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 2009-02-06

Following on the heels of FDA's approval for Geron's trial, I suppose it's not surprising that TIME magazine put stem cell research as its cover article. But while stem cell research enjoys the glory and any stock even remotely related to cell therapy is enjoying a bullish run, CIRM - one of the efforts responsible for keeping stem cell research alive in the US during the last 8 years - is being threatened by California's crushing debt.

It was an interesting week at the Phacilitate Cell & Gene Therapy Forum last week. In some ways it was a little Dickensian - the best of times; the worst of times. On one hand we had Genzyme-Osiris talking about the biggest deal ever in cell therapy, both Osiris and Dendreon potentially being on the verge of the first cell therapy BLA approval in a decade, and the pharma industry coming out of the closet speaking about their belief in cells as therapies not just tools for discovery or toxicity testing. On the other hand, the fact that money has pulled a disappearing act on many who thought they had it or been freeze-dried in the pockets of those who still do, makes it nervous times for a bulk of the industry. This is a sector that may look drastically different at the end of the year than it did at the beginning and while this will make for tough decisions, may impeded some progress, and generate many a sleepless night... an industry re-org may not be an entirely bad thing.
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This issue is sponsored by folks that sell stuff their customers honestly want to keep a secret.
If you knew what they know, you would know you can change the way you store your cells. You wouldn't be thinking the yield you're getting from your cellular source material and cryopreserved products is just fine - not worth investigating. You would know that BioLife's solutions (now both the subject of an FDA Master File) could very well improve your product, decreased product failures, and maybe even lower your costs. But then if you knew that, you'd already be a customer!

You probably owe it to your cells to find out what they know.

www.biolifesolutions.com

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I want to take a moment to correct something. In December I said that while I was a little confused by their recent press release, it looked to my like Wuxi-Apptec was getting out of the cell therapy manufacturing business. I took the opportunity at last week's Phacilitate meeting to get some clarification. Indeed, I was wrong. I asked WuXi AppTec, VP, Philadelphia Operations, Garry B. Takle, Ph.D. for clarification. I'm happy to share with you his reponse below:

The recent closure of the recombinant protein and monoclonal antibody manufacturing bioreactor suites in the WuxiAppTec, Philadelphia facility does not affect the continued focus on and expansion of cell therapy manufacturing, cell bank manufacturing and biologics testing programs at the site. WuXiAppTec has taken the strategic position that cell therapy products are likely to provide significant outsourcing revenue in the short and mid term, as these more novel products become firmly established and better accepted.

WuXiAppTec has been in the cell therapy business for more than 3 years and intends to use the experience gained during this period to attract a broader portfolio of cell therapy clients. WuXiAppTec has so far completed 5 cell therapy manufacturing projects, including both allogeneic and autologous cell therapies.

In addition, WuXiAppTec currently performs testing for more than 15 cell therapy clients and manufactures more than 50 cell banks per year. Combined with considerable experience in medical device testing and manufacture, and in the production of tissue-based products at the WuXiAppTec St Paul facility, the WuXiAppTec Philadelphia site provides the GMP/GTP cell expansion expertise to develop and manufacture a wide range of cellular therapies and combination products.

FINANCIAL

Cell therapy company Garnet Biotherapeutics, developing products for scar reduction after surgery or dermatological procedures, announced the close of a $10.4 million round led by SCP Vitalife Partners II, L.P. Garnet will use the proceeds to fund Phase II clinical trials of its proprietary human adult bone marrow-derived cells, as well as manufacturing and development. Safeguard Scientifics, Inc. and Alliance Technology Ventures also participated in the financing.

It is clearly too early to do the 3-count for Bioheart, Inc. (Nasdaq:BHRT) which announced private funding commitments of up to $7 Million. The company has entered into a non-binding letter of intent with Organic Business Alliances, LLC ("Organic") pursuant to which it would invest approximately $1.5 million in Bioheart under its current offering under Regulation D and, subject to Bioheart achieving certain specified milestones, invest up to an additional $5.5 million on terms substantially the same as those of the offering. The investment by Organic is subject to approval of the boards of directors of both Bioheart and Organic and mutually acceptable definitive agreements.

Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced that on January 29, 2009, the Company entered into definitive agreements to sell restricted common stock and warrants for aggregate gross proceeds of $1,200,000.

