Cell Therapy Industry HiLites 2009-06-26

Let's get the public services announcement out of the way right up front.

• CellTherapy 2010. Save the date. Submit your session ideas. www.celltherapy2010.com

• While you're planning your calendar, plan on the 2009 World Stem Cell Summit September 21-23, 2009. Baltimore Convention Center Baltiomore, Maryland. (the 2008 World Stem Cell Summit webcast and downloadable World Stem Cell Report are at www.worldstemcellsummit.com).

• Curiously, the Regenerative Medicine Foundation (I know. I hadn't heard of it either until now.) has announced that its "Translational Issues in Regenerative Medicine" conference is the "premiere event for leaders in regenerative medicine translation, representing academic research, clinical, healthcare policy, regulatory, reimbursement, investment and biotechnology industry interests." Curious because it has yet to ever occur. That being said, if they do what they promise, it may just well be. I'm trying to learn more and when I do I'll let you know. Meantime, this is about all I know:
  

Spring 2010
Twin City Quarter
Winston-Salem, NC

"...to facilitate business development opportunities, the conference will feature a venture forum including 15 regenerative medicine companies, as well as partnering sessions."

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Do yourself a favor. Stop monkeying around with home-made cryopreservation brew or, for than matter, any media not built to minimize cellular damage from freezing and thawing.

Do your cells a favor. Try CryoStore and HypoThermosol.

www.biolifesolutions.com

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I'm dedicating this issue of Cell Therapy Industry HiLites to TiGenix NV (NYSE EURONEXT: TIG). TiGenix wins the Cell Therapy Group "kick-ass cell therapy company of the week" award which is, of course, something I just made up but they had have a great week raising several million dollars, announcing plans for a new European facility, and receiving a positive opinion from the EMEA CHMP which all but assures them of an MAA within 90 days applicable in 30 European countries. See details below.

FINANCE

TiGenix (NYSE EURONEXT: TIG) has secured the necessary financing to fund the set-up of a GMP manufacturing facility in Europe through a private placement for a total amount of EUR 5,4 million. The investment agreement was subscribed by NV Industriebank LIOF, Particon BV, Limburg Ventures BV and LRM NV. The funds will be used to set up a new cell expansion facility in Europe for the commercial production of its cell based products in the Netherlands. The financing for the facility has been secured through a private placement. After carefully evaluating a number of options throughout Europe, taking into consideration technical, logistical, regulatory and financial criteria, TiGenix has selected a building on the Chemelot Campus, near to Maastricht, the Netherlands, to locate its new cell expansion facility. The site is centrally located in TiGenix’ key European markets, in a region that is strong in distribution and (bio)logistics and that is highly committed to develop as a transnational knowledge centre in life sciences and regenerative medicine.

This financing has now been completed following the execution of a long term lease agreement for the facility in question.

**

After raising $40+ million last year and over $14 million so far this year, Cytori Therapeutics Inc (NASDAQ: CYTX) has announced it has entered into an agreement to raise up to another $20 million over the next year. The company announced recently that it had raised $850,000 in what is described as an agreement by Orlando, FL-based fund, Seaside 88, to buy 7.15 million shares over the next year by buying a specified allotment every two weeks at an agreed discount of the then current stock price. The agreement could being in roughly $20 million for the company depending on share price. Cytori intends to use the proceeds to "accelerate marketing efforts and continue our investment in clinical trials to broaden the number of potential applications for which the Celution® System may be applied".

**

A bankruptcy court hearing is scheduled for July 6 in which Isolagen Inc. (AMEX:ILE) will request final approval of its debtor-in-possession financing plan under Chapter 11 bankruptcy reorganization protection.

