a love-in for Bioheart. In the accompanying slide deck, you will find an overview by Chairman and CEO, Howard J. Leonhardt listing an extremely aggressive list of deliverables for 2009 for a dizzying array of clinical products & programs.

On the financial front, Leonhardt states the company has to-date invested $125 million to support heart failure-related research - $85 million of which was in paid capital.

From its May 20, 2009 Form 10-Q Quarterly Report filed with the SEC, "The Company has incurred significant operating losses over the past several years and has a deficit accumulated during the development stage of $98.6 million as of March 31, 2009. In addition, as of March 31, 2009, the Company’s current liabilities exceed current assets by $12.7 million. Current liabilities include notes payable of $5.4 million. ...the Company also has an obligation of $3 million to the Company’s Chairman and spouse [they repaid the principal on a company loan and a pro rata portion of accrued interest ]. The Company does not have sufficient cash to support its operations through December 2009. The Company will need to secure significant additional sources of capital in June 2009 to develop its business and product candidates as planned."

On July 9, the company issued a press release saying that between October 1, 2008, and July 7, 2009, Bioheart received proceeds in the amount of $2,855,830 from the placement of restricted common stock and warrants under its current offering which it has now extended through October 2009. There's a little positive spinning here because this would appear to include the approximately $1.8 million raised in the sale of stocks and warrants which it announced back in October 2008. The new ~$1M appears to be coming in dribs and drabs from the sale of small chunks of stock or warrants including, if I'm reading it right, the granting of stock in repayment of an outstanding loan (see the May 2009 Quarterly Report for clarification and details).

FINANCIAL and DEALS

Bioheart, Inc., (OTCBB: BHRT) has raised approximately $1 million over the past few month in an ongoing offering (see details above).

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Continuing on its very active deal-making course to becoming one of the premier sources of stem cell lines, media, antibodies, cultureware, and characterization kits in the pre-clinical end of the cell therapy sector, Millipore Corporation has signed a co-marketing deal with BioTime, Inc. (OTCBB:BTIM) subsidiary Embryome Sciences, Inc whereby Millipore will become a worldwide distributor of the ACTCellerate™ human progenitor cell lines derived from human embryonic stem cells but not fully differentiated into specific cell types

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Not to be outdone by its sub, BioTime, Inc. (OTCBB:BTIM) announced that two of its shareholders have completed the funding of the second tranche of their equity investments in BioTime following the exercise of their rights to purchase additional shares and warrants under the terms of their May 2009 stock and warrant purchase agreements. Broadwood Partners, L.P. and George Karfunkel have each purchased an additional 1,100,000 BioTime common shares and 1,100,000 stock purchase warrants. BioTime received $4,000,000 from the sale of the additional shares and warrants. The warrants, which are substantially the same as BioTime’s publicly traded stock purchase warrants, entitle the investors to purchase additional common shares at an exercise price of $2.00 per share. The warrants will expire on October 31, 2010 and may not be exercised after that date. “The $8,000,000 of new equity capital we have raised since May from these investors, plus our $4,700,000 research grant from the California Institute for Regenerative Medicine, will be available to finance our strategic programs to build our product and technology portfolios in the emerging fields of stem cell research and regenerative medicine,” said Michael West, Ph.D., BioTime’s CEO.

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America Stem Cell, Inc. has been awarded $2.5 million from the Texas Emerging Technology Fund to use in developing its enzyme technology platforms (ASC-101 and ASC-201) designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for cancer patients. Additionally, these platforms have the potential to enhance stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke.

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Aastrom Biosciences, Inc. (Nasdaq:ASTM) has gained a modest extension from NASDAQ to comply with the $1.00 minimum closing bid price rule in order to remain listed on the Nasdaq Capital Market. This means they now have until October 1, 2009 to regain compliance by achieving a $1.00 closing bid price for a minimum of 10 consecutive trading days anytime before that date. If not, they get kicked off the NASDAQ and forced to find another market for their listing. Absent a stock split it seems an unlikely goal give that the stock is currently trading in the region of .35 cents and the 52 range for the stock is 0.15 - 0.78.

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Quantum Immunologics Inc., a Tampa, Fla.-based developer of cancer immunotherpeutics, has raised $2.2 million in VC funding from Mentor Capital, Inc. (Pink Sheets:MNTR). In addition to providing $2.2 Million in funding to help support the FDA trials through approximately February 2010, Mentor Capital has agreed to assist QI in funding future strategic stock or cash acquisitions. Mentor will also stand by as a preferred funding source for QI during later stage or additional trials. This commitment, of course, stands to reason given that QI represents the majority of Mentor Capital’s portfolio assets.

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The good news for StemCyte, Inc recently bagged $1 million in funding; the not as good news for StemCyte, Inc. is that it is a debt funding round from debt financing firm Agility Capital. Agility said that the senior secured growth capital loan closed in June. The firm has previously received venture funding from Sycamore Venture Capital, Asia Star IT Fund and National Technology Enterprise Co. of Kuwait, and the W.I. Harper Group. Agility is a provider of venture debt to high technology and other companies. This blogger speculates the debt financing will be used to fund the company's commitments to a recently announced joint venture, StemCyte Therapeutics India Pvt. Ltd, which is expected to be revenue-generating in the near-term.

CLINICAL

Quantum Immunologics, Inc, a Tampa, Florida company focusing on the research and development of cancer immunotherapies, announced that the first patient in its breast cancer trial has begun to receive its dendritic cell therapy. QI is currently sponsoring and conducting an FDA-authorized Phase I/II clinical trial testing the safety and efficacy of its immunotherapy on 27 Stage IV breast cancer patients who have failed conventional therapy. Each patient will receive three monthly injections of the patient's own dendritic cells that have been sensitized to OFA (oncofetal antigen) - a cancer antigen (a protein found on cancer cells that can be targeted by the body's own immune system) found in many tumor cell lines or fetal tissue, but absent on normal, healthy tissue. When the sensitized cells are injected back into the patient, QI expects the patient's T-cells will locate the OFA found on the patient's cancer cells, thereby generating an immune response with the goal of killing the cancer cells and preventing further spread of the disease.

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Harvest Technologies Corp. announced that the company-sponsored 60-patient clinical trial conducted in Chennai, India using the company's BMAC point-of-care System to treat patients with non-reconstructable Critical Limb Ischemia (CLI) has completed enrollment. Over 300 CLI patients have been treated with the Harvest BMAC treatment protocol in an ongoing multi-center FDA study in the U.S. and other studies in India, Germany and the Czech Republic.

COMMERCIAL

Dendreon Inc (NASDAQ:DNDN) is currently eying Atlanta, GA as the location for a new $80 million, 300-person manufacturing facility. "Why Atlanta", you ask? "Ah, good question", I say. It all comes down to transportation logistics. An autologous cell therapy like Provenge requires the acquisition of a biological sample from the patient which is then used to manufacture a unit of the therapeutic that is then shipped back to the patient's clinical stie for administration. This makes logistics a primary consideration for the business model. Atlanta, has one of the world's busiest and most connected airports.

