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 2009-04-10

Here we are in April 2009. The much newly anticipated date when we expect the Dendreon saga to head toward a climax. Few people know the Dendreon story better then Xconomy journalist, Luke Timmerman who does an outstanding job of summarizing the saga and stakes in Dendreon's immiment Provenge gamble. Indeed tomorrow is the beginning of what we now anticipate will be the final chapter in this epic sage. Tomorrow (at 9am EDT), Dendreon will discuss the final results from their phase III IMPACT trial of Provenge for prostate cancer (call details here).

Here are a couple random bits to kick us off:

• According to a recent statement by the high-profile VC Steve Burrill, $5M in VC money used to buy 30-50% of a company; now it buys 90%.

• GEN's editor in chief, John Sterling has included "Stem Cells: Translating Exciting Preclinical Data into Human Clinical Trials (Translational Medicine)" as one of his top-10 session picks for the upcoming 2009 BIO International Convention.

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Not settling with organizing doctors against the FDA with his "American Stem Cell Therapy Association (ASCTA)" (see my previous blog comments), Dr. Christopher "the renegade" Centeno is now inciting patients to oppose the "FDA's position that the patient's own adult stem cells are drugs and should be regulated as such." (Click here for the press release.)

To facilitate patient activism he has launched a patient web-site, safestemcells.org, to drive the activities and opinions of patients in what he's calling the Safe Stem Cells NOW! movement. The Stem Cells Now! movement's goal? "To inform patients and physicians that their ability to access safe stem cell treatment is being heavily restricted by pharmaceutical industry agendas and by the FDA."

He has also recruited the enthusiasm of Barbara Hanson, co-founder of stemcellpioneers.com, who is quoted as saying:

"Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."

For my other posts about the work of Dr. Centeno, see Regenexx vs the FDA 2009 and Cell therapy is not the practice of medicine.

FINANCIAL

Some people I talk to in the sector say they feel weirdly immune from the entire economic meltdown because the industry seems to be ticking along just fine in many ways continuing to be fueled by its own internal optimism and external enthusiasm for the promise of cell-based therapies...well that, and the still-growing amount of money being spent on the research side of the sector. Others, are certainly feeling the pinch. The dividing line may well be those who are trying to raise money and those who are not.

Having said that, here we go with reports of money being raised -- all from non-US investors mind you. Proving that its economy is not down and out, the first two report of fundraises come from Down Under.

There's no way I can start this first story any better then The Australian did in its March 12 report (that I only now just picked up now): "From the miracles-do-happen file comes this provident yarn of a $3.4 million market cap tiddler that has secured $12 million of funding for further development of its ovarian cancer drug, CVac."

They're talking, of course, about Prima BioMed Limited (ASX:PRR) which has been busy reinventing itself with new management and money since Biomira took a pass on its option to partner on CVac development more than a year ago. The company has been slowly bleeding money and management since. The company is still clearly on a low burn because I had to mine this information from anywhere but direct sources. The company itself has been very quiet about any of this.

The news is this: Prima Biomed has secured access to a $12-million funding facility from investment bank Fortrend Securities to help commercialize the company’s ovarian cancer treatment. The deal allows Prima to place shares with Fortrend as needed over the next three years.

Prima said it will use the cash to move through a phase IIb trial and towards a pivotal US registration trial of its dendritic cell-based ovarian cancer therapy, which the company says is designed to stimulate the body’s own immune system to attack cancer cells. The company said it now hopes to begin a US trial by mid-year, after the company reported positive feedback on its pre-investigational new drug meeting with the US Food and Drug Administration last year.

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Not to be outdone by the magic tricks of its pennystock sibling, the much more stable Mesoblast Limited (ASX: MSB) which reported on 31 December 2008 having $9.6 million of capital at its disposal announced that it has successfully raised an additional $10.81 million by completing a private placement to existing, as well as new, institutional and sophisticated investors. The new funds will be used to expand the company’s clinical trial programs focusing on bone and cartilage regenerative products for spinal vertebral disc disease. These programs will be pursued in parallel to the Company’s ongoing Phase 2 clinical trial in knee osteoarthritis. The placement of 15.02 million shares was reportedly oversubscribed and was made at a 10% discount to the closing price of the Company’s shares on 25 March 2009.

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NeoStem, Inc. (Amex: NBS) reports they have completed an $11 Million series D private placement financing from three Asia-based investors, including a private equity firm operating in partnership with strategic investors. Investors are RimAsia Capital Partners, LP, a pan-Asia private equity firm operating in partnership with a regional network of strategic investors drawn from leading Asian families and companies, investing $5 million; Enhance Biomedical Holding Corporation based in Shanghai, and investing $5 million and Elancrest Investments Ltd., a Singapore-based firm, investing $1 million.