The company also recently announced that it had received approval (in the form of a declaration) from Biotec Services International Limited, stating that Pluristem's Investigational Medicinal Product (IMP), PLX-PAD, is manufactured in accordance with standards of Good Manufacturing Practice (GMP), equivalent to those applied in the EU. Biotec Services is an international clinical trials supply company providing release services of the IMP into the European Union by a Qualified Person (QP). Upon IND and IMPD clearance by the regulatory authorities, Pluristem plans to initiate clinical trials in Europe and in the U.S.A., administering PLX-PAD to patients afflicted with critical limb ischemia, which has not responded to traditional medical or surgical interventions. They've invested ~$2M building in their facility and team to get them to the point of a successful audit of the manufacturing site by a Qualified Person. <more>

Following the implementation of the Clinical Trials Directive 2001/20/ EC in May 2004, any company wishing to undertake European clinical studies must have a Qualified Person (QP) release supplies of Investigational Medicinal Product (IMP) that have been manufactured outside the EU for use in European clinical studies. The QP conducts audits of manufacturing facilities outside the EU, ensuring that each batch has been manufactured in accordance with current Good Manufacturing Practices (cGMP) guidelines.

Organogenesis, Inc has been awareded a two-year, $7.4 million grant from the Massachusetts Life Sciences Center to support the firm’s expansion in the state. Organogenesis, a Canton, MA-based maker of living cell therapies for damaged tissues, has purchased two buildings in Canton and plans to grow its Massachusetts workforce from 220 today to 500 workers, according to the Life Sciences Center. Apligraf® has been used to treat many thousands of patients and is covered extensively by Medicare, Medicaid and by 350 private payers in the U.S.

According to their recently filed Form 10-Q (Quarterly Report), Aastrom Biosciences (Nasdaq:ASTM) executed a $15 million common stock purchase program with Fusion Capital Fund II, LLC (Fusion Capital) on October 27, 2008. They have the right, over a 25-month period, to sell shares of common stock to Fusion Capital from time to time in amounts between $60,000 and $2 million, up to an aggregate of $15 million, when they choose to do so, based on the terms of the agreement.

In an accompanying press release, Aastrom outlined a number of recent and anticipated events including the fact the FDA put their dilated cardiomyopathy (DCM) trial on hold Feb 2 for reasons which appear associated with the anesthesia administration.

ThermoGenesis Corp. (NASDAQ: KOOL) has reported second quarter results in whixh the company records the second quarterly sequential increase of 36%. For the quarter ended December 31, 2008, the Company reported revenues of $6.1 million, a 12 percent increase over revenues of $5.5 million in the same period a year ago. Disposable revenues in the quarter were $3.5 million, a 35 percent increase over disposable revenues of $2.6 million in the second quarter of fiscal 2008. Disposable revenues associated with the Company’s core AXP AutoXpress Platform™ (AXP™) and BioArchive® Systems offering increased by 56 percent year-over-year as AXP bag set volume in the quarter was 26,500 versus 20,000 in the second quarter a year ago.

The ThermoGenesis' MarrowXpress (MXP) is now being used to concentrate stem cells from bone marrow in an ongoing Phase II clinical trial being conducted at the University of Naples in Italy to study the effect of bone marrrow derived mononuclear cells on patients with critical limb ischemia (CLI). <more> <analysis>

Millipore Corporation (NYSE: MIL), a provider of technologies, tools and services for the global life science industry, announced that it has entered into a $22M agreement to acquire Guava Technologies, a provider of bench top cell analysis systems. The acquisition follows the distribution and co-development partnership the two companies announced in March 2008. Millipore says that its recently announced deal to acquire Guava Technologies will let it develop new kits for stem cell research. <more>

BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer and marketer of proprietary GMP hypothermic storage and cryopreservation media products for cells, tissues, and organs, announced record revenue and new funding to support internal manufacturing scale-up already underway to support increased product demand. The company registered record revenue for the fourth quarter and full year 2008. Preliminary fourth quarter 2008 revenue was $417,818, an increase of 36 percent from the third quarter of 2008, and 40 percent over the fourth quarter of 2007. This includes initial orders from nearly 30 new customers. Preliminary full year 2008 revenue was $1,326,772, an increase of 36 percent over 2007 fiscal year revenue.

