Cell Therapy Industry HiLites 2009-03-13

I know, I know. I'm way off schedule. I'll try to post some shorter, snappier editions of the Cell Therapy Industry HiLites over the next few days in order to catch up but you know what they say about good intentions...

CIRM is repositioning itself more firmly as a translational agency, preparing for NIH to take on some of the burden of funding basic research.

One cell therapy and one cell-based gene therapy made R&D Direction list of 100 great investigational drugs for 2009 as selected by the editors: Prochymal (allogeneic mesenchymal stromal cells) by Osiris/Genzyme for acute mycardial infarction and VRX496 (lentiviral vector transduced autologous CD4 T cells) for HIV/AIDS.

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FINANCIAL

Perhaps a sign of the times, I discovered this posted on LinkedIn recently:

Opportunity to acquire assets of a preclinical diabetes therapy company in Chapter 7
MicroIslet, Inc. has developed a treatment for Type 1 Diabetes involving the transplantation of non-human islet cells. Due to the company's previous capital structure and the collapse of the capital markets in late 2008, MicroIslet filed for Chapter 11 reorganization. The bankruptcy case was converted to Chapter 7 liquidation last month.

The estate owns significant intellectual property and is party to an exclusive contract to source islet cells from a unique supplier. Management estimates a six month time frame to file the IND. Animal and toxicity studies are complete with favorable results.

For more information about the company and its assets visit www.microislet.com or reply to me.

Thank you
Brian Conn
Chief Financial Officer at MicroIslet, Inc.

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Last year, Cytori Therapeutics, Inc. (NASDAQ:CYTX) raised $12 Million in February in an equity purchase and strategic collaboration agreement with Green Hospital Supply, then in August they announced raising $17 million from a private placement financing led by Olympus Corporation (TSE: 7733) with participation from select institutional investors, and finally in October they entered into a $15 million loan facility with GE Healthcare Financial Services and Silicon Valley Bank.

Despite all this, in the company's Form-10K filed with the SEC on March 6, 2009, the Company's auditors issued an audit opinion that includes a matter of emphasis paragraph relating to the Company's ability to continue as a going concern.

Consquently, this week the company announced it had closed and received net proceeds to raise $10 million, before placement agent fees and offering expenses. The funds will be used for sales and marketing activities related to the commercialization of the Celution(R) System and consumables as well as other related and complementary products, for ongoing clinical studies of the Celution(R) System for breast reconstruction and cardiovascular disease, for ongoing research and development to support the Company's products and its pipeline development, and for general working capital.

Due to the closing of the financing subsequent to the issuance of the auditor’s opinion, Cytori has substantially improved its cash position, which the Company believes may fund its operations through at least 2009 as described in the liquidity and capital resources discussion of its Form-10K.

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MolMed S.p.A. (Milan:MLM) Board of Directors reviewed and approved the draft year-end financial statements as at 31 December 2008. The company reported a Positive net financial position of €35.3 million, consisting of cash, cash equivalents and current financial assets, operating costs totalling € 23.1 million, and a loss of € 17.4 million (an average of over €1.4 million/month on average), as compared to a loss of € 12.7 million in 2007. The notable improvement of MolMed’s net financial position, from € 5.7 million as at 31 December 2007 to € 35.3 million as at 31 December 2008, is due to the IPO proceeds of €56.2 million derived from MolMed’s listing at the Milan Stock Exchange.

Almost in passing the year-end review stated that MolMed and Takara Bio Inc. have agreed to terminate their research collaboration in AIDS gene therapy to give full focus to their respective, more advanced programs .

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Stem Cell Therapy International Inc. (OTC BB:SCII.OB) announced that they have obtained short term financing, enabling the Company to "update" and finalize the merger between Stem Cell Therapy International, Inc. and the Histostem Corporation, Ltd. (Korea) which has been filed previously with the SEC. I don't know what it means to 'update' a merger but it would appear this loan will get it finalized.

The Company got a whopping $150,000 and 6 months or less to repay to the lenders $187,500.
This short term financing will allow the Company to continue to "pay necessary vendors to maintain the Company's public filing requirements, begin collaborations of operations between Histostem and AmStem International, finish the documents necessary to continue with the private placement and proceed with the execution of the Company's strategic plan."

AmStem International is the name of the new company intended to result from the merger of Stem Cell Therapy International, Inc. and HistoStem, Ltd. of Korea. Histostem reportedly operates the largest accredited Cord Blood & Stem Cell bank in the world (more than twice as large as its nearest competitor) and is said to be already successfully treating patients with its patented, Korean FDA-approved stem cell therapies. Histostem is one of only a few stem cell companies in the world currently earning several million dollars in income from its cellular products and technology.

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CLINICAL

While desperately looking for enough cash to last beyond month's end, Isolagen, Inc. (Amex: ILE) has managed to submit its Biologics License Application (BLA) for Isolagen Therapy, a cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. Food and Drug Administration (FDA). The Company's wrinkles/nasolabial folds Phase III trials were conducted under an FDA Special Protocol Assessment. The company also recently completed its Phase II/III trial for the treatment of acne scars with statistically significant efficacy results. Meanwhile the company is actively pursuing financing and/or strategic partnerships including the potential sale of its 57% ownership interest in Agera Laboratories, Inc.