While NeoStem makes mention of using the funds in various ways including the development of its VSEL (very small embryonic-like stem cells) technology licensed from the University of Louisville, what they really seem focused on is expansion activities in China, including those relating to its pending acquisitions and medical tourism - defined as travel by people whose primary and explicit purpose is to access in a foreign country medical treatment not yet available in their own nation.

NeoStem expects to connect U.S. citizens with advanced therapies not yet available in the U.S., and attract people from other countries to seek regenerative therapies in China. Indeed Eric Wei, Managing Partner of RimAsia Capital Partners, LP is quoted as saying, "We are extremely optimistic about the growth opportunities for NeoStem based on its multi-pronged plan to capitalize on a growing PRC-based network. We are glad to be joined by other investors in Asia who recognize the huge market potential for stem cell therapies in the PRC [People's Republic of China], a field in which breakthroughs are developing at an accelerating rate."

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In a UK report about how stem cell innovation is at risk, the study authors from The University of Nottingham, funded by the Engineering and Physical Sciences Research Council (EPSRC), reports that the global cell therapy industry, reports that the global cell therapy industry:

"...now involves nearly 200 companies developing primary and secondary cell therapies, plus another 180 banking cord blood. In total the global cell therapy industry currently has sales of over $1 billion a year and a steady number of products are now reaching late stage clinical trials."

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Crystal Research Associates, LLC has issued an Executive Informational Overview® (EIO®) on Neuralstem, Inc. (CUR: NYSE-Alt)

CLINICAL

Amorcyte, Inc recently presented data at the American College of Cardiology (ACC) Annual Scientific Session from its Phase I clinical trial of AMR-001, the company's lead product for the treatment of damaged heart muscle following acute myocardial infarction (AMI), that showed a significant relationship between cell dose and biologic effect. According to the company this is the first and only study to prospectively define a dose of a purified and potent autologous stem cell therapy (AMR-001) that resulted in a significant improvement in perfusion, a trend towards improved cardiac function and the potential to reduce subsequent adverse cardiac events following AMI. Emory University - one of the study sites - also issued its own press release on the data.

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At the same meeting, TCA Cellular Therapy’s Medical Director Gabriel Lasala, M.D. presented preliminary results of an adult stem cell treatment for severe limb ischemia from its Phase I safety/efficacy clinical trial using a combination of the patient’s own endothelial progenitor cells (EPCs) and mesenchymyal stem cells (MSCs) obtained through bone marrow aspiration then mixed and infused into damaged veins.

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MolMed S.p.A. (MLM.MI) announced that results obtained in the European multicentric Phase I/II study (TK007) of its TK therapy have been published in the April issue of the prestigious medical journal The Lancet Oncology. The article - Infusion of suicide gene-engineered donor lymphocytes after family haploidentical hemopoietic transplantation for leukemia: the TK007 phase I/II trial - gives insight into the outcome of the trial, conducted on 54 adult patients, that resulted in significant survival improvement of patients affected by high risk acute leukaemia receiving bone marrow transplants from a partially compatible family donor (haplo-transplants). In this context, the introduction of TK therapy allows the use of add-backs of donor T lymphocytes, that promote a rapid and wide immune reconstitution, abating transplant-related mortality and permitting long-term survival.

These trial results were, of course, already communicated to the market and included in MolMed’s Offering Circular and allowed MolMed to get authorisation to begin a Phase III randomised trial that started in Italy in Spring 2008, and will be expanded to other European clinical centres this year. The Phase III trial TK008 is pivotal for the registration of TK therapy, that could become among the very first cell therapies using genetically engineered cells to obtain marketing approval. MolMed’s partner for the Asian markets, Takara Bio Inc. (OTCPK:TKBIF), started clinical development of TK in Japan in October 2008, with a Phase I trial in relapsed leukaemia patients conducted at the National Cancer Center in Tokyo.

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These breasts and slim waist are brought to you by Cytori Therapeutics, Inc. (NASDAQ: CYTX) and GE Healthcare. Available soon to women for only £6,500?

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While Prima BioMed has been closing the deal on its new financing it has also apparently obtained permission from the Australian TGA's Special Access to treat a patient with its CVac ovarian cancer treatment. The injection of the vaccine in ovarian cancer patients works as a postsurgery and post-chemotherapy maintenance therapy to delay relapse and control metastases. While the company is currently not in clinical trial in Australia and has not yet filed its IND for FDA approval in the U.S., the company has sought special exemption for a single-use treatment for what must be a very special patient.