**

Always a master at the art of spinning good profile, NeoStem, Inc. (NYSE: NBS) (AMEX: NBS), in the business of collection, processing and long-term storage of adult stem cells for future medical need, garnered a feature in Gene Marcial's prominent Business Week column, "Inside Wall Street," on June 18, 2009. The same week saw the company profiled in a piece on the investment potential for adult stem cell businesses in a Fortune Magazine article distributed by CNNMoney.com. The company has been on a deal-making, press release and publications tear the past few months. "Big plans by tiny NeoStem (NBS)," Mr. Marcial observed, "have helped catapult its stock to $2.27 a share from 50 cents on March 9." It must be the plans because the company which has been doing what it does since 2006, generated a mere $45,100 in total revenuefor the three months ended March 31, 2009. The good news is that is up from the $700 generated in the three months ended March 31, 2008.

The company also announced another deal saying it has signed an exclusive 10-year agreement with Enhance BioMedical Holdings Limited, a Shanghai corporation, to develop a Stem Cell Collection and Treatment Network using NeoStem's "technologies" Taiwan, Shanghai and the Chinese provinces of Jiangsu, Zhejiang, Fujian, Anhui and Jiangxi. Enhance BioMedical Holdings is a subsidiary of Enhance Holding Corporation, a multinational conglomerate whose CEO, Jackson Ling, recently invested $5 million in an $11-million private placement financing for NeoStem.

CLINICAL

Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced six-month interim data from a Phase II clinical trial evaluating Prochymal, the Company's formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). The trial failed to demonstrate an improvement in pulmonary function in COPD patients. The company, quickly becoming practised at spinning what might be considered bad news, said they were pleased the data did provide additional evidence of safety for the product in addition to demonstrating significantly decreased inflammation in the COPD patients. Sixty-two patients were enrolled and are being followed for two years in the placebo-controlled study.

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Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT) received approval from the Paul Ehrlich Institute to begin clinical trials evaluating the company’s placental-derived adherent stromal cell product, PLX-PAD, for the treatment of critical limb ischemia.

**

Aastrom Biosciences’ (NASDAQ:ASTM) trial of its cell therapy for severe chronic heart failure was released from a clinical hold by the FDA. The the agency determined the therapy did not cause the death of a participant which resulted in the hold in May.

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The University of Pittsburgh Cancer Institute began enrolling patients in a Phase III study evaluating the safety and efficacy of Gamida Cell Ltd's StemEx cord blood stem cell therapy for the treatment of blood cancers.

**

Having received regulatory approval late last year to proceed with its clinical trial in New Zealand, Living Cell Technologies Limited (ASX:LCT; OTCQX:LVCLY) CEO Paul Tan said enrolment of patients should be complete in about two months to begin testing their pig islet cells implanted in humans to treat diabetes.

**

Neuralstem, Inc. (NYSE Amex: CUR) has entered into a sponsored research agreement with the China Medical University & Hospital of Taiwan, in Taichung, Taiwan, to prepare for a human clinical trial using Neuralstem’s human spinal cord neural stem cells to treat stroke patients. The therapy will focus on patients whose post-stroke symptoms, including complete or partial paralysis, have stopped improving more than six months after an ischemic stroke.

COMMERCIAL

Not to be outdone by finance and operational teams, the regulatory team at TiGenix also announced reason to celebrate this week. TiGenix (NYSE EURONEXT: TIG) announced that the company received a positive opinion from the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for
its lead product ChondroCelect.

CHMP opinions are forwarded to the European Commission for adoption of the final community Marketing Authorisation, which is typically issued between 60 and 90 days from adoption of the CHMP opinion. I'm told that European Commission generally follows the advice of the CHMP but, as Dendreon, there's little reason to celebrate until the formal approval is formalized. For the EMEA take and related info on the decision, click here.

Upon approval, ChondroCelect will be, I believe, the first product approved under the new ATMP regulatory framework. It will certainly be the first cell based product to be centrally approved in the 27 member states of the European Union as well as in Iceland, Lichtenstein and Norway under the new Advanced-Therapy Medicinal Products (ATMP) legislation.