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TissueGene, Inc. announced that its South Korean licensing partner Kolon Life Science, Inc. (KLS) has received regulatory allowance from the Korea Food and Drug Administration (KFDA) to initiate a Phase IIa clinical trial of TissueGene-C (TG-C) in patients with severe osteoarthritis of the knee. TG-C has been developed for the localized delivery of allogeneic human cells expressing TGF-beta1 in order to induce the regeneration of cartilage. TissueGene is currently completing Phase I clinical trials in the U.S. and continues to work closely with KLS in order to coordinate their regulatory efforts and efficiently conduct parallel clinical trials for TG-C in both the U.S. and Korea. In Asia, TissueGene has licensed intellectual property rights to KLS, a subsidiary of Kolon, for the clinical development and commercialization of TissueGene's lead product candidates TG-C and TG-B, developed for the regeneration of cartilage and bone, respectively.

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The Gamida Cell-Teva joint venture announced that orphan designation was granted by the European Commission for the investigational medicinal product StemEx® for the treatment of acute lymphoblastic leukemia and acute myeloid leukemia. The European Commission consequently follows the positive opinion of the European Medicine Agency's Orphan Medicinal Products Committee. The FDA granted StemEx orphan drug designation in March 2005 for use as hematopoietic support in patients with relapsed or refractory hematologic malignancies (cancer of the blood system) who are receiving high dose therapy.

StemEx is a graft of expanded stem/progenitor cells, derived from a single unit of umbilical cord blood and transplanted in combination with non expanded cells from the same unit. It is currently being researched as an alternative to a bone marrow transplant, for patients with certain blood cancers, in an advanced Phase III, pivotal study called ExCell

By EU regulation, orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives. Benefits include, among others, market exclusivity in the European Union for 10 years from the date of the orphan medicinal product designation and an EMEA fee-reduction for the drug.

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Stemedica Cell Technologies, Inc., ("Stemedica") announced that they had received the results from a Stemedica-sponsored clinical study conducted by "renowned stem cell researcher and clinician" Professor Philippe Hernigou, MD, Ph.D. The "approved" clinical study is said to have involved treatment of non-union bone injuries (specifically tibia fractures) using autologous stem cells, allogeneic stem cells and comparative traditional treatment therapies. The results presented to the company by Dr. Hernigou were said (by Company leadership) to be "exciting and profound ... in comparison to other traditional treatments". The year-long study is said to have included sixty patients and part of an on-going, ten year study involving nearly four hundred patients by Dr. Herningou using stem cell therapy and traditional treatment of non-union bones and joints. Stemedica has conculded the study gives "clear evidence that the use of adult stem cells provided greater healing capability in a shorter period of time with less infection". What is not clear whether anyone else will be granted the privilege of looking at the data. This begs a number of questions. Do they intend to publish? What was the study design? What kind of study was it? What is Stemedica's intent for this data?

Having previously ran into some trouble with a scandal associated with the Premier of Bermuda, the company is busily attempting to reinvent itself by distinguishing itself from those other international stem cell clinics claiming to treat a host of diseases for a fee without registered clinical trials, publications, etc.

Here's what we know. In addition to their US operation they have "facilities" in Moscow, Russia and Seoul, Korea. They also have partnership with a hospital in Tijuana, Mexico providing stem cell treatments for Alzheimer's, Parkinson's, Multiple Sclerosis, Muscular Dystrophy, Stroke, Ischemic Brain Trauma, Spinal Cord Injury and other neurodegenerative conditions and diseases. They say they only provide their stem cells to "hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies". They say their San Diego facility is "designed and constructed to be in compliance with appropriate FDA regulations including cGMP’s – Current Good Manufacturing Practice and GTP’s – Human Cells, Tissues and Cellular and Tissue-based products" and had CIRM leadership tripping over themselves recently after a visit their San Diego site to give the company and its facility glowing testimony (as reported in last week's blog). They say that they intend to conduct "future clinical studies in the United States".

Announcements like their recent proclamation of "exciting and profound" study results without publication are unlikely to dispel the critics that say this is more smoke masquerading as fire.

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Ok, this isn't "clinical" and I usually don't report on pre-clinical results but this one excites me and...it's my blog so skip to the next story if you don't wanna read it! (smile)

Opexa Therapeutics, Inc. (NASDAQ: OPXA) announced it has new preclinical data showing that cells obtained from peripheral blood of healthy and diabetic patients have the ability to differentiate - employing Opexa’s proprietary technology - into insulin-producing islet-like clusters demonstrating many of the expected characteristics of true pancreatic islet cells including the ability to secrete insulin, glucagon and somatostatin. Additional studies recently completed by Opexa’s scientists also reportedly support these findings showing high levels of C-peptide, a by-product of insulin synthesis, within these islet-like cells, as well as many key stem cell and pancreatic biomarkers. They also claim that in vivo studies involving the subcapsular kidney transplantation of these islet-like clusters into diabetic NOD/SCID mice resulted in a reduction in the blood glucose levels for prolonged periods of time.