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Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced the treatment of the first patient in a Phase II clinical trial evaluating Prochymal for the treatment of heart attacks.

COMMERCIAL

Further to my speculative post here last week, we've now learned that ULURU Inc. (NYSE Amex: ULU) has signed a non-binding offer letter to acquire York Pharma plc ("York"). York Pharma is a United Kingdom based skin care company with operations or distribution networks throughout Europe with an established revenue base. By way of reminder, the reason this is of interest here is that York has two cell therapy products on the UK market for the treatment of chronic wounds and burns: Myskin™ and Cryoskin™.

While the companies have not yet executed definitive documentation relating to any acquisition transaction and there's no guarantee they will, Uluru is hoping potential benefits will significantly accelerate the maturation of ULURU into a commercially based company with a strong revenue base and positively position the company for more rapid growth both in the United States and Europe.ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers with improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex(TM) Aggregate technology and transmucosal delivery system

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Novocell, Inc. announced that it has received U.S. Patent 7,510,876 with claims covering human definitive endoderm cells, an essential cell for generating not only pancreatic type cells, which Novocell is developing for use as a cell therapy for diabetes, but also other endoderm lineage-derived tissues and organs such as lungs, intestine, liver, thymus and thyroid.

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Progenitor Cell Therapy LLC board member Robert A. Hamm promoted as COO of drug maker Biogen Idec.

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Looks like WuXi PharmaTech Incorporated has some serious buyer's remorse of it $162.7 million purchase of AppTec Laboratory Services Inc.

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Advanced Cell Technology, Inc. (OTCBB: ACTC.PK) could receive up to $1.9 million in fees as a result of a new licensing agreement with its Korean partner. ACT has agreed to license certain retinal pigment stem cell technology to CHA Bio & Diostech Co. Ltd. for development and commercialization exclusively in Korea. The two companies have a recently formed joint venture called "Stem Cell & Regenerative Medicine International" located in Worcester, MA and focused on the development of human blood cells. It is majority owned by CHA Bio and benefits from ACT exclusively licensing all of its hemangioblast technology to the joint venture.

If all milestones are met in this new collaboration focused on stem cell technology to treat a variety of eye diseases, ACT stands to earn $1.9 million in fees. CHA will pay all fees associated with clinical trials expected to take place in Korea. Meanwhile, ACT has applied to the U.S. Food and Drug Administration to begin clinical testing of its retinal pigment stem cell technology during the second half of the year.

*

Presumably to help soften the financial blow of its interrupted phase III trial of Prochymal for Crohn's disease, Osiris Therapeutics, Inc. (NASDAQ:OSIR) has announced that it has agreed with NuVasive, Inc. (NASDAQ:NUVA) to accelerate transfer of the Osteocel business. Under the terms of amendments to the existing agreements between the parties, NuVasive will assume responsibility for Osteocel processing by April 10, 2009 and has removed contingencies applicable to $30 million of the $45 million in remaining milestone payments.

Osiris is now scheduled to receive $30 million in cash or NuVasive common stock in 3 schedule payments all before the end of September. The terms applicable to the remaining $15 million milestone payment are unchanged. This additional payment becomes due and payable when NuVasive achieves $35 million in cumulative Osteocel sales. NuVasis has projected $29 million in Osteocel sales in 2009.

To date Osiris has received from NuVasive $40 million in upfront and milestone payments. Effective April 10, Osiris will cease all operations associated with Osteocel processing. Concurrent with the amendments to the Asset Purchase and Manufacturing agreements, Osiris will transfer its Osteocel inventory to AlloSource, of Centennial, Co., which had been processing quantities of Osteocel for Osiris and has now agreed to produce Osteocel solely for NuVasive. NuVasive has entered into a separate outsourcing supply agreement with AlloSource for the continued manufacture of Osteocel.

Because of that deal, they are now able to layoff 80 people.

*

It looks like the ever well-tanned Burton Feinerman is back in control of his company Stem Cell Biotherapy which he at least appeared to lose temporarily to his former partner Casey Nabavi until Nabavi abandoned ship late last year to start a competing stemcell transplant company, Cellulogix. Now it looks like things are going to bet rough between the former partners. Stem Cell Biotherapy ("SCB") has filed suit in Los Angeles County Superior Court against the Company's Co-Founder and former President Casey Nabavi of Calabasas, California, for among other things conduct by Nabavi giving rise to patient claims against Nabavi that he had misrepresented himself as a medical doctor, practiced medicine without a license, supervised the injection of stem cells which caused some patients to become ill and personally advised patients how to manage these side effects. Nabavi/Cellulogix have offices/clinics in Los Angeles, Tampa, Montreal, Zona Rio (Mexico) and Istanbul. The SCB lawsuit also seeks to recover SCB funds in excess of $1.65 million that Navabi paid himself before leaving SCB, to recover assets including intellectual property belonging to SCB which Navabi took and used to start-up the new Cellulogix business, to prevent Nabavi from continuing to compete with SCB in contravention of the parties' non-competition agreement and for SCB to recover ownership, the business and profits of Cellulogix as belonging to SCB not to Navabi as a result of Nabavi's wrongful conduct and activities. A copy of the SCB lawsuit against Nabavi and Cellulogix can be viewed at the Company's web site www.stemcellbiotherapy.com.