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Cord Blood America, Inc. (OTCBB:CBAI) has signed a lease for a 17,000 square foot building in Las Vegas, Nevada, for a state-of-the-art laboratory for the storage of multiple stem cell products including umbilical cord blood stem cells. Aggressively the company intents to start processing and storing its customer's umbilical cord blood stem cells in the facility in the fourth quarter of 2009. According the the company CEO, in 2010, CBAI intends to expand its cryogenic storage services to other forms of stem cells, including peripheral blood stem cell and adipose tissues. Presumably this move to self-manufacture will mean that its Corcell banking brand will no longer be able to claim the advantage of cGMP-quality processing and storage which it has made a part of its pitch since contracting with Progenitor Cell Therapy in 2007.

Meanwhile CBAI has picked the pockets of Bio-Matrix Scientific Group Inc (OTCBB:BMSN) by hiring its former Vice President and Chief Operating Officer Geoffrey John O’Neill as its new Laboratory Director and Brian Pockett as Vice President of Laboratory Operations.

In its May 2009 quarterly report, Bio-Matrix Scientific Group Inc (OTCBB:BMSN) reported they had all of $6,621 cash on hand with current liabilities of $1,371,834 such liabilities consisting of Accounts Payable, Notes Payable, Accrued Payroll Taxes, Amounts due to Shareholder, Accrued Expenses and Accrued Interest. Additional financing will be required to meet cash requirements over the next twelve months.

Meanwhile in a weird twist of almost Seinfeld-like interconnectedness, in researching SEC filings for this post I discovered that on August 11, 2008, MSN entered into a Letter of Intent with CBAI regarding the processing and storage by BMSN of cord blood specimens newly acquired by CBAI for consideration acceptable to BMSN. It would appear, however, that deal never materialized given CBAI's recent moves.

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Living Cell Technologies Limited (ASX:LCT; OTCQX:LVCLY) has announced the formation of a subsidiary, LCT Biomedical Limited in Russia, to facilitate the commercial development of DIABECELL®, its lead product for the treatment of type 1 diabetes. Reportedly the regulatory process has already been initiated and it is envisaged that the pivotal study and product would be registrable by late 2011. They recently implanted their 8th patients with DIABECELL, their porcine xenogeneic cell therapy product in clinical trial for type 1 diabetes. The plan is for the product to be manufactured and supplied from New Zealand, where the company is located, for the foreseeable future.

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Progenitor Cell Therapy, LLC has appointed a Vice President of Manufacturing Operations with extensive pharmaceutical production experience to head its two U.S. contract manufacturing facilities. PCT recent announced the recent appointment of Daryl LeSueur as Vice President of Manufacturing Operations. As head of Manufacturing Operations, Daryl is responsible for managing and supervising the day-to-day conduct of the manufacturing, packaging, and operational functions of PCT’s two North American contract manufacturing facilities.

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TheraCell, Inc. aims to develop a revolutionary point-of-care device for isolating and processing stem cells that will facilitate the broad use of autologous stem cells combined with an injectable, highly oxygenated scaffold gel for for advanced regenerative medicine procedures such as spinal fusion. The company recently licensed the underlying technology for the planned device from Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., the technology transfer arm of the University. The technology was invented by a team headed by Professor Dan Gazit from the Faculty of Dental Medicine at the Hebrew University of Jerusalem.

Included in the license was a special scaffold with a particularly high oxygen-carrying capacity, which aims to increase fusion rates by increasing local oxygenation at the surgical site. Scaffolds derived from this technology will act to improve oxygenation and encourage the activity of stem cells and bone-forming cells, or osteoblasts. In preclinical experiments in rodents, accelerated spinal fusion and bone fracture healing were observed, as well as improved stem cell survival. The licensed technology also includes a novel and efficient methods for purifying and manipulating stem cells as well as an innovative, biologically compatible, oxygenated gel that improves bone regeneration and fusion of bone grafts

The company intends to pursue a medical devise status for the combined technologies which would be faster than if it were deems a biologic or combination product.

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In response to Cytori's Request for Designation, Cytori Therapeutics, Inc. (NASDAQ:CYTX) has been informed by the U.S. Food and Drug Administration (FDA) that its Celution(R) 700 System will be regulated as a medical device and reviewed by the FDA's Center for Biologics Evaluation and Research under the law applicable to medical devices. Cytori can now begin to compile and submit a marketing application to the FDA for the Celution(R) 700 System for use as a medical device in "aesthetic body contouring and/or filling of soft tissue voids" - in other words, "breasts". Before they get that far, however, there is still the unresolved issue of whether they will require further clinical trials. Clinical investigations, if required, would be conducted in accordance with the Investigational Device Exemption (IDE) regulations, not the Investigational New Drug regulations applicable to drugs and biologics

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New England Cord Blood Bank, Inc. (NECBB) announced that in August it will begin processing cord blood units using the fully closed and sterile AutoXpress™ System (AXP), developed by ThermoGenesis Corp. and distributed by GE Healthcare. They will, however, continue to operate their manual system, which will allow for processing of samples too small for the automated system. The company hopes that implementation of the automated system will bring NECBB one step closer to accreditation as a public cord blood bank in addition to offering its existing private banking services.

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Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) announced that it has filed its Form 10-K for the year-ended December 31, 2008. The Company anticipates filing its Form 10-Q for its first quarter ended March 30, 2009 prior to the end of July. Upon completing that filing, the Company intends to file for relisting on the Over-the-Counter Bulletin Board as its financial statements will be current.

MISCELLANIA

The ERA Consulting Group is proud to announce the next intERActions seminars entitled:

The Regulation of “Advanced Therapy Medicinal Products*” in Europe, from the Clinic to Approval (*Cell Therapy, Gene Therapy and Tissue Engineered Products)

Topics to be covered:
* The EU regulatory framework for Advanced Therapy Medicinal Products (gene, cell therapy and tissue engineered products)
* Opportunities in the EU regulatory landscape, especially for rare diseases: How can they benefit your company?
* Current and future regulatory guidelines: Latest developments and implications for your company and product portfolio
* What are the EU CMC/quality issues/requirements at various stages of development?
* Preclinical development program: EU regulatory expectations - rational approach
* Clinical trials with Advanced Therapy Medicinal Products in the EU

Including Europe in your Strategy to Add Value to Early-Stage Biotech Product Development

Topics to be covered:
* The value of including an EU component into your overall regulatory strategy
* Optimizing interactions with European regulators and how this can aid development and add value
* The benefits of orphan medical product designation in the EU and an explanation of the procedure
* Clinical Development in the EU: The European Clinical Trials Directive
* Opportunities in the EU regulatory framework to add value and reduce time to approval, such as accelerated review, conditional approval or exceptional circumstances
* Compassionate use programs

The seminars will be held at The GreenV Sustainable Center of South San Francisco on 14th – 15th September 2009. For a complete program and registration information, please visit their website at: www.eraconsulting.com.