**

Further to my March 31 speculation about who might be the buyer of York Pharma plc (and its two cell therapy products on the market) and my April 13 post that ULURU Inc. (NYSE Amex: ULU) had signed a non-binding offer letter to acquire the company, ULURU Inc. (NYSE Amex: ULU) has announced that at this time discussions to acquire York Pharma, plc have been terminated. ULURU has notified York that the $1 million USD line of credit it had extended York are due plus accrud interest. The revolving credit facility is secured by substantially all of the assets of York and its subsidiaries. York is now actively pursuing alternative funding facilities in order to repay the line of credit within 30 days and to meet its ongoing working capital requirements.

Meanwhile, rumor has it the company is already in talks with another potential suitor.

**

Here are a couple hints for your next press release. It's rarely newsworthy to have as the primary point of your release an announcement about what you are going to do, rather than what you've done; secondly, don't announce seemingly contradictory information. I'm just saying....

Stem Cell Therapy International, Inc. (OTCBB: SCII), through its wholly owned subsidiary AmStem International, Inc., announced that it has "started the process" to enable it distribute Histostem's products in anticipation of the finalization of the merger between Stem Cell Therapy International, Inc. and Histostem. This is intented, according to the SCTI President and CEO, to "enable AmStem International, Inc. to begin US distribution and immediately bolster the company's cash flow". However, the product has yet to be the subject of a clinical study in the U.S. for which they are seeking "investigators...of the highest caliber, to compare its Stem Cell Facial Cream with others on the market."

The companies reportedly continue "to work on the necessary steps to finalize the merger, and both sides are working diligently to manage its many details."

**

Community Blood Services has entered into a licensing agreement with AuxoCell Laboratories, Inc. to use AuxoCell’s exclusive patent rights and propriety process to extract fetal mesenchymal stem cells from the Wharton’s Jelly of donated umbilical cords, allowing Community Blood Services to operate the first Wharton’s Jelly derived stem cell bank in the United States.

**

After netting $221 million last month by nearly 12 million shares at $19.20 apiece, Dendreon Therapeutics Inc (NASDAQ:DNDN) expects to spend up to $50 million in a two-phase expansion of its manufacturing facility in Morris Plains, New Jersey. Monday in a regulatory filing. Additional quality control laboratories, data center, training areas, infrastructure and offices are scheduled to by done by mid-December. The final phase, with additional manufacturing clean-room work stations, production support areas, warehouse, infrastructure and offices, is to be substantially complete by April 23 of next year. Dendreon finished the initial build-out of its 158,000-square-foot facility in July 2006, before its FDA application was tabled to await additional clinical results.

**

Apparently yet another way has been invented to derive stem cells from placenta - reportedly a source much richer in stem cells than umbilical cord blood. The inventors are looking for commercial partners.

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Cell Genesys, Inc. (NASDAQ:CEGE) - the company that just won't go away - is still pursuing "strategic alternatives". Meanwhile, it expects its cash balance will be approximately $36 million upon imminent completetion of its stock exchange offer.

MISCELLANIA

This week's issue of Science has a special focus on stem cells including a piece on "FDA Regulation of Stem Cell–Based Products" by Donald W. Fink, Jr. of FDA, CBER, an article on stem cell tourism and 3 reviews. 26 June 2009. Vol 324, Issue 5935, Pages 1603-1754

**

The Production Assistance for Cellular Therapies Group (PACT) Educational Web Seminar: Topic: "Deviation Management of Type 351 & 361 Cell Products" Date: Thursday, July 16, 2009 Time: 12:00pm-1:00pm (Eastern US Time) Register is now open for this Web Seminar at www.pactgroup.net.

Sign-off

Thanks again to BioLife Solutons. Congratulations to Tigenix. May the force be with all of you and for those going to ISSCR later this week....safe travels and please try not to enjoy Barcelona too much without me!

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.

*

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."

*

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."

*

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.

*

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.

*

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.

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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.

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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.

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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".

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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.

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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.

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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.

Another imminent M&A in cell therapy?

Is another company with commercial cell therapy products about to be bought for a song?

York Pharma PLC (AIM:YRK) is a pharmaceutical Group established in 2003 specializing in the acquisition, development and commercialization of novel prescription dermatological products to market and supply branded prescription products to pharmaceutical wholesalers, hospitals and general practitioners within the field of dermatology.

