Scimitar Equity Blog

Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas.  OSIR’s  Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease.  Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.

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The objective of the filed IND Application is to start a Phase I/II study at multiple centers. The study would involve the use of retinal cells, which have been developed from the stem cells of the embryo for the treatment of patients suffering Stargardt’s Macular Dystrophy (SMD).

As stated in our blog/post of 2/22/10:  “The NIH is … expanding its definition for what constitutes a human embryonic stem cell as acceptable lines for federal funding… If approved, it would be among the 1st clinical tests of embryonic stem cells.  As proposed in the Federal Register, the new definition will cover “early stage embryos up to and including the blastocyst stage”.   The NIH, in changing the definition, explicitly acknowledged that ACTC.OB’s application contributed to the decision.

The ruling, which will have limited impact for the overall stem cell industry, carries broad implications for ACTC.OB; essentially, re-writing its definition.

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Bioheart (BHRT.OB) is a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic, acute heart damage, and peripheral vascular disease.  BHRT.OB initiated its REGEN trial, a Ph I clinical trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). BHRTs  MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells that are grown from a patient’s own muscle.  MyoCell® has been tested successfully on patients in four clinical trials. The REGEN trial is designed to test the safety and effectiveness of a composition of muscle stem cells that have been gene-modified to induce a greater than usual release of the SDF-1 protein.

The REGEN trial is being funded by 1 of the BHRT.OB’s institutional investors (Ascent Medical Technology Funds).  CRO,  Biomed Product Development Centre will be managing  the study that is being conducted in Jordan.

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ISCO.OB is focused on using hpSC to treat severe diseases of the eye, the nervous system and the liver where cell therapy has been proven … clinically … yet is limited by the availability of safe immune-matched human cells. ISCO.OB is about to demonstrate the therapeutic applicability and potential immune rejection advantages of hpSC lines relative to other stem cell classes. Its new production facility for clinical-grade stem cell products has passed final building inspection consisting of separate suites to further develop and produce different cell types from the their human parthenogenic stem cell (hpSC) technology.  These parthenogenetic stem cells have the medical advantage of allowing immune-matching to large segments of the population and the ethical advantage of not requiring the use of human embryos.

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Stem cell surgery options and procedures continue to evolve at a rapid rate and companies such as Cytori Therapeutics are making preparations to serve more medical centers and cosmetic surgery facilities with stem cell orders in the oncoming years. Most recently, Cytori has received an order for a StemSource Cell Bank from Cosmetic Surgery Seishin in Japan.  The order request is for the patented Cell Bank which includes a complete StemSource processing system, equipment, software, a database, and protocols needed to freeze and preserve patient’s adipose-derived stem cells.  This StemSource Cell Bank allows doctors to use adult regenerative cells that are extracted directly from the patient’s adipose tissue, and use them in procedures such as stem cell breast augmentation, skin resurfacing procedures, and facial plastic surgery procedures that demand rapid regeneration of cells and skin tissue.

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Results emanated from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BTIM’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study reported that initial resuscitation with Hextend was associated with NO obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.  However, study principals cautioned that their “…study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial”. Results showed that overall mortality for the patients treated with Hextend was significantly lower at 5.2 % compared to 8.9 % for the patients receiving fluid resuscitation without Hextend.  NO other study has evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies  in various other types of surgical patients.

Hextend is a formulation of 6% hetastarch combined with a physiologically balanced crystalloid carrier that more closely mirrors plasma electrolyte balance than 6% hetastarch in 0.9% sodium chloride.

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The turmoil in the last 2-3 weeks markets makes it hard sometimes to focus GERN’s short-term share price appreciation.  An expanding indication for GRNOPC1 is good news as the FDA placed a clinical hold on the early-stage trial of this compound. The outstanding warrant exchange accounting for approximately 3/4 of all warrants strengthened the balance sheet with GERN selling additional shares of common to investors at a premium for gross proceeds of $10 M, generating a 2.7 M shares lock-up provision with the new block of shares being purchased and issuance of a call option to the investors to purchase an additional $5 M of common stock.  Adding to the these events,  the GRN163L  compound is being tested on human cells and on rodents showing very striking results; attacking not only the bulk of the tumor cells, but also the rare cancer stem cells that are believed to be responsible for most of a cancer’s growth.

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Results from Cytori Therapeutics’ preclinical fat grafting study have been published in the February issue of the Annals of Plastic Surgery. This article, entitled “Supplementation of Fat Grafts with Adipose-Derived Regenerative Cells (ADRCs) Improves Long-Term Graft Retention,” examines the science behind cell-enriched autologous fat grafting and its application to cosmetic and reconstructive surgery.

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There are 337 (276 public and 61 private) lifescience companies presenting starting Monday, 1/11 and running through Thursday, 1/14. Link:  JPMHealthcareConference-Agenda1.7

Public company presentations are usually web-cast enabling non-participants to view presentations with breakout sessions immediately following their presentations. These web-casts will be available for 3 months after the conference: https://events.jpmorgan.com/ ; so click on the web-cast link (no need for a user name and password but will be prompted an email address). As related to current economic times, registration of attendees was limited by JP Morgan to a total of about 3,500 versus 6,000 in the past years.

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Advanced Cell Technology (ACTC.OB or ACT) filed an Investigational New Drug (IND) application on 11/18/09 to conduct a PI/II trial using hESCs to treat a genetic eye disease.

• The “proposed” trial aims to treat patients with Stargardt’s Macular Dystrophy (SMD);  a genetic eye disease for which there is currently – NO – treatment and one of the most common causes of “juvenile” blindness,
• The disease results in the degeneration of the retinal pigment epithelium (RPE) cells that support the photoreceptors needed for vision — which in turn causes the degeneration of the photoreceptors and leads to vision impairment.

Bottom Line: Referencing our post on 10/27/09;  ACTC.OB “proposes” to transplant hESCs that have been “differentiated” into retinal pigment epithelial cells into SMD patients in hopes of improving visual acuity. Previous work at ACT has shown dramatic improvement in the visual performance of animal models that received implants of these differentiated RPE cells according. Furthermore, they had found no adverse effects (such as teratomas) in hundreds of treated animals and the cells are “almost 100%  RPE”, meaning there are virtually no undifferentiated cells that “could” potentially behave “differently” after implantation.

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