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Check out Daniel Kraft's TED talk on his MarrowMiner technology being developed by StemCor Systems, Inc.

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After 15 years in the biotech conference industry, the Williamsburg BioProcessing Foundation has shuttered its operation in financial distress. Hasta la vista, Wilbio.

Sign-off

Ok, this is a stretch for inclusion in this blog which is why I leave it to this humble location in the post but two fellow Canadians have been named among the six researchers to receive prestigious awards from the American Society of Hematology later this year. Congratulations to stem cell researchers Connie Eaves and John Dick.







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Cell Therapy Industry HiLites 2009-05-26

This week I'm ROTFLMAO loving this cartoon so I thought I'd share the chuckles (thanks to www.onstartups.com). I can't tell you how many times in the past years I've seen the inevitable 'hockey stick' market projections graph from companies, analysts, and investors when discussing the coming 5 years in the cell therapy sector. It's become a standing joke about how we just keep pushing the hockey stick out to the right but the curve is inevitably the same. This pokes a little fun at this much maligned tradition.

Maybe it's just because I'm Canadian that I love this so much but c'mon the beloved hockey stick has become almost more a marketing tool than the venerable piece of sports equipment every Canadian boy must own! Maybe we can adapt this new hockey stick model to give the over-used Gartner cycle a run for its money!

Down to business...

I was told last week that Senators have been inviting people to Capital Hill to speak to them about FDA regulation of adult stem cells perhaps at the instigation of Chris Centeno's lobbying through ASCTA (www.stemcelldocs.com) that the medical use of moderately expanded autologous adult stem cells should not be regulated by the FDA but rather self-regulated by physicians. This could, of course, have serious implications on business models for autologous cell therapy companies. I've heard nothing of the Senators asking for ISSCR or ISCT counsel to-date. It would, of course, likely be Centeno's position that anyone involved in those orgs are "pharma hacks" as he has accused me of being.

ASCTA which is comprised of physicians none of whom are acknowledged leaders in stem cell research recently proudly announced the release of their stem cell guidelines which they suggest should replace FDA regulation. In what appears to be simple ignorance of the years of work being done by AABB & FACT, ASCTA described their guidelines as "the world's first clinical guidelines to allow U.S. doctors to safely begin using the patient's own stem cells to treat disease." Their lab practice guidelines contain such gems as:

• Any facility used in the processing A-ASC’s must be of suitable size, construction, and location to prevent contamination.
• The facility should be in a good state of repair.
  
• Equipment used in the facility should be adequately maintained
• In humid areas, dehumidifiers should be used to control the spread of infectious agents in the lab.
• Any reagents used must be approved for human use (where practical).

In an online posting entitled "The FDA is Killing Adult Stem Cell Therapy Thus Killing Patients", ASCTA supporter, Don Margolis, states:

In a startling new interview on stem cell research and adult stem cells in the near future, Dr. Christopher Centeno warns that Big Pharma and the FDA are teaming to control the use of a person’s own stem cells thus slowing innovation and the use of Adult Stem Cells to help patients now.

FINANCIAL

ReNeuron Group plc (LSE: RENE.L) has raised the £3 million it announced it intended to raise. ReNeuron recently received regulatory approval to commence a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. The Company is developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina. ReNeuron has also developed a range of stem cell lines for non-therapeutic applications – its ReNcell® products for use in academic and commercial research. The Company’s ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Millipore Corporation.

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Pfizer expects to pump $100 million into its international stem cell development program which aims to focus both on small molecules that work by modifying cells in the body and cell therapy where the cells are manipulated outside the body. The first major use of the Pfizer money is for a collaboration with University College London (UCL) for the treatment of certain forms of blindness through the London Project to Cure Blindness. The collaboration will attempt to develop stem cell-based therapies primarily for wet and dry macular degeneration (AMD), which Pfizer has the rights to progress through clinical trials and then commercialize. Pfizer’s work on this could potentially provide a boost for the cash-strapped and searching-for-a-buyer, Intercytex Group plc (AIM: ICX), whose involvement on the London Project could yield cash royalties. But that's not where the Pfizer-Intercytex connection may end, apparently. Reports indicate that Pfizer is in fact eyeing the troubled Intercytex as a potential acquisition or investment. The company is on the auction block and actively seeking suitors.

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Cytori Therapeutics, Inc. (NASDAQ: CYTX) expected to close a private placement for $4.2 million by May 11. No word yet...

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Cord Blood America, Inc. (OTCBB:CBAI) has received a commitment for up to $2.3 million of new funding to acquire or build its own state-of-the-art laboratory for the storage of multiple stem cell products including umbilical cord blood stem cells. Less than two years ago the company signed a deal with Progenitor Cell Therapy LLC to process and store their stem cell units on a contract basis. Now CBAI says having their own facility will over the long term reduce their costs for both the processing and storage and additionally allow CBAI the flexibility and capacity to pursue new sources of revenue such as the storage of adipose tissue and peripheral blood stem cells processing and storage much easier than under the current structure of outsourced relationships.

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Core Dynamics announced it has recently closed on a new financing round of US$17.9 million institutional and private investors. The money will be used to further develop the company's process for freeze drying human stem cells to be stored at room temperature.

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Bioheart, Inc. (OTCBB:BHRT) announced today that its common stock is now being quoted on the OTC Bulletin Board (OTCBB) under the trading symbol "BHRT," the company's original ticker symbol.

CLINICAL

Aastrom Biosciences, Inc. (Nasdaq:ASTM) temporarily suspended enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. IMPACT-DCM is a clinical trial to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event. The Company has voluntarily suspended patient enrollment and treatment in the trial and the FDA placed the trial on temporary clinical hold pending an investigation.

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ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB ) (IMUC) announced that clinical data from the company's Phase 1 trial of its antigen-pulsed dendritic cell immunotherapeutic cancer vaccine ICT-107 for patients with brain stem glioma and glioblastoma will be presented at this year's ASCO. Having said that, they also said that while "encouraging data" was observed from the phase I trial of ICT-107, IMUC's primary focus going forward will be on its lead product candidate, ICT-121, which is an peptide-based "off-the-shelf" cancer vaccine that targets cancer stem cells and may have applicability to multiple types of cancer. IMUC anticipates filing an Investigational New Drug (IND) application in the third quarter of 2009 for a Phase I trial of ICT 121 in the treatment of glioblastoma (brain cancer).