University of Sheffield spin-out CellTran Ltd was incorporated in 2000 specializing in developing cell therapies to heal wounds. During its existence the company succeeded in bringing two cell therapy products into the UK market for the treatment of chronic wounds and burns: Myskin™ and Cryoskin™. CellTran majority shareholders were Biofusion plc, White Rose Technology Limited, The YFM Group, South Yorkshire Investment Fund, Partnerships UK and the Wellcome Trust.

In my December 12 post here on this blog, I reported the following:

One of the more important bits of news I'm late to the table for (announced at the end of October) is the acquisition of "certain of the assets and the continuing business of Celltran Limited (“Celltran”) from its administrators" by York Pharma plc (AIM: YRK) for what it describes - in the very undestated British way - a "compelling valuation".

This seems an apt description when one learns that despite the fact that "approximately £15 million has been invested in the Celltran portfolio of products" to-date, York bought the company's two commercial product plus "a rich pipeline of associated products and technologies" and the ongling business for - make sure you're sitting down - "£70,000 plus the payment of royalties on future sales for a period of five years (at the greater of £100,000 (£20,000 per year) or 10% of future revenues generated by the products over such period)".

The real reason this is such a compelling valuation is that Celltran had - and now York Pharma has - two cell therapies on the market (albeit only in the UK) in Myskin™ and Cryoskin™.

But the news does not end there. York also announced simultaneous to the acquisition that they had completed an institutional placing raising £510,000 (before expenses) to provide "additional working capital for the integration, operation and further development of the assets within York Pharma’s business." York, established in 2003, describes itself as a pharmaceutical group with particular focus on dermatological products which makes the two cell therapy products fit well in their existing portfolio.

Now York Pharma is on the ropes.

It was reported today that "shares in the AIM-listed York Pharma were suspended from trading after the company said that it still hadn’t managed to secure any short term funding and as a result would miss the March 31 deadline to publish its annual results. Earlier this month York said it was in talks with two potential offerors and that those discussions included the provision of short term funding facilities. The company said it needed the cash to allow it to continue trading through the period needed to complete any formal offer."

It was then reported later today that "one of the potential offerors has today entered into an agreement with the Company to provide the Company with a secured revolving Credit facility of up to US$1,000,000" and that "drawdown of the full facility should allow the company to continue trading through the period needed to complete any formal offer".

Now this begs the question: who is the suitor? One one hand this smacks of exactly the kind of move StemCells Inc has made more than once in the past. Would this fit with their other recent UK acquisition? With two products already on the market would this address STEM's need for immediate revenue to fund its ongoing therapeutic development programs? While the answers might be "yes", I doubt this kind of move is within STEM's bandwidth given the ink is not yet even dry on the SCS deal (not sure it is even closed). If not STEM, then who?

Certainly this would be a fit with Advanced BioHealing's portfolio or that of Karocell Tissue Engineering AB, FIDIA Advanced Biopolymers, or Forticell Bioscience (formerly Ortec International, Inc.). Would Genzyme or a pharma company pick this up? I have my doubts. Perhaps an Asian company like Japan Tissue Engineering Co., Ltd. (J-TEC)? It might also be quite compelling to merge this with Intercytex and create a company with several commercial cell therapy products and a rich pipeline of products.

It's likely none of the above but it is fun to speculate. I'm sure we'll find out in the next few days...

Cell Therapy Industry HiLites 2008-12-12

Rumor is there was little in the way of cell therapy at the ASH meeting this year and the TERMIS meeting was mostly "basic research". I'd love to hear other reports. Maybe because of that, it seemed oddly slow on the cell therapy front this week. Despite that, we've got some interesting news to review.


This issue of Newseek had an article by David T. Scadden, M.D. and Anthony L. Komaroff, M.D. "Will Stem Cells Finally Deliver? Major breakthroughs are propelling the field. Science becomes medicine."