Biolife also landed $1.4 million in credit funding from two shareleholders for operations and the completion of construction and validation of a new manufacturing facility.

To complete its triage of announcments, the company announced the launch of its new quarterly newsletter BioPreservation Today. They hope the publication will be a forum for sharing knowledge about optimizing biopreservation protocols and processes, to maximize the yield and function of cells and tissues in research and clinical applications.

Healthcare of Today, Inc ("Healthcare of Today"), announced the $100M acquisition of Regenetech, Inc ("Regenetech"). The Regenetech acquisition is one of a series of major acquisitions made by the holding company recently. Last week Healthcare of Today announced that it had obtained Advanced Developers, a builder of resort-like senior facilities in production in Florida and South Carolina. Prior to that, the organization had entered into an agreement to acquire another $19.4M medical facility in Agoura Hills, California.

Healthcare of Today, formed in May of 2008, is a holding company focused on acquiring and developing companies primarily within the healthcare industry. Through its subsidiaries, Healthcare of Today owns a variety of businesses including: nurse staffing, insurance, pharmaceuticals, residential care facilities for the elderly, assisted living facilities, skilled nursing facilities, senior communities, home healthcare services, senior fitness, real estate brokerage/relocation services, adult daycare, a private chef network, a culinary institute, healthcare information technology, nurse education, and biotechnology.

Regenetech® has concentrated its research efforts on development of umbilical cord blood and peripheral blood expansion, increased regeneration of bone for orthopedic uses, and production of biomolecules. Regenetech®’s business purpose is to commercialize adult stem cell expansion technology by developing stem cell and tissue regeneration technology, patenting it quickly and either licensing or establishing joint ventures to commercialize the technology to generate revenue.

Last year Regenetech announced it could achieve a 60-fold increase of adult stem cells through its cellXpansion™ process, namely CD34+38- peripheral blood progenitor cells (adult stem cells). These results were reportedly achieved through the continued development of cell culture conditions in Regenetech’s proprietary and patented Intrifuge™ cellXpansion™ technology. As I recall from listening to a presentation last May, the core technology is essentialy an electro-magnetic field placed around a bioreactor.

The company was founded in April of 2002 as BioCell Innovations. In May of 2002 the company acquired its original patent licensing rights through a novation from NASA. In May of 2002 Regenetech® entered into a Sponsored Research Agreement with M.D. Anderson Cancer Center in Houston, Texas. Regenetech® filed its first patents in August 2002. The company name was changed to Regenetech®, Inc. in November of 2002 in order to begin developing trade name value. Stage 1 research was fully completed in January 2003. Regenetech® licensed its first intellectual property for treatment of Sickle Cell Anemia. In April 2004 Regenetech® Licensed an additional two (2) patents from NASA relating to advanced bioreactor technology.
In April 2004 Regenetech® entered into a Reimbursable Space Act Agreement with NASA to continue development of adult stem cell expansion. In January 2005 Regenetech® confirmed its significantly expanded adult stem cells were free from cancer risks and had no genetic modification. In 2005-2006, Regenetech® expanded its research at NASA and several universities and completed the filing of its first73 patent applications.

The company's former CEO Dr. David Bonner, who appeared at one point to be steering the business toward involvement with off-shore commercial stem cell transplant clinics, had a parting of ways with the company a year or so. He then opened up Stematix, Inc with some of his former team. Stematix is in business to "support and establish fully operational stem cell banks and therapy clinics around the world."

Intercytex Group plc (LSE: ICX) ("Intercytex" or "the Company"), a developer of regenerative medicine products, has implemented restructuring actions to reduce cash burn. Despite the very positive progress being made on all projects, with the financial markets in their current state, the Company will shortly commence a 30 day consultation period with employee representatives proposing a reduction in headcount at the Company's facilities in Manchester UK and Boston, USA of around 50% from the current level of 76 employees. The reduction in workforce will extend the Company's existing cash resources to fund operations until around the end of 2009. The measures are expected to be implemented with effect from March 2009.