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Little-known, Memgen, LLC will be presenting results from a recently completed phase I clinical trial of its novel active immunotherapy product, ISF35, in patients with high-risk, progressive chronic lymphocytic leukemia (CLL), at next week's ASCO meeting. According to the study's principle investigator, Dr. Castro, one injection with no chemotherapy resulted in durable reductions in lymph nodes and spleen size in most patients and three of fifteen patients with rapidly progressing disease did not require any further treatment for more than one year. Based on the results from this single injection study, a phase II trial evaluating multiple intranodal injections of ISF35 in CLL has begun funded by - of all things! - the Food and Drug Administration at UCSD. The company believes the product is also positioned for use in lymphomas and solid tumor cancers.

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Aderans Research Institute Inc. (ARI) announced it has launched Phase 2 of its clinical study on cell-based hair regeneration for men and women. The company's research is focused on developing a state-of-the-art tissue engineering solution to the regeneration of hair, taking actual hair cells--fibroblasts and keratinocytes, the two primary cell types within hair follicles--and promoting their growth in controlled laboratory environments. The research teams then recombine them and these "combined hair cells" are then placed in the patient's skin, where they are expected to elicit hair growth.

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Cytori Therapeutics, Inc. (NASDAQ:CYTX) completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, named the PRECISE study, was designed as a double-blind, randomized, placebo controlled, dose escalation study specifically enrolling patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients in a study involving the patients’ own cells extracted from adipose tissue and processed for delivery at the point of care using Cytori’s Celution® System. The cells were then injected back into the patients using the NOGA® XP System (Biologics Delivery Systems, Cordis Corp., a Johnson and Johnson company). Primary endpoints were safety and feasibility of Cytori’s Celution® System as part of a novel procedure for chronic heart disease.

A major attribute of the Celution® output is that it is comprised of multiple cells types. This, the company believe, contributes to multiple mechanisms of action, and thus increases the potential to restore heart function. The Celution® System used in PRECISE was configured specifically for cardiovascular disease, including proprietary processes and enzymes needed to achieve a level of purity required for vascular delivery.

COMMERCIAL

Cytori Therapeutics (NASDAQ:CYTX) and GE Healthcare, a unit of General Electric Company (NYSE:GE) announced an agreement by which GE Healthcare will commercialize Cytori's StemSource(R) technology in the North American stem cell banking and research markets. The StemSource technology includes automated equipment to process stem and regenerative cells found in adipose tissue, cryopreserve them or use them directly for research purposes. In January 2009, Cytori and GE Healthcare formed a separate agreement to commercialize Cytori's products in ten European countries. This includes selling the Celution(R) 800/CRS System in the European cosmetic and reconstructive surgery market as well as selling StemSource products in the European cell banking and research markets. The recent partnership is similar in nature to the European agreement, but is limited to the sale of StemSource banking and research products in the U.S., Canada and Mexico for 18 months starting in the second quarter of 2009. The agreement does not include U.S. commercialization of Cytori's Celution System, which is currently under review by the FDA.

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Celsense, Inc. has announced the formal opening of its new and expanded R&D facility said to be a key component to Celsense’s commercialization strategy for its pre-clinical and clinical-grade molecular imaging agents used to non-invasively visualize and measure cellular activity and biodistribution. The company is now actively bringing both their lead research and clinical-grade cellular and molecular imaging agents to market over the coming months and is said to be collaboration with several academic and industry parties currently evaluating our products for potential use in their discovery research or clinical protocols.

Their clinical-grade Cell Sense reagent is a fluorocarbon tracer agent used to label cells in vitro then transplanted thus enabling investigators and clinicians to non-invasively track the administration and delivery of therapeutic and diagnostic cells in vivo using MRI. Applications include tracking therapeutic cells in regenerative medicine and immunotherapy applications, and observing localized immune system response by tracking populations of immune system cells. The research-grade V-Sense is an injectable fluorocarbon MRI tracer agent that labels leukocytes in situ, enabling the direct, non-invasive observation of immune system response and localized inflammation. Applications include observing change in immune system response to therapeutics and mapping localized disease such as certain cancers and infections.

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After securing a $12M equity financing facility and closing a $1.5M private placement, formerly on-the-rocks Melbourne-based Prima BioMed (ASX: PRR), which had less than $500,000 in the bank at the end of December, is now preparing IND filing in the US for a phase IIb / III pivotal trial of CVac for ovarian cancer. As previously reported here, the company has also commenced CVac™ ovarian cancer treatments on selected patients in Australia made possible through the Australian Government’s Australian Regulatory Control Mechanism’s Special Access Scheme under the Therapeutic Goods Administration. Meanwhile the company is looking at taking the product to other countries as a means of generating cash flows in the short-term through the sale of CVac™ treatments. Now the company's executive director, Mr Martin Rogers, is touring North America in discussions with a number of hedge funds and other biotech focused investment funds about new investment and partnering opportunities for the commercialization of CVac.

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Progenitor Cell Therapy, LLC has done a deal with NeoStem, Inc. (NYSE Amex: NBS) as their exclusive provider of commercial adult stem cells processing and storage. Progenitor founder, Andrew L. Pecora, has also joined NeoStem's Advisory Board.

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NeoStem, meanwhile, - the new favorite company of alternative "medical" products promoter, Suzanne Sommers - has been busy the last few weeks creating a curious empire of sundry types of bedfellows. Recently the company announced it had signed an agreement to license the exclusive worldwide rights to a technology, with pending patent applications, developed by Vincent Falanga, M.D., Chairman of the Department of Dermatology and Skin Surgery at Roger Williams Medical Center, Providence, R.I. Dr. Falanga's stem cell product under development, Primcel, is a mesenchymal stem cell (MSC) product. Early clinical studies are said to indicate that Primcel can be used to accelerate or jump start healing of chronic wounds. Dr. Falanga's work seeks to develop a prepackaged product created from a patient's own cells, ready for physician use in a clinical setting, consisting of three applications over a 12-week period.

Almost in the same breath, the company filed a patent application claiming the proprietary stem cell technology of Vincent C. Giampapa, M.D., F.A.C.S. relating to cosmetic facial rejuvenation, which NeoStem first licensed in February 2009. Dr. Giampapa is director of the Giampapa Institute for Anti-Aging Medical Therapy, a board-certified plastic reconstructive surgeon and Assistant Clinical Professor of Plastic and Reconstructive Surgery at the University of Medicine and Dentistry of New Jersey. His cosmetic stem cell face lift technology is said to comprise a "non-surgical procedure for complete facial rejuvenation that involves injecting pluripotent cells, including stem cells, into the skin of individuals whose skin has lost its firmness and texture due to age".

Days later NeoStem announced it had signed an exclusive royalty-bearing license agreement for the Asia territory for a procedure developed by Regenerative Sciences, LLC and marketed for the treatment of chronic orthopedic conditions, under the name, Regenexx. Additionally, Regenerative Sciences, through its founder and CEO, Christopher Centeno, M.D., will serve as a consultant to NeoStem, Inc. in the area of stem cell therapy in orthopedics.