SCB is in the business of "assisting persons who desire to try stem cell therapy treatment for serious medical problems which have not responded to traditional medical treatments." SCB uses medical clinics and specialized doctors in locations around the world where stem cell therapy is authorized to treat medical conditions such as spinal cord injury, ALS, Parkinsonism, Alzheimer's, multiple sclerosis, autism, cerebral palsy, brain damage, heart disease, COPD, kidney diseases, eye diseases, diabetes, transverse myelitis, etc.

*

Adding themselves to the growing list of companies looking to leverage their cell-based technologies to get to market early with some type of non-therapeutic low-hanging fuit in order to finance their more serious, therpeutic product development aspirations, Stem Cell Therapy International Inc. (OTCBB: SCII) -- soon to be known as AmStem International after a successful merger with Histostem Ltd, of South Korea -- has decided that its first product will be a "cosmetic face cream made with stem cells" to be sold wholesale to major cosmetic distributors worldwide. This is expected to provide AmStem with an influx of capital to finance "expansion in other areas".

*

Proving there may never be an end to the types of stem cell banking models that continue to pop up, StemSave™, Inc. is now encouraging dental patients to bite on their offer to bank stem cells collected from their disposed teeth. StemSave’s patented technology turns routine trips to the dentist into "potentially life-saving experiences".

So we can now pay to save our stem cells from our umbilical cord blood, umbilical cords, amniotic fluid, placenta, adipose (fat) tissue, menstrual blood, bone marrow, blood (after stem cell mobilization or not), and teeth. Hmmm.

RESOURCES, EVENTS & MISCELLANEA

Regenerative Medicine Vol. 4, No. 2, March 2009 is now available online.

*

Stem cell scientist Dr. Robert Lanza, Chief Scientific Officer of Advanced Cell Technology has managed to find time away from changing the world of science and modern medicine to pen a book with astronomer Bob Berman on Biocentrism , a subject that challenges our traditional, outdated perceptions on life, time & space, and even death.

*

The New York Academy of Sciences, China’s Ministry of Health, the Chinese Academy of Medical Sciences, the Chinese Academy of Sciences and international partners including the Medical Research Council of the UK and the German Research Foundation are collaborating to host a conference entitled ‘Regenerative Medicine’, May 15-16, 2009 in Beijing, China. The meeting is intended to foster collaborations between industry, academia, government, and finance with a world-renowned scientific organizing committee including Nobel Laureate Dr. Torsten Wiesel and the Chinese Minister of Health, Zhu Chen. The scientific program includes Drs. Anthony Atala, John Gearheart, and Stefanie Dimmeler, among many other leaders from industry, academia, and the clinic. A full conference agenda can be found at www.nyas.org/regmed

Sign-off

That's all I got.

Thanks again to lab equipment supplier, Next Advance, for supporting this issue of the Cell Therapy Industry Hilites. They found me on Twitter, you can too. I'm @celltherapy.

Cell Therapy Industry HiLites 2008-12-19

Ok so it's almost not Friday anymore even by my Pacific Time Zone but I promised to try to do this every Friday and so here I am. I will not be doing a HiLites next Friday however. I'm taking a break for the holidays.

For the week before Christmas this was one busy week!

I'll start this week's HiLites with a bit of a focus on Bioheart, Inc. (Nasdaq:BHRT). The company has been busy this week reinventing itself - just how much remains to be seen. As followers of the industry will recall, Bioheart had a disappointing IPO earlier in the year but was able to raise ~$1.8M in a private placement in October. This, I suspect, is not much more than survival money as they are financing a 330-patient phase II/III trial in US and Europe.

So the company's announcement this week came as no surprise that it intends intends o spin out or sell off its interest in several non-core technology platforms including:
- Biopace -- A biological pacemaker.
- MyoValve -- A cell seeding method for repairing and building biological heart valves.
- EndoCell -- A system for bedside preparation of adipose tissue for delivery of endothelial progenitor cells to the adventitia of coronary arteries for prevention of restenosis following
balloon angioplasty, stenting or atherectomy.
- AortaCel -- Cell compositions and delivery systems for repairing aortic aneurysms or for reinforcing the neck area in aortas repaired with an endovascular stent graft.