CLINICAL

Advanced Cell Technology, Inc. (OTC:ACTC) provided a corporate update in which it announced that it has accelerated its efforts to file an IND for its retinal pigment epithelium (RPE) cells program for the treatment of diseases of the eye in light of today’s decision by the U.S. Food and Drug Administration to grant clearance for a stem cell company to begin trials for the world's first study of a human embryonic stem cell-based therapy for people. The Company is close to securing the necessary funding which would allow it to make the requisite filings during the summer of this year

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that its collaborators at the University of Pennsylvania (Carl June) have opened a Phase 1 clinical trial to evaluate SB-728-T for the treatment of HIV/AIDS. SB-728-T is produced by specifically modify the patient's own CD4+ T-cells, the principal target of HIV infection, with a one-time exposure of the cells to CCR5-specific ZFNs. This generates a population of T-cells that lack the CCR5 receptor, are resistant to HIV and can be infused back into the patient to provide a reservoir of HIV-resistant functional immune cells and, more importantly, may expand and provide an HIV immune response. specifically modify the patient's own CD4+ T-cells, the principal target of HIV infection, with a one-time exposure of the cells to CCR5-specific ZFNs. This generates a population of T-cells that lack the CCR5 receptor, are resistant to HIV and can be infused back into the patient to provide a reservoir of HIV-resistant functional immune cells and, more importantly, may expand and provide an HIV immune response." The primary objective of the study is to evaluate the safety and tolerability of SB-728-T. In addition to safety monitoring, data will be collected on the expansion and persistence of ZFN-modified cells, CD4+ cell counts and viral load.

According to a online publication in Molecular Therapy, Stratatech Corporation has engineered a skin substitute with potent anti-infective function. The product is a genetically modified version of its StrataGraft® living human skin substitute designed to actively fight costly bacterial infections that routinely develop at the site of burns and other severe skin injuries, such as skin ulcers. Stratatech’s skin-substitute innovation reportedly enables the immediate topical delivery of a potent anti-infective that actively inhibits bacterial growth and promotes regrowth of the patient’s own cells. The anti-infective capacity of Stratatech’s genetically-engineered tissue, which is being developed and commercialized by the company as ExpressGraft™ Enhance skin substitute was generated using a non-viral vector, or carrier. The company believes it is the first time a virus-free approach has been used to genetically modify a living, cell-based tissue substitute

Therakos, Inc. announced that Health Canada has cleared the THERAKOS(TM) CELLEX(TM) Photopheresis System for the palliative (reducing the severity of symptoms) treatment of the skin manifestations (appearance) of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment.

Stem Cell Innovations, Inc. (OTC Pink Sheets: SCLL) appears to be working on a liver assist device to support patients waiting for transplant. The company has not made a formal announcement that I can find and the company's website is woefully out-of-date but the device was described in a paper published in the most recent issue of Current Gastroenterology Reports. Medical News Today was able to get the company to comment for an article they did highlighting the article: "There are currently three times as many patients on the waiting list for liver transplantation as there are organs available and few ways to stabilize them if they enter an acute phase of their disease," said Kelly, CEO of Stem Cell Innovations. This second generation device, based on the PluriCells, "combines the safety of primary hepatocytes (normal liver cells) with the standardization of a cell line," continued Kelly. "We're building on what we learned from our earlier device which utilizes the C3A cells that form the basis of Stem Cell Innovations' ACTIVTox(R) drug discovery products. We are one of the few companies that can approach this problem from both sides: from the stem cell and from the adult liver cell. We are using our PluriCell(TM) system to understand the requirements of the liver stem cell and our ACTIVTox system to understand the requirements of the mature cell."

COMMERCIAL

Privately held SkinMedica of Carlsbad says it has filed a patent infringement lawsuit against new San Diego startup Histogen and Gail Naughton, its founder and CEO. The lawsuit, which was filed in federal court in San Diego, alleges that Histogen and its affiliated Histogen Aesthetics business infringe on two SkinMedica patents related to proprietary conditioned cell media technology. SkinMedica says its complaint asks for unspecified relief for the “misapprorpiration of SkinMedica trade secrets and confidential information by Histogen.”

International Stem Cell Corporation (OTCBB: ISCO) continued its recent publicity campaign with a letter to shareholders outlining recent development and plans for the company and their human parthenogenetic stem cells. The company is thrilled to have had their name dropped in a recent article in the Economist along with corporate pioneers like Geron & ACT.