Undoubtedly Centeno will also embroil and leverage NeoStem in his fight with the FDA about the marketing of Regenexx in direct flagrance of FDA regulation. In any event this is clearly a solid "plan B" for Centeno should the FDA ever get around to shutting him down in the U.S. In the interim, Centeno continues to strengthen his network of supporters and is reportedly actively working Capital Hill for support for his fight.

To mix it up a little, NeoStem then announced they had signed a deal to promote and glean royalties from the sale of a liquid, nutritional supplement - AIO Premium Cellular Health. Not kidding. They have signed an agreement for Ceres Living, Inc., a developer and direct marketer of health and wellness products. AIO Premium Cellular Health was apparently developed in conjunction with NeoStem's scientists and Advisory Board members, based on certain nutraceuticals that have been shown to "optimize stem cell functions". The promotion of AIO is said to be "part of NeoStem's corporate commitment to advancing anti-aging and regenerative medicine therapies and technologies."

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Novocell, Inc. announced that it has received U.S. Patent # 7,534,608 with with wide-ranging method claims covering the Company’s innovative stem cell therapy for the production of functional pancreatic, insulin-producing cells from human embryonic stem cells (hES). Novocell’s therapy is being developed as a method for the use of hES cells to replace insulin-producing pancreatic cells that are destroyed in people with diabetes.

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Neuralstem, Inc. (NYSEAmex:CUR) recently published a reaction to a press release by StemCells, Inc. (STEM) refuting many of their statements in what has become a very public dispute. Included in the reaction is the claim that "the PTO upheld the patentability of Neuralstem’s core technology in May, 2006, in response to a challenge from STEM" and that the Neuralstem "patents are not being challenged in the PTO or in any of the suits with STEM".

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This is not a cell therapy story but it could be. Takeda Pharmaceutical Company Limited (TSE: 4502) and IDM Pharma, Inc. (Nasdaq: IDMI) today announced that Takeda America Holdings, Inc., a wholly-owned subsidiary of Takeda (Takeda America), and IDM Pharma have entered into an agreement for Takeda America to acquire IDM Pharma. Takeda America has established Jade Subsidiary Corporation as a wholly-owned subsidiary to effect that transaction. Under the agreement, Takeda America will purchase all of IDM Pharma's outstanding shares for US$2.64 per share in an all cash tender offer followed by a merger.

You may recall that on April 1 last year (omen perhaps?), Cell Genesys, Inc. (“Cell Genesys”, Nasdaq: CEGE) and Takeda announced that the companies had formed a global alliance for the development and commercialization of GVAX immunotherapy for prostate cancer, Cell Genesys' lead product candidate then in Phase 3 clinical development. Under the agreement, in exchange for exclusive worldwide commercial rights to GVAX immunotherapy for prostate cancer, Takeda was to pay Cell Genesys an upfront payment of $50 million and additional milestone payments totaling up to $270 million relating to regulatory approval and commercialization of GVAX immunotherapy for prostate cancer in the United States, European Union and Japan.

This deal quickly unraveled when they decided to mothball both phase 3 studies of GVAX on statistical likelihood of failure. This was Takeda's big venture into cell therapy and it is an ugly, recent memory. Now they have bought IDM Pharma. They 've bought it for the company's primary asset, MEPACT, (mifamurtide), a macrophage activator drug therapy indicated for the treatment of non-metastatic osteosarcoma (malignant bone cancer) following surgical removal of the tumor (resection) in children, adolescents and young adults.

Here's the cell therapy part: IDM Pharma has 3 autologous cell therapy products currently on developmental hold as a means of perserving resources to get them to the home run on MEPACT. BEXIDEM is activated macrophages (Monocyte-derived Activated Killer cells or MAK® cells) for bladder cancer. UVIDEM, for melanoma, and COLLIDEM, for colorectal cancer, are both therapies using dendritophages (specialized immune cells derived from the patient's own white blood cells). It will be very interesting to see what Takeda does with these products, if anything.

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Veterinary stem cell company, Vet-Stem, Inc, has now expanded from its US base into Canada, providing commercially available autologous, adipose-derived stem cell tranplants for horses and dogs.

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According to the Seattle Times which played a critical role in exposing what is now alleged to be potential fraud, CellCyte Genetics, "left a cashless zombie after the stock-touting campaign that lifted its value to $400 million faded away, says it has reached a tentative settlement in the Securities and Exchange Commission (SEC) inquiry into its activities" but it still faces a criminal probe and the "number of lawyers embroiled in the company's legal troubles have now outnumbered the company's peak work force".

MISCELLANEA

International Stem Cell Corporation (OTCBB:ISCO), the company behind human stem cells from unfertilized eggs (called “parthenogenetic stem cells”), submitted comments to NIH on their draft stem cell research guidelines issued by the National Institutes of Health (NIH) on April 17, 2009. ISCO then published its comments in a press release and then their CEO published a blog to address questions regarding their comments.

Genetics Policy Institute also submitted a letter to the National Institutes of Health (NIH) commenting on the Draft Guidelines for Human Stem Cell Research. The complete letter is available at www.genpol.org for public viewing.

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The California Institute for Regenerative Medicine is working its way through Congress seeking $500 million in federal funds it hopes to apply toward guaranteeing the long-planned small-business loan program.

Forbes published what is actually quite an informative article on cell therapy medical tourism for a change.

Sign-off

If you've read this far you're obviously interested in the cell therapy industry. If you're on LinkedIn make sure you have joined the LinkedIn Cell Therapy Industry Group.

Thank you all for all your good wishes about the new addition to my family - my own little sample of regenerative medicine! Now I gotta go and spend some time with her before I'm enrolling her in college...

Remember. Cell Therapy Means Business.

Cell Therapy Industry HiLites 2009-03-06

I have silly and serious news. Apparently within just one hour after taking a capsule of the "wonder supplement" from the bottle pictured to the right, 3-4 million stem cells will be added to my bloodstream and go to work repairing and regenerating my body! That's the silly part. The serious part is that I'm told they made $1 million in the first month of sales.

This week was marked by another clinical hold (sorry I can't tell you who), a release from clinical hold (Aastrom), some significant M&A, and my inability to keep pace with the pace of revolutionary changes in new ways to make iPS cells - ways which appear safer and hold more promise for the eventual therapeutic potential of these cells. I have to confess to not really getting on the iPS bandwagon until last week when I heard some great talks and really just spent some time trying to understand what all the fuss was about. As usual, Monya Baker has put together a nice summary of this week's IPS progress.

For those of you who haven't seen it yet, this year's TED talk by Juan Enriquez (Beyond the crisis, mindboggling science and the arrival of Homo evolutis) is a fascinating insight into what he cites are three 'evolving' trends that will change society as we know it and should be considered when looking beyond the current financial crisis. The ability to engineer cell-based therapies is one of them.