In addition, Bioheart is seeking a strategic partner for the development of its bi-ventricular pacemaker technology, called MyoStim, which utilizes a patented electrical stimulation software program and an additional pacemaker lead to enhance cell transplantation.

Understandably Bioheart is doing this in order to intensify its strategic focus on the treatment of patients suffering from heart failure. Interestingly, however, in their press release Bioheart made no mention of their cell therapy saying rather that Company is strategically focused on commercializing patented technologies for reducing and repairing heart muscle damage caused by heart attacks as well as marketing advanced heart failure monitoring devices including the Bioheart 3370 Heart Failure Monitor and the Bioheart-Monebo CardioBelt(tm) ECG Acquisition Device.

Then yesterday Bioheart announced it had had signed a deal with Life Technologies Corporation (Nasdaq:LIFE) (the new combined Invitrogen-Applied Biosystems entity) which provided Life the global distribution to Bioheart's myoblast cell-based research products to life science researchers. The deal is intended to "expand the number of therapeutic applications under development with this type of cell" but again no mention of Bioheart's own trial or product.

All of which leads to at least a couple questions we hope Bioheart will soon answer. Firstly, is the company positioning itself away from its lead product MyoCell®? Secondly, the deal with Life Technologies was described as a "distribution and OEM agreeement" but while there was discussion about the distribution aspects of the deal, there was no description of the OEM part. Given that neither company has any notable capacity or expertise in producing clinical-grade cells will this only encompass research-grade cells or are there other plans here not being discussed?

I'll move on to other news of the week.

In a move that will certainly enhance his legacy on his way out the door, Alan Lewis announced that Novocell, Inc. has entered into a non-exclusive drug discovery collaboration with Pfizer which gives Pfizer access to Novocell’s proprietary pancreatic progenitor cells derived from human embryonic stem (hES) cells. This appears to be an open-platform type of agreement (limited for now to 2 years). Novocell will receive an upfront payment, research funding, additional amounts payable upon the achievement of certain technical milestones, and payments relating to the sale by Pfizer of any exclusive therapeutic discovered as a result of the collaboration.

Novocell has shown it can coax human embryonic stem cells to become fully functioning pancreatic beta cells that secrete insulin in mice but about 15 percent of the animals got teratomas, a type of tumor. This, the company will have to learn to prevent or at least control before it gets approval to go to human clinical trials. For now, as Xconomy's Luke Timmerman says, "Novocell can take some comfort knowing that some of the deepest pockets in the pharmaceutical industry are shelling out at least a little spare change to help it crack daunting challenges like that."

BioLife Solutions Inc. (OTCBB: BLFS) announced that it has completed an initial series of small animal safety studies. The studies evaluated injections of HypoThermosol, CryoStor, or control phosphate buffered saline (PBS) into healthy rodents. The study was designed to mimic human clinical applications where stem cells isolated from cord or peripheral blood are re-suspended in a carrier solution and administered intravenously to treat patients suffering from a variety of diseases and disorders including leukemia, anemia, lymphoma, myeloma, and other cancers.
The results of these studies demonstrate- the Company claims - that infusion of HypoThermosol and CryoStor present no safety risk within the parameters of this two-stage evaluation in a rodent model. Data to be published and/or presented soon.

Avita Medical Ltd (ASX: AVH) says the French Ministry of Health is funding a 200 patient medico-economics study on the impact of Recell on burn wound healing. Avita said that the first patients were enrolled and had been treated in the study which was part of a French program “to advance the implementation of innovative technologies”. Avita said the primary goal was to demonstrate the medical effectiveness and economic benefits of the Recell technology to the hospital and health care system in the treatment of burns and wounds.

Recell, already commercially available in Australia, is a single-use medical device for harvesting autologous skin cells. Developed as an 'off the shelf' kit, ReCell enables a thin split thickness biopsy, taken at the time of procedure, to be processed into an immediate cell population for delivery onto the wound surface. Once processed, the cell suspension is available for immediate use and can cover a wound up to 80 times the area of the donor biopsy. ReCell enables the delivery of keratinocytes, melanocytes, fibroblasts and Langerhans cells harvested from the epidermal-dermal junction for application onto a wound surface in order to promote effective wound healing.

Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) filed a European Investigational Medicinal Product Dossier (IMPD) to begin clinical trials of its placental-derived adherent stromal cell product, PLX - PAD, an allogeneic cell therapy, for critical limb ischemia. The company filed the IMPD application with the Paul Ehrlich Institute (PEI), the German competent authority in the European Union (EU). An IMPD is a harmonized procedure for the authorization to perform a clinical study in any one of the EU Member States. An IMPD is requested whenever the performance of a clinical study in any one of the EU Member States is intended, and it is similar to an Investigational New Drug (IND) Application that would be filed for the performance of a clinical study in the United States. Assuming approval of the IMPD by this authority, Pluristem said it plans to initiate the dose ranging clinical trial during the second quarter of 2009 at two sites in Berlin, Germany

Amgen lobbied this week for personalized medicine by presenting to the FDA the argument that one of its drugs should be used by just a subgroup of patients with colorectal cancer who appear to be most likely to benefit from it.

NeuralStem filed an IND to use its neural stem cell technology in a trial for Lou Gehrig’s disease in what it described as the first ALS trial using stem cells.

Progenitor Cell Therapy has brought in a new CFO with over 21 years of experience in the life sciences industry and fundraising. This will undoubtedly help them raise the funds needed for their continued US and European expansion plans.

StemCells, Inc (NASDAQ: STEM), which already has a trial underway for Batten disease, just received FDA approval to start a trial for Pelizaeus-Merzbacher Disease (PMD), also fatal brain disorder that affects mainly young children. The mechanism of the potential Batten disease therapy is to establish healthy neural cells that can help a patient’s own cells clear out some toxic garbage that builds up in the disease, the mechanism for PMD is to boost myelinization of neurons. StemCells uses cells originally derived from fetal tissue.

Although this news will be old to some I discovered this week Arteriocyte's announcement from November 10 that it had been awarded the DARPA Blood Pharming award to the tune of $1,950,000 which presumably it has to share with collaborators at Johns Hopkins University, The Ohio State University and INSERM, Paris. While this seems like a sizeably juicy award, the US Military's Defense Advanced Research Projects Agency (DARPA) has issued a tall order. DARPA wants a self-contained device small enough (≤47 ft3) to go into the military field and create at least 100 units of universal blood (i.e., can be transfused into anyone regardless of blood type) per week for eight weeks. The key ingredient to Arteriocyte's proposal and the company's Nanofiber Based System (NANEX) technology is umbilical cord blood stem cells.

While technically not a cell therapy play, both these players are notable enough in the cell-as-tools sector that we thought it worth noting that VistaGen Therapeutics has signed a deal with Wisconsin Alumni Research Foundation (WARF) to license WARF's human embryonic stem cell patents for the development and commercialization of stem cell-based research tools.

Winning this week's award for the press release with no news, is the annoucement from Advanced Cell Technology, Inc.(Other OTC: ACTC.PK) that "its technology platform, which utilizes a single cell biopsy that does not destroy the embryo, is well positioned to receive Federal funding under the new administration led by President-Elect Barrack Obama."

They made up for it the next day, however, by releasing news of new funding. Demonstrating, once again, their tenacious survivability, ACT announced it had licensed a "non-core technology" to one of its creditors, Ireland-based Transition Holdings, Inc, for $2.5 million - comprised of the extinguishment of $1.5 million of debt and an additional funding commitment of $1 million. The Company expects to apply the proceeds it receives in the future towards its retinal pigment epithelium (RPE) cells program.

Cytori has now launched a a 30-person clinical trial using adipose (fat) stem cells for chronic radiation induced injury.

Life Technologies announced its CIRM award will be used to develop human stem cell models of neurodegenerative diseases to advance drug development. The company intends to use human embryonic stem cells to develop new models of Lou Gehrig's Disease and other neurodegenerative diseases.

Inno Bio Diagnostics Sdn Bhd (IBD), which specialises in cell-based diagnostics and regenerative medicine, is investing RM4.58 million (~$1.3M) to set up a cell therapy centre at the Universiti Kebangsaan Malaysia Medical Centre (UKMMC) in Kuala Lumpur, Malaysia. IBD, a wholly-owned subsidiary of Inno Bio Ventures Sdn Bhd, aims to create and develop business opportunities in stem cell technology in the area of cell-based diagnostics and therapy. The cell therapy centre, which is expected to start operations next year, will be jointly managed by IBD and UKMMC to develop human hepatocyte-like cells from stem cells that are derived from embryonic, bone marrow, mesenchymal and adipose tissues. The human hepatocyte-like cells can be used for in vitro assays for screening and testing potential drugs for the pharmaceutical and nutraceutical industries. According to Ahmad Zaharudin, the company is projecting a revenue of RM15 million to be generated from the product, knowledge transfer and licensing of technology as outcome of the partnership.

