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Tuesday, March 17, 2009

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.


Cell Therapy Blog wants your ad. If you're looking to get high-impact and lasting exposure to those in the cell therapy industry...

Contact Lee [at] celltherapygroup [dot] com


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 or reply to me.

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


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.


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 .


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.



While desperately looking for enough cash to last beyond mon
th'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.


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.

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.


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.


Ok, this isn't "clinical" and I usually don't report on pre-clinical results but this one excites me'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.


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.


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.


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.

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.


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.


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.

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.


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?



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.


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1 comment:

Frog said...


I had the opportunity to play golf with a couple senior Lonza-Walkersville folks yesterday on beautiful day. My take is that Sean left of his own accord and they were looking forward to the new boss.

I didn't think it was newsworthy until reading it here. Just like finding out Bruce Ivins' had committed suicide a week before the LA Times story broke. I should never quit my day job to be a reporter.