And now, for the news and analysis ...

FINANCIAL

The big news of the week was StemCells Inc. (STEM) announcement that it has agreed to acquire the operating subsidiaries and assets of Stem Cell Sciences PLC (STEM.LN) for 2.65 million StemCells Inc. shares. At its closing price of $1.56 per share Feb. 27, the deal values Stem Cell Sciences at $4.85 million. Shareholders representing 30% of Stem Cell Sciences have backed the deal. "The industrial logic of this acquisition is compelling," said Martin McGlynn, president and chief executive of StemCells. StemCells' expertise is with stem cells for therapeutic uses, while Stem Cell Sciences has focused on non-therapeutic applications like assays for drug discovery. For more details see my post from earlier this week.

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Athersys, Inc. (Nasdaq:ATHX) today announced it will host its first annual Investor Day being held at the Intercontinental Hotel on Wednesday, April 8th, 2009 in New York City. The meeting will begin promptly at 8:30 a.m. Eastern Time and end at approximately 11:30 a.m. Eastern Time. Institutional investors and analysts interested in attending should contact Lisa Wilson, Investor Relations for Athersys: details available at the company website.

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Hon Hai Precision Industry Co has invested in local cell-tissue banking and cell therapy company Bionet Corp (TPO:1784) through the purchase of NT$100 million (US$2.86 million) in Bionet shares. The purchased shares represent 8.6 percent of Bionet’s outstanding shares. The two companies plan to invest an additional NT$200 million in a joint venture called Conn Lian, aimed at developing next-generation health care focused on predictive, preventive, personalized and participatory medicine. Hon Hai will take 50 percent ownership of the newly formed company, while Bionet and the rest of the investment consortium will each take 22.5 percent and 27.5 percent. Bionet is engaged in the storage and application of stem cells, as well as gene detection. Under the name BabyBanks, the company provides stem cell banking from cord blood, umbilical cord, placenta, teeth, and mobilized peripheral blood stem cell storage in mutiple Asian countries.

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Adam Feuerstein, the irreverent biotech analyst at TheStreet, has identified 10 key upcoming events he says will play a leading role in determining how well biotech stocks perform as we move from a cold winter to spring. Among his top picks for market moving events? Phase III data on Dendreon's(NASDAQ: DNDN) Provenge expected to be released within the next 60 days.

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Advanced Cell Technology, Inc. (OTC: ACTC) continues, once again, to provide evidence of its veritable immortality, with an an announcement that it has received a total of $400,000 in additional funding through NIH research grants and the receipt of the final payment in connection with its recently formed international joint venture with CHA Biotech Co, Ltd., its Korean-based biotechnology company focused on the development of stem cell technologies. Proceeds from these transactions as well as other transactions in advanced discussions will be used to support the Company's retinal pigment epithelium cells (RPE) program. The Company anticipates filing an IND with the FDA during the second half of this year.

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Bioheart, Inc. (Nasdaq:BHRT) got a notice of delisting from the NASDAQ Capital Market. The Company is in the process of engaging a market maker for its common stock and causing the required application to be filed for quotation of the Company's common stock on the OTC Bulletin Board. Howard Leonhardt, Chief Executive Officer of Bioheart, commented: "It is unfortunate that Bioheart's stock price has been so adversely affected by the general decline in the securities markets that it could not maintain its NASDAQ listing. The Company has been current in its filings with the SEC and there are many good things happening at Bioheart with regard to the commercialization and sales of its products that we expect will add value to the company's equity. We look forward to re-establishing a robust market for our shares and having them approved for quotation on the OTC Bulletin Board."

Of course IguanaBio's couldn't help but take a lighthearted look at the unfortunate news...

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Isolagen, Inc. (AMEX:ILE) currently estimates that its unrestricted, available cash resources will allow the Company to continue in operation for approximately three weeks. The Company continues to pursue potential financing alternatives and potential strategic partnership discussions. As previously disclosed, the Company currently has a debt liability of approximately $89.7 million related to its 3.5% subordinated notes, which could be called due, at the option of the note holders, as early as November 2009. Interest on the notes is due semiannually on May 1 and November 1. The Company is pursuing the potential sale of its 57% ownership interest in Agera Laboratories, Inc.

In the meantime, Isolagen is reporting positive clinical news and is on brink of filing a BLA.

CLINICAL

Isolagen, Inc. (AMEX:ILE) announced positive top-line efficacy results from a Phase II/III clinical study (Study IT-A-008) of the Isolagen Therapy for the treatment of moderate to severe acne scars. The study met all primary efficacy endpoints and was statistically significant, making this a major clinical milestone for the Company. The Phase II/III, placebo-controlled study investigating the efficacy and safety of Isolagen Therapy for the treatment of moderate to severe acne scars evaluated a total of 109 people at seven clinical sites across the United States. In the study, both the Patient and Evaluator assessments met the co-primary endpoints and were statistically significant.

The Company believes that to ultimately obtain FDA approval with respect to the acne scar indication, the Company will require FDA concurrence with the use of the Company's Evaluator Live Acne Scar Assessment scale, which the Company developed specifically for use in this study and which has not been previously used in a clinical trial. Further, if the Company obtains this concurrence from the FDA, then the Company will also require, at a minimum, one additional Phase III study to complement study IT-A-008 in order to pursue FDA approval and licensure.

The production process for the Isolagen Therapy is a proprietary cellular processing system that creates a natural, living cell therapy. By multiplying a person's own collagen-producing cells, or fibroblasts, into tens of millions of new cells, a personalized treatment is created that is then returned to the person's skin. Isolagen Therapy, is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns.

The Company is preparing to submit its Biologics License Application (BLA) for Isolagen Therapy for the treatment of wrinkles/nasolabial folds and currently expects this submission to occur within two weeks.

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Cytori Therapeutics, Inc. (NASDAQ: CYTX) completed enrollment in its APOLLO trial to evaluate the safety and feasibility of adipose tissue-derived stem and regenerative cells, processed with the Company’s Celution® System, in the treatment of severe heart attacks. According to the company, the steering committee deemed, in concurrence with data safety and monitoring board (DSMB), that the safety and feasibility goal in APOLLO was met in thirst cohort of 12 patients at the initial cell dose and that the procedure did not raise safety concerns. Cytori has said they will report results on the primary six month follow up period for the APOLLO trial in late 2009.

“... we needed to show that the fat harvest could be done safely on sick heart attack patients and that we could re-deliver the stem and regenerative cells back to these patients through the coronary artery in the same surgical procedure early in the peri-myocardial infarction period", said Marc H. Hedrick, M.D., president, Cytori Therapeutics.