Genzyme Corporation announced that the U.S. Food and Drug Administration has granted marketing approval for Mozobil(TM) (plerixafor injection), a drug intended to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). The product has also been granted orphan drug designation. Genzyme has submitted an application in Europe for approval of Mozobil and expects approval of the product in the second half of 2009. Genzyme recently filed applications in Australia and Brazil, and additional global applications in up to 60 countries are planned. Mozobil has received orphan drug designation in Mexico which allows the product to be commercialized in the country upon U.S. approval. Genzyme believes that Mozobil may have broad application outside the current indication. Early preclinical and clinical investigations are already underway to explore additional therapeutic indications for Mozobil, including mobilization of hematopoietic stem cells in allogeneic stem cell transplants and tumor sensitization in oncology/hematology treatments such as adult myeloid leukemia.

And finally... it looks like there's a showdown shaping up in Colorado. As disucssed previously on this blog, in July FDA CBER's Mary Malarkey sent a warning letter to Dr. Christopher J. Centeno, Medical Director of Regenerative Sciences, Inc (RSI), doing business as Regenexx. On a recent visit to the Regenexx website, we see that they state the following:

"The Food & Drug Administration's (FDA) role is to regulate the sale and distribution of drugs, devices, biologics and combination products, but not how these products are used by physicians. The FDA does not approve surgical procedures. RSI conducts all surgical procedures within the State of Colorado. There are no interstate aspects to the procedures conducted by RSI that invoke FDA jurisdiction under the Public Health Service Act (PHSA), which requires an interstate nexus. Our surgical procedure involve the use of autologous stem cell therapies (ACTs) consisting of products or treatments incorporating the in vivo use of a patient's own stem cells, following, in certain circumstances, ex vivo manipulation or processing, for the prevention, or treatment of disease. The surgical procedures conducted by RSI including surgery and bone marrow transplants are not performed as part of any research intended for FDA approval of a product that is under the jurisdiction of the FDA. Therefore, the stem cell procedures conducted by RSI are not under the jurisdiction of the FDA. Rather, the procedures conducted by RSI are considered the "practice of medicine," and is left up to individual surgeons' judgment and experience and oversight by the Colorado Board of Medicine." [emphasis added]


And that ends the way I saw the cell therapy industry this week.... More HiLites to come in 2009! Happy holidays to one and all.

--Lee

Cell Therapy HiLites 2008-11-28

For what is typically a slow business week in the US, the cell therapy sector had some big news. More money, more deals, and some interesting developments to watch.

Argos Therapeutics completed a second and final tranche of a $35.2 million Series C financing from new and existing investors (the first tranche was completed in April 2008) to support ongoing phase II trials of its RNA-loaded dendritic cell product in renal cell carcinoma and HIV as well as support the further pre-clinical development of its CD83 soluble protein for transplant rejection/autoimmune disorders

In a move I'd say has some elements of "perfect timing", Novocell CEO, Alan Lewis, announced he plans to leave the company after 3 years at the helm to head up the well-funded and well-connected JDRF. Alan positioned the company well and leaves it with a healthier cash balance than many in its position. Due to the nature of ESC work and the financial markets Novocell has an arduous road ahead of it but they are at the forefront and have the backing from some heavy hitter investors.

Sigma-Aldrich entered into a research collaboration with South Carolina's D-Finitive Cell Technologies, Inc. The collaboration is expected to support the development and commercial offering of 14 products over a two-year span with a planned launch of many of these products in 2009 expected to consist of serum-free media for bone marrow and umbilical cord stem cells, mesenchymal stem cells and neural stem cells; cytokine cocktails for stem cell expansion and differentiation; novel formulations for cyropreservation of stem cells; and specialized products to conduct clonogenic assays of the various stem cells. Paul Price, the man behind the science at D-Finitive, is a key component to the deal.

James Thomson's Cellular Dynamics International- focused initially on creating cells for pharma toxicity testing - merged with its two sister companies, Stem Cell Products Inc. and iPS Cells Inc. and raised $18 million (link).

t2cure acquired a patent family in in vitro potency testing patents for testing of stem cells for cardiovascular applications which it intends to use in its phase III trial starting next year.

Cytori announced it is strengthens it European Union sales, training and service operations with key hirings and expansions. The company is introducing its Celution^® 800 System in Europe into the reconstructive surgery market. The Celution® Technology has been developed as a bedside device to enable real-time, adult stem and regenerative cell processing. The technology automates and standardizes the separation and concentration of a patient’s own (autologous) adult stem and regenerative cells from body fat (adipose) for real-time redelivery to the same patient - at the moment primarily patients recovering from the effects of breast cancer treatment.