Additional preclinical studies are planned to examine optimal dosing, delivery and route of administration of the islet-like clusters, and toxicology. Following a preliminary meeting with the FDA and through consultations with its Clinical Advisory Board, Opexa has designed a Phase I clinical study protocol. Primary endpoints are proposed to be safety of monocyte derived pancreatic-like islet cell transplantation and insulin independence or reduction in exogenous insulin requirements at one year post initial infusion.

COMMERCIAL

DNAmicroarray, Inc. in San Diego provides proprietary systems for controlling the differentiation of human stem cells. This is the low-hanging research tools business—the so-called shovels and blue jeans—to the scientists panning for gold. Still, while this is good business, DNAmicroarray president Babak Esmaeli-Azad told Xconomy San Diego editor, Bruce V. Bigelow, that he has also personally invested $2 million on internal stem cell research for potential therapies.

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Cryo-Save Group, the Netherlands-based stem cell company with a large Indian presence, plans to increase the number of stem cell donors in the country by opening more representative offices. Cryo-Save Group plans to invest €2 million (about Rs 13 crore) in its Bangalore-based subsidiary for over three years. Currently, the company is operating in Delhi, Mumbai, Pune, Ahmedabad and Bangalore. By the end of the year, they plan to open three additional centres, of which one will be in Kolkata, with a plan to expand into other South Asian countries by end of 2010. Cryo-Save currently charges Rs 75,000 per person to save a child’s umbilical cord blood and stem cells. This includes collection, processing and storing the cells for about 21 years.

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Just days after its purchase of Genentech, Roche has made another acquisition, albeit a much smaller one, of the German firm Innovatis. Roche has signed a definite agreement to buy the company for EUR 15 million. Innovatis provides automated cell analysis solutions, focusing particularly on cell counting, viability testing and cell function analysis in research and bioproduction. The deal is expected to be completed within the next few weeks.

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Lonza Group Ltd has announced that Anja Fiedler will replace Shawn Cavanagh as Head of Lonza Bioscience headquartered in Walkersville, MD. Anja Fiedler will become the new division head and member of the Lonza Management Committee (MC) as of 15 April 2009. Shawn, it is reported, "will leave the organization to pursue other interests". It does make one curious whether these other interests were what motivated him to leave or whether once he was shown the door we can only imagine he will now be motivated to find other interests. Whatever the case they did thank him for his dedication and wished him well in his future endeavors. Anja, curiously enough, comes to Lonza from outside the industry, most recently having been with Philip Morris. Is this a sign of more shake-ups to come as Lonza really starts to come to grips with its Bioscience acquisition now that it is fully integrated or is this just a one-off personnel changeup? Time will tell.

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The research tools sector - Life Technologies Corporation (NASDAQ:LIFE) and Sigma-Aldrich (NASDAQ:SIAL) in particular - are expected to report above estimated earnings given expected fallout of spending to occur from the Obama administration's recent decisions.

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Likely negotiating like its life dependended on it (oh ya, it does!), Isolagen, Inc. (Amex: ILE) has announced that the United States District Court for the Eastern District of Pennsylvania has issued an order granting preliminary approval of an agreement to settle its securities class action lawsuit and its two derivative actions against the Company and certain of its current and former officers and directors.

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BioLife Solutions, Inc. (OTC Bulletin Board: BLFS) announced that an independent European comparison of the Company's CryoStor pre-formulated serum-free and protein-free biopreservation media against traditional in-house formulated culture media/serum/DMSO showed CryoStor offers a significant cryopreservation process improvement and better cellular outcomes. Compared to media/serum/DMSO, CryoStor enabled enhanced post-thaw cell membrane integrity and a full recovery of metabolic activity and differentiation capacity within 24 hours after thawing. The study findings also confirm that despite improved cell recovery immediately after thawing for media/serum/DMSO cryopreserved cells beneath alginate, up to 50 percent cell death still occurred within 24 hours post-thawing.

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Early-stage venture capital firm OVP Venture Partners (OVP) announced today that distinguished scientist Irving L. Weissman, M.D., will join its technical advisory group. Is this a signal of their intent to invest in stem cell plays you think?

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RESOURCES & EVENTS

What am I your secretary? Find your own resources and events! Kidding... sorry I'm a little punchy today. I simply didn't come across anything to include here that I thought was sexy enough for this sexy edition of Cell Therapy Blog.

Sign-off

Ever wonder why Cell Therapy News now only carries advertising from Stem Cell Technologies? Did it ever seem curious to you that they never include news from competitors of Stem Cell Tech's?

Could it be that Cell Therapy Blog is your only source for independent and objective news and analysis in the cell therapy industry?

Help spread the word ...

Cell Therapy Industry HiLites 2009-03-06

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

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

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

And now, for the news and analysis ...

FINANCIAL

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

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

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

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

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

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

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

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

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

CLINICAL

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

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

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

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

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

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

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

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

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

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

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

COMMERCIAL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

RESOURCES & EVENTS

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

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

Registration is free, but space is limited.

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

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

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

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

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

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

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

Sign-off

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

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

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