The steering committee has recommended that a pivotal study be conducted to further evaluate efficacy. Cytori is presently in discussion with its notified body in Europe to negotiate study size needed to show efficacy and achieve reimbursement.

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Aastrom Biosciences, Inc. (Nasdaq:ASTM) reported that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from the Company's U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at the four initiated clinical sites. The IMPACT-DCM trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure. George W. Dunbar, President and Chief Executive Officer at Aastrom has said that the company still anticipates completing patient enrollment in this trial by the end of calendar year 2009.

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Pluristem Therapeutics Inc. (NasdaqCM:PSTI)(DAX:PJT) announced that the US Food & Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to initiate a Phase I clinical trial for the treatment of Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD), using Pluristem's PLX-PAD. In this Phase I dose ranging trial, to be conducted at multiple locations in the US, PLX-PAD will be administered to patients considered "late stage" and defined as patients afflicted with CLI that have not responded to traditional medical or surgical interventions.

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Opexa Therapeutics, Inc. (NASDAQ:OPXA) announced that continuing analysis of the data^® for Early Relapsing Multiple Sclerosis) for the treatment of MS, has shown that Tovaxin® Multiple Sclerosis therapy shows significant improvement in visual impairment. An analysis of the MS Quality of Life Inventory Data (MSQLI) from the 150 patient study has shown that in the complete modified intent to treat (mITT) population (n=142), patients treated with Tovaxin demonstrated a statistically significant improvement in the Impact of Visual Impairment Scale scores (p=0.028) compared to those on placebo. This improvement was observed within six months of completing the full course of treatment. Visual problems are a common, often disabling symptom in MS and according to the National Multiple Sclerosis Society can affect over 40% of patients. The Impact of Visual Impairment Scale consists of 5 items that assess the extent to which various activities dependent upon vision are affected by MS-related visual problems.

The company is now on life-support levels of cash and continues evaluate a number of strategic opportunities and advance partnering discussions for both their T-cell technology in MS and stem cell technology in diabetes.

COMMERCIAL

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) announced it has signed a collaboration agreement with Pharmicell Europe GmbH. Under the Agreement, Pharmicell will distribute PLX-PAD, Pluristem’s placental-derived adherent stromal cell product, to various clinical sites in Germany, in connection with Pluristem’s upcoming clinical trials for the indication of Critical Limb Ischemia. Pharmicell will distribute PLX-PAD to the clinical sites at Charité-Universitätsmedizin, and Franziskus-Krankenhaus, both located in Berlin. “PLX-PAD should be stored in a location close to the clinical sites in Berlin, so it could reach the patients in a timely manner when treatment is required,” stated Zami Aberman, Chairman, President and CEO of Pluristem. “Collaborating with Pharmicell gives Pluristem the advantage of storing this ready-to-use cell product under stringent conditions in a German regulated facility prior to dispensing it for patient use,” he added.

Pharmicell Europe GmbH was founded in Berlin in 2006 with the goal of providing consumers with new adult stem cell therapies. Having completed preclinical trials for stroke and myocarditis with Charité and BCRT, in 2009 Pharmicell intends to commence clinical trials using fat-derived cells for plastic and aesthetic therapy for European customers. Pharmicell aims to open a specialized stem cell treatment center. As the European subsidiary of FCB Pharmicell Co. Ltd., based in South Korea, Pharmicell Europe’s R&D laboratories are located in the Center of Berlin and in the Europarc Dreilinden in Brandenburg which hosts Pharmicell’s GMP certified cell production area.

Pharmicell Europe GmbH is not to be confused with Pharmacell BV, the Dutch-based cell theapy contract manufacturer. Formed in 2005, Pharmacell is a contract services company which also has Asian connections. In 2006, CyGenics Ltd. (ASX: CYN), a cell therapy, tools, and services company with operations many of the countries in Asia, bought what was then a 20% stake in Pharmacell. The investment came with an option - which to the best of my knowledge, if still alive, has not been exercised - to purchase the remaining 80% at a later date. Since then the company attracted €2 million in an early 2007 financing from other sources.

Then late last year, Tokuda Hospital Sofia and the Maastricht-based PharmaCell announced an agreement to establish a joint-venture to build and operate a GMP facility in Sofia, Bulgaria. Tokuda Hospital Sofia is owned by the Tokushukai Medical Corporation, one of the largest health institutions in the world with over 280 health care facilities in Japan; among which 65 hospitals. Tokushukai Medical Corporation is expanding its activities outside Japan. The Tokuda Hospital Sofia is the first of these expansions and is reportedly one of the most modern hospital in Eastern Europe. The joint-venture will build a 'world-class" GMP facility focussed on human cell & tissue culturing in the Tokuda Hospital. From there it intends to serve the whole Eastern European Region for these treatments. The total investment in the Sofia Facility is reported to be €5 million and construction was scheduled to start in early 2009.

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Israeli firm, Piercell, has announced a collaboration with immuno, cell and gene therapy expert, Dr. Cyril Cohen. Piercell aims to integrate its innovative biomolecular delivery device - a robust transfection solution for primary and hard to transfect cells - with cell therapy protocols such as Dr. Cohen's.

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Privately-held Stemedica Cell Technologies, Inc. as been on a very public company and profile-building campaign since the beginning of the year. In January, they announced the appointment of Dr Nabil Dib, MD as Special Advisor to its Board of Directors and the appointment of Michael Bayer, MD, as Director, Medical Services, responsible for developing pre-clinical and clinical trial protocols. In February, they announced the appointment of Riccardo Nisato, MBA, PhD, as Director of Manufacturing and Clinical Business Development of Stemedica International, CH. Dr. Nisato will be responsible for replicating Stemedica's U.S. based operations to Stemedica's International's center based in Lausanne, Switzerland. February also saw the announcment that they had filed with the Food and Drug Branch of the State of California's Department of Public Health for a California Drug Manufacturing License for adult stem cells for U.S.-based Phase I and Phase II clinical trials at the their facility in San Diego, California. The company rounded out the month publishing a commentary on the PLoS Medicine article published online February 17, 2009 describing a patient who developed “brain tumors” (glioneuronal neoplasms) after undergoing repeated transplants of “fetal neural stem cells” in Russia starting in 2001.

This first week of March saw Stemedica announce that the leadership of the California Institute for Regenerative Medicine (CIRM) had recently completed a two part visit of their manufacturing facility, R&D lab and corporate headquarters. It's not entirely clear to me why CIRM has blessed Stemedica with not just one but two visits when to the best of my knowledge it has not nor does it have any plans to visit the other two corporate contract manufacturers in California.

Furthermore, CIRMS's President, Alan Trounson is quoted as saying: "I was glad to have the opportunity to visit Stemedica and get to know more about its leadership, plans for the future and to see first hand the assets and potential they represent to the stem cell movement in California. We want to have strong working relationships with all sectors of California's stem cell industry, including for-profit companies like Stemedica."