Something's up at Stem Cell Sciences. Last week they announced they had signed a Master Service Agreement of up to five years with Pfizer Limited, the UK operating unit of the global research-based pharmaceutical company Pfizer, Inc. (NYSE: PFE - News). Under the terms of the agreement, SCS will provide research services, cell lines, media and reagents to support Pfizer's R&D efforts in the field. It is no secret the company has been busily reinventing itself and signing of a major deal with a pharmaceutical has been one of their stated goals since they did a major re-org of the company. Nevertheless, on the heals of the deal the company announced that they requested a temporary suspension in the trading of its shares ahead of what it described as a review of its financial position and strategic options. It will be curious to see what transpires.

As Jon Rowley pointed out, last week I missed Aastrom's announced treatment of the first patient in its U.S. Phase II trial of their Cardiac Repair Cells (CRCs) in the treatment of dilated cardiomyopathy (DCM).

That's just the way I saw cell therapy this week...

The Perfect M&A Storm is Brewing.

I'm not going to write only about the financial side of cell therapy sector but I'm on a roll here so I'll continue on the theme for at least on more post.

I've been privy to a lot of conversations recently in which M&A is on the tip of everyone's tongue. I'm likely not going out on too much of a limb - and certainly won't be the only one on it - when I make the prediction that the next 12-24 months is going to see a spike in M&A activity at all levels in the cell therapy industry.

I don't think I need a hard data set to convince you that we've seen an increase in M&A activity over the past 6 months.

This I know:

• There is a fair amount of M&A activity right now in the sector.
• The M&A pendulum has now swung back to the "sexy" side after falling out of favor for some time.
  
• A high percentage of companies in the sector are expressing interest in some level of merger or acquisition.
  
• There are a lot of M&A discussions currently being explored.

Certainly we're seeing this in the larger biotech sector with Roche's offer for Genentech, MacroGenics' acquisition of Raven Biotechnologies, Lonza's purchase of Amaxa Biosystems, and Invitrogen's merger with Applied Biosystems as prime examples just in the past few weeks alone.

There is a perfect storm of factors brewing up the ideal climate for a spike in M&A. VCs are increasingly tightfisted and conservative about life sciences for now, capital markets are tough with predictions it won't get better for some time (see today's IN VIVO blog), and - to round out the trifecta - the sector's maturation translates into increasingly larger burn rates for a higher number of cell therapy companies in later stage trials.

I'm not in the business of spilling confidential information or spreading rumor so any companies mentioned below are used simply by way of example. Don't assume I know something you don't know about any of the companies referenced below.

So what might this potential M&A dustup look like?

It will certainly involve many smaller companies - think Onyvax, KeraCure, Aastrom, Memgen, ReNeuron, HemoGenix, Novocell, Opexa, IRX, BioLife Solutions, BioSafe, Cellerant, Eufets, Progenitor Cell Therapy, Angel Biotech, Epiontis, ISCO, Lifeblood Biological Services, Stem Cell Sciences, Thermogenesis, TiGenix - some of which will look to M&A to solve their fundraising needs and others will be M&A targets because of their revenue stream.

Larger companies are not likely to be immune from this swing of the M&A pendulum - say (for example!) Dendreon, Neurotech or even - might it be possible - Osiris? The newly improved, profitable, and growing Organogenesis might be a target for its revenue and Stem Cells Inc has been none-too-shy about its M&A intentions for some time. It may involve some bigger companies in the sector - say like Genzyme or Caridian BCT (formerly GambroBCT) which we know is almost certainly being positioned for a resale by the private group that bought it to maximize its value for resale.

What is not clear is who might be the buyers. Potential companies that pop to mind include BD , Celgene, and J&J. Might Amgen make a play? What about Shire, Schering, or any of a number of other pharma looking to diversify their sagging pipelines and bolster their lackluster innovation initiatives. There will likely be other players external to the field who use M&A as an entree into the sector - think Reliance Life Sciences

We know Hospira is making a play in the cell therapy space with several investments they won't yet disclose. They hiring key and experienced executives (e.g., K. Gunter from ViaCell some time ago and recent D. Perritt from J&J). It would appear they are positioning to make a significant play in the market and it would not be surprising to see it in the services side of the sector.

It is likely to be an interesting year or two for cell therapy. On the other side of it, the industry will likely look much different, be more robust, held by a much wider diversity of parent companies, investors, and shareholders, and likely somewhat more integrated with other biotech/pharma.

So...make sure your boat is tied up, get a good window seat (if you're a watcher) or a kite sail (if you're want to participate), and let's have fun. Let's make sure smart deals get done that get good technologies in the hands of companies that will make them work - as therapies, as the base of sold companies, and rewarding to investors with the cojones & foresight to put cell therapies in their portfolio.