Neuralstem Inc. (AMEX: CUR) has nailed down a key patent for its core technology, which grows neural stem cells from the brain to replace damaged spinal cord cells. The patent comes in time for Neuralstem’s first clinical trials, planned for this year if the Food and Drug Administration gives them the green light. The Rockville company intends to test the ability and safety of injecting fetal stem cells into the spinal cords of patients suffering from amyotrophic lateral sclerosis, more commonly known as Lou Gehrig’s Disease. Neuralstem filed its request in December to launch its first human clinical trials this spring. It expects to hear the FDA’s decision by the middle of next month, but another competitor’s recent news has raised its hopes.

Bio-Matrix Scientific Group (OTCBB: BMSN) (www.BMSN.us) has entered into a cell processing and storage contract with both NeoCells, Inc. and AdultCells, Inc. (ACI; www.adultcells.com). Pursuant to this Contract, BMSN has agreed to (a) cryogenic banking and processing of umbilical cord blood and adult peripheral blood stem cells of clients from both NCI and ACI and (b) cryogenic banking and processing of menstrual blood and other human stem cells of clients from both NCI and ACI upon BMSN’s approval. Fred Fitzsimmons, CEO of NeoCells, Inc. and AdultCells, Inc., envisions “the developing relationship between BMSN, NCI and ACI leading to the establishment of the premier stem cell cryogenic storage company in the U.S.” he said.

RESOURCES & EVENTS

Ex-FDA regulatory consultant Darin Weber (aka "Regenerative Medicine Guru") now of the Biologics Consulting Group, has posted on his blog a number of useful presentations and articles he did in 2008. It's worth checking out.

You won't find a press release about this anywhere but the only weekly publication dedicated to news in the cell therapy sector, Cell Therapy News (which I founded back in 2001 as an email to colleagues and grew to ~11,000 subscribers) has now been subsumed by the Stem Cell Technologies' marketing department. The publication is no longer accepting outside advertising. Cell Therapy News is a news amalgamation service and does not do original and/or editorial content. The publication's objectivity should not be compromised unless they refuse to include press releases from competitors. Rumor has it this is indeed the case. Disappointing if true.

If you're interested in getting into the mind of Stem Cell Technologies' owner and founder, Allen C. Eaves, you'll find the rambling interview of him recently posted by Q1 to be an interesting read.

Monya Baker from The Niche, always does such a nice job of collecting primary and divergent sources on a topic. She's done the same on her second post about Geron. If this is a trial, company, or stock in which you are particularly interested, you'll want to check out her collection of articles.

This past week's GEN podcast was "Stem Cell Therapies on the Rise" by Linda Powers, Cofounder and Managing Director of Toucan Capital, which has 16 stem cell or regenerative medicine companies in its portfolio. Linda specifically addresses the issue of how the FDA's decision on Geron's IND might boost the development of stem cell therapies and speculates on what may have influenced the agency's decision to give Geron the go-ahead for a trial at this time. Powers also discusses why all the attention on human embryonic stem cell research has given short shrift to work with human adult stem cells and provides specific examples of the successful application of adult stem cells to treat human diseases. Powers describes what's needed from the financial, political, regulatory, and public acceptance arenas to make stem cell and regenerative medicine part of an expanded armentarium of therapeutic approaches in applied and clinical medicine. She also explains why the establishment of a biomanufacturing industry for the production and processing of stem cells and other living cells could give rise to a new and significant business segment of the American economy.

NIH/NHLBI and PACT have announced a workshop on 23-24 April entitled "Converging Concepts in Cell Therapy". This workshop will be held at the National Institutes of Health (NIH), Natcher Conference Center in Bethesda, Maryland.

University of Minnesota is hosting a professional short course, "Preservation of cells, tissues and gametes" to be held May 18-20, 2009.

Sign-off...

I was very pleased to see a 1.5-page article entitled "Stem cell alliance" in the January 2009 issue of R&D Directions magazine, a very pharma-focused publication related to 'pharmaceutical research and development'. The >$1B deal Genzyme-Osiris deal has caught the attention of many in the pharma sector who heretofore have believed the sector too immature to mean real business.

That ends a hectic two-weeks. Sometimes conferences and paying work get in the way of blogging. I can't really complain. But that's why this is later than my usual Friday pub date. I have every intent to get back to the weekly schedule on Friday. We've had a good run of new subscribers sign up this week. Welcome ya'll. If you learn anything here we hope it's that cell therapy...means business! :)