TiGenix secured grant support to deepen its pipeline. The company has been awarded a €1.81 million, or $2.41 million, grant to support its R&D efforts a meniscus repair program. The two-year program will focus on the further development and application of allogenic stem cells in combination with a biocompatible scaffold, the identification of biomarkers predictive for the quality of meniscus-like tissue, and establishing preclinical proof-of-principle for cellular repair of meniscus lesions.

The European registration procedure for its lead product, ChondroCelect®, is reportedly progressing. As this is the first cell based product submitted to the EMEA under the central registration procedure, some further documentation on the product and process validation processes was recently requested by the regulatory authorities. The company is apparently now compiling further information for submission, and expects the CHMP to issue an opinion on the marketing authorization for ChondroCelect in the first half of 2009. If approved, ChondroCelect will be the first cell-based product to receive a central marketing authorization for an advanced therapy medicinal product in Europe. The preparation of the Biologics License Application (BLA) to obtain product registration in the US is also reportedly progressing according to plan. The company intends to start the registration process with the US Food and Drug Administration (FDA) in the first half of 2009. (for a recent TiGenix update, click here).

Athersys received its third IND for MultiStem in less than a year with authorization to proceed on a phase I trial in the treatment of ischemic stroke.

CIRM grants were approved to 4 San Diego biotechs:

• $827,072 for Novocell to advance development of “an implantable device” to capture and retain pancreatic stem cells.
• $749,520 for a joint effort by Fluidigm of South San Francisco and StemGent, a Cambridge, MA, biotech with operations in San Diego, to develop a screening technology to help stem cell researchers “reverse engineer” skin cells into stem cells.
  
• $869,262 for an application by Invitrogen, now known as Life Technologies, for developing methods of modelling human neurodegenerative diseases in human embryonic stem cells.
• $906,629 for Vala Sciences to develop new and improved techniques for developing mature heart cells called cardiomyocyte cells from human embryonic stem cells.
  

Immunotherapy has certainly seen its share of failures but T-cell oriented therapies are not going away as they continue to attract funding by companies looking to avoid the difficulties that have sunk other efforts to commercialize immunotherapies. One such new company is Adaptimmune Ltd which recently spun out of MediGene AG to carry forward T cell receptor engineering with HIV as its initial target. The company's ex vivo approach sees a patients' own T cells harvested, those cells' receptors genetically enhanced for increased potency against certain infections or tumors in the manner of monoclonal antibody selection, and re-infused into the patient.

Osteotech authorized a stock buyback of up to $5 million.

Novocell announced it will collaborate with renowned stem cell researcher Shinya Yamanaka of Kyoto University to explore the creation of human islet cells from iPS cells. Common wisdom says Novocell has been in the lead in the race to a cell-based approach to diabetes therapy but they are not without competition. Earlier in the year giant Novo Nordisk did a deal with Cellartis and Lund University to create insulin-producing cells for diabetes. Novo Nordisk has been selling insulin since 1923 and knows the diabetes market well. Additionally, Geron announced a publication on its progress coaxing embryonic stem cells into what it calls islet-like clusters.

ERYtech Pharma announced the results of its phase II clinical trial. ERYtech Pharma, the specialty pharmaceuticals company developing red cell-based medicinal products, announces the results of its phase II clinical trial. GRASPALL 2005-1 was presented orally on the 8th December 2008 at the 50th Annual Meeting of the American Society of Hematology in San Francisco (USA). This study aimed to assess the efficacy and the safety of 3 doses of GRASPA®, a new formulation of L-asparaginase, given in frontline treatment for children and adults with
relapsed acute lymphoblastic leukemia (ALL).

In a December 3 press release and conference call ThermoGenesis announced it has reached an agreement with CEO William Osgood for his immediate resignation. This comes as a result of a clear disagreement between Osgood and Board regarding future directions of the company. A search for a new CEO will be launched. In the interim, the board has named Matthew T. Plavan, the Company’s Executive Vice President and Chief Financial Officer, as ThermoGenesis’ interim Chief Executive Officer. The company has announced its intention to reorganize, downsize, maximize, sideline its Vantus business, and dispose of the ThermoLine™ business yet this quarter.