The praise from CIRM didn't stop there. Dr. Marie Csete, CIRM's Chief Scientific Officer is quoted as saying, "We're delighted to see Stemedica make the effort to secure a clinical grade manufacturing license from the State of California. We believe this capability will aid numerous organizations in California and around the world in their efforts to manufacture stem cell products for clinical application."

Just to round out what sounds like a veritable love-in, Stuart Lipton, M.D., Ph.D., Scientific Director and Senior Vice President of the Del E. Webb Center for Neuroscience, Aging and Stem Cell Research at the Burnham Institute for Medical Research, San Diego, CA, who joined Dr. Trounson during his visit to Stemedica's manufacturing facility provides the following statement of affection: "I was impressed with the progress that Stemedica has made on the licensing process for clinical grade allogeneic stem cell manufacturing and am excited about expanding our research relationship with the Stemedica team. Having a manufacturing resource like this in California will be a great asset to our entire research community. I anticipate that many CIRM-funded stem cell research institutions will take advantage of Stemedica's manufacturing facility that will soon become FDB (Food & Drug Board) cGMP licensed."

It's hard to imagine that CIRM could provide a more overt and public statement of support for a company which will likely be, if it has not already, vying for its funds as one of several contract service providers in California. This is a curious position for a granting agency like CIRM and certainly carries with it the risk of the perception of preferential treatment or bias. I will certainly be following this up with CIRM.

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Off-shore stem cell clinics continue to gather steam. Local news coverage from Texas is an example of the kind of media attention being given these companies every day by telling the stories of dozens of American patient testimonials for these off-shore healers. Today's example is the Institute for Cellular Medicine ("ICM") operating under the name Cell Medicine out of San Jose, Costa Rica. They are treating Autoimmune Diseases, Cerebral Palsy, Critical Limb Ischemia, Degenerative Joint Disease, Diabetes Type II, Heart Failure, Multiple Sclerosis, Osteoarthritis, Rheumatoid Arthritis and Spinal Injury with an autologous concoction for stem cells.

ICM is, in fact, a licensee of Medistem Inc. (OTC BB:MEDS.OB). The two entities were consolidated reporting companies until December, 2007 when for various financial and commercial reasons it was seen beneficial to seperate the entities somewhat though ICM is controlled by the Company’s Chairman and majority stockholder.

Last year MediStem also entered into a licensing agreement with a third party for the exclusive use of certain Medistem technologies and know-how in the countries of India, Malaysia, Pakistan, Bangladesh, Sri Lanka, Nepal, Maldives, Bhutan, Afghanistan, Indonesia and Thailand. In exchange for the grant of the exclusive license, the Company received cash, a non-controlling equity interest in the licensee and a license to use and commercialize all of the third parties’ current and future stem cell technologies. They also, I believe have a similar licensee in Mexico.

Medistem Inc., formerly Medistem Laboratories, Inc, is a U.S. based biotechnology company focused on the development and commercialization of adult stem cell-based technologies used in the treatment of inflammatory and degenerative diseases. Their primary focus is commercialization of their "endometrial regenerative cell” (“ERC”) sourced from menstrual blood. These cells originate in the endometrium where they are believed to have one vital function: to make new blood vessels (angiogenesis). Stimulation of this process is believed to offer hope for patients with circulatory disorders in which certain tissues are lacking oxygen because of restricted blood flow. As reported here, Medistem filed its first IND in January for a phase I trial of its ERC cells for use in the treatment of critical limb ischemia.

RESOURCES & EVENTS

Pittsburgh Symposium on Molecular & Cellular Imaging. April 3-4, 2009.
Carnegie Mellon University

Molecular and Cellular Imaging enable the visualization of cellular trafficking, cellular function, and molecular processes in living organisms. In the coming years, these rapidly developing disciplines will provide an avenue to translate basic biomedical science to clinical breakthroughs for numerous diseases and cancers, as well as a means to monitor drug targeting and cellular therapies. Carnegie Mellon University and the University of Pittsburgh will host a 1-½ day symposium on Cellular and Molecular Imaging to showcase current cutting-edge research in areas of Magnetic Resonance Imaging (MRI), Positron Emision Tomography (PET), Optical Microscopy, and Ultrasound.

Registration is free, but space is limited.

Faculty includes:
Joseph J. H. Ackerman, Washington University at St. Louis
Eric T. Ahrens, Carnegie Mellon University
Ronald Blasberg, Memorial Sloan-Kettering Cancer Center
Jeffrey W. M. Bulte, Johns Hopkins University
Christopher H. Contag, Stanford University
Alan P. Koretsky, National Institutes of Health
Martin G. Pomper, John Hopkins University
Stephen H. Thorne, University of Pittsburgh

Stanford's Office of Technology Licensing (OTL) has just released technologies that may be of interest. The technologies are titled: Multipotent Neural Stem Cells Derived From Human Embryonic Stem Cell.

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International Stem Cell Corporation Hosts Webinar, "Stem Cells 102: Beyond Embryonic Stem Cell Research," Thursday, March 12, 2009, From 1:00pm-2:00pm EDT

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International Stem Cell Corporation (OTCBB:ISCO), whose primary technology is human "parthenogenetic" stem cells from unfertilized eggs, will host a webinar titled "Stem Cells 102: Beyond Embryonic Stem Cell Research," Thursday, March 12, 2009, from 1:00pm-2:00pm EDT. This free educational webinar is for journalists, shareholders, and investment professionals interested in learning about new emerging technology in the stem cell research arena. Please note that space is limited. Interested parties are invited to make a reservation to participate in the webinar by using this link.

Covered in the webinar: What is a pluripotent stem cell? What are the implications of the FDA's recent approval of Geron clinical trials? What is parthenogenesis and how does this process solve certain ethical and immune rejection issues that have long shadowed stem cell research? How close are we to treating diseases with stem cells?

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Dr. Kiki Sanford, the hula hooping, TKD black-belt wearing, radio show producing physiologist- now-science-journalist, blogger and 'sexy geek' at The Birds Brain has posted a little inaptly named but nontheless useful, easy-to-read-for-the layperson-summary of the history of iPS cells entitled "A Brief History of Stem Cells".

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ISCT would like to ask for your assistance with completing a survey on quality plan implementation. The results will be presented at the 2009 ISCT Annual Meeting.

Sign-off

So...here I am once again a little off my Friday target but don't you dare complain!

That's all the business news and analysis I could muster. I think the news this week certainly reflects the times. We had companies with money scooping up companies without it, we have companies on the brink of commercial products that are struggling to raise enough money to get to the finish line, more paradigm-shifting scientific breakthroughs, some signs of significant investment still proceeding outside the U.S. and a few more shenanigans on the periphery of the sector that we hope don't malign the industry by association.

That, my friends, is a wrap on my insights into the cell therapy biz for this week.