BioLife Solutions was granted a European biopreservation patent expanding its IP related to technologies which minimize cell death during or resulting from cell preservation.

Chemokine Therapeutics Corp. (CTI.TO) filed Chapter 11 equivelant in Canada - a Proposal to Creditors under the federal Bankruptcy and Insolvency Act.

Stem Cell Therapy International Inc. announced the elimination of what it described as "major obstacles" previously blocking its merger with Histostem including the establishing of a relationship with a clinic in Mexico. The companies are apparently in the final stages of completing the merger to create AmStem International and begin creating revenue almost immediately presumably involving a new relationship with U.S. company, Cancun Stem Cell Clinic, Inc. (with its stem cell clinic in Cancun, Mexico) and Histostems cord blood banking operations.

MicroIslet Inc. is reorganizing its way through Chapter 11 with the help of new financing.

Pluristem received a $1.6M grant from the Office of Israel’s Chief Scientist. The non-dilutive funds will be designated to support the clinical trials of the Company as well as research and development activities.The grant covers the development costs of their PLX cells from March 2008 to February 2009. Furthermore, Pluristem plans to submit an application for a new grant to the OCS in March 2009 to cover the Phase I trial of PLX-PAD and pre-clinical studies of PLX-IBD, targeting Inflammatory Bowel Disease (IBD).

HCT/P establishments must complete annual registration by end of this month. Establishments that manufacture human cells, tissues, and cellular- and tissue-based products have until Dec. 31 to complete their annual registration with the Food and Drug Administration. Instructions for listing HCT/Ps have been revised this year, as have policies and procedures for submitting the form. FDA is encouraging facilities to submit the form thr obtained subject to court approval.ough electronic registration. Review the revised instructions or submit form electronically.

Interesting perspective on stem cells in biotech in BIO's year-end summary of the most important trends and stories of 2008 and looking forward to 2009.

In the spirit of passing along interesting resources, here are a couple I came across this week:

• How Stem Cell Research is Transforming Health Care. A panel discussion from the 2008 World Stem Cell Summit with panelists: Alan Trounson (California Institute for Regenerative Medicine), Lawrence S.B. Goldstein (University of California-San Diego), and John Wagner (University of Minnesota). Moderator: Timothy Kamp
• Steven Badylak @ Pop!Tech 2008. Last year regenerative medicine expert Dr. Badylak made news in the medical world when two of his patients re-grew severed fingertips in just six weeks. He spoke at this year's Pop!tech on how he and his colleagues are applying this breakthrough solution to help Iraqi war veterans re-grow tissue and body parts lost in battle.

Finally, it always disturbs me when I miss important news in the industry because it tells me there are holes in my systems. It also troubles me when I discover cell therapy companies that I here-to-fore did not know existed. Both happened to me this week. Nevertheless, better late to discovery than not at all.

One of the more important bits of news I'm late to the table for (announced at the end of October) is the acquisition of "certain of the assets and the continuing business of Celltran Limited (“Celltran”) from its administrators" by York Pharma plc (AIM: YRK) for what it describes - in the very undestated British way - a "compelling valuation".

This seems an apt description when one learns that despite the fact that "approximately £15 million has been invested in the Celltran portfolio of products" to-date, York bought the company's two commercial product plus "a rich pipeline of associated products and technologies" and the ongling business for - make sure you're sitting down - "£70,000 plus the payment of royalties on future sales for a period of five years (at the greater of £100,000 (£20,000 per year) or 10% of future revenues generated by the products over such period)".

The real reason this is such a compelling valuation is that Celltran had - and now York Pharma has - two cell therapies on the market (albeit only in the UK) in Myskin™ and Cryoskin™.

But the news does not end there. York also announced simultaneous to the acquisition that they had completed an institutional placing raising £510,000 (before expenses) to provide "additional working capital for the integration, operation and further development of the assets within York Pharma’s business." York, established in 2003, describes itself as a pharmaceutical group with particular focus on dermatological products which makes the two cell therapy products fit well in their existing portfolio.

So for what its worth...that's the cell therapy industry I saw this week.