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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International Stem Cell Corporation (NASDAQ:ISCO.OB) is a biotech focused on therapeutic and research products.
- ISCO.OB develops pluripotent stem cells that are comparable in function to embryonic stem cells from which cells for human transplant are derived; and techniques to cause those cells to be differentiated into the specific cell types required for transplant, as well as manufactures protocols to produce these cells without contamination with animal by-products.
Focus: ISCO.OB creates human cells for the treatment diabetes, liver disease, corneal disease, and retinal disease through cell transplant therapy, as well as engages in the development of therapeutic products. Read more…
ReNeuron is a UK-based stem cell company. Their primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need. RENE.L’s shares are traded on the London AIM market.
Focus: ReNeuron’s stem cell products are derived from non-embryonic human tissue sources. RENE.L’s stem cell therapy program have been built around stem cell expansion technology, c-mycER. This platform enables, from a single tissue sample, the growth of selected human stem cells into banks of quality-assured stem cell lines. These stem cell lines contain enough stem cells to treat many thousands of potential patients. This capability has enabled RENE.L to focus on developing non-patient-specific or allogeneic, stem cell treatments addressing diseases with large patient populations. The stem cell expansion process is fully regulated by way of a chemically induced safety switch so that cell growth can be arrested before implantation of the stem cells into the patient.
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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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Cytori Therapeutics received U.S. Patent No. 7,651,684 (the ‘684 patent) which covers the CYTX’s methods for delivering adipose-derived stem and regenerative cell-enriched fat grafts into patients. The ‘684 patent specifically covers cell-enriched fat grafts to treat soft-tissue defects and urinary incontinence. In addition, the ‘684 patent covers methods for delivering cell-enriched fat grafts to a patient’s breast, wrinkles, lips, under the eyes, cheeks, chin, and other parts of the body and broadens current expansive patent portfolio covering adipose-derived cell therapies.
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MultiCell Immunotherapeutics specializes in developing primary liver cell immortalization technologies to produce cell-based assay systems for use in drug discovery by leveraging patented technology and expertise to develop therapeutics to treat serious diseases including multiple sclerosis, type-1 diabetes, and infectious disease.
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The public offering/ financing further strengthened its’ balance sheet and to complete ongoing Phase II clinical trials:
- Receiving approximately $12.4 M from the sale of units including the over-allotment,
- The 52,077,100 units consisted of 52,077,100 shares of common stock, Class A Warrants to purchase an aggregate of 39,057,825 shares of common stock and Class B Warrants to purchase an aggregate of 26,038,550 shares of common stock,
- Each Class A Warrant entitles the holder to acquire 1 share of common stock upon payment of $0.3718 per share, exercisable for a 5 year period commencing on a date 6 months after the closing date and each whole Class B Warrant entitles the holder to acquire 1 share of common stock upon payment of $0.26 per share, exercisable for a 6 month period,
- The public offering format was better then a PIPE or an RDO as retail investors could participate,
- The stock tumbled to $0.23 after ASTM priced the offering at $0.26 a share,
- The GOOD news … the “pre-baked” offering was over-subscribed … as a few investors could not get in,
- The offering was done at $0.26 while the stock was trading lower, now at $0.236, up $0.007 and continuing to … edge-up,
- Investors (and ME) should have realized something was in the air when ASTM amended (12/09) its Restated Articles of Incorporation that increased the authorized shares of common stock from 250 M to 500 M,
- The fully diluted value is heavy with approximately 230 M (+) of outstanding shares plus warrants plus the incentive options,
- But, the reverse is … still … DUE … to eliminate by 3/31/10 the NASDAQ listing issue,
- So, the question is creating a share price balancing act of appreciation to the future,
- News is the … only factor as interim clinical data from its cardiac and limb ischemia trials are due,
- The pure risk benefit … made sense … unfortunately price depreciation was inevitable … as in biotech, dilution is a constant,
- The REAL choice was the value of money, now or later,
- However, the proxy vote for the reverse split defined a range of 5 to 8 for 1,
- We can all multiply the current price against/with the current price but no one wants a post-reverse sell-off,
- Responding to our 1/15/10 post: the new CEO, Tim Mayleben deserves credit for a big and bold move … with this market slipping as it has: he raised $$, added a few institutions/hedge funds but, the piper (reverse) still has to be paid,
- Ranked a … BUY … as still below the offering pricing and news is due.
Over 6000 people piled into the Westin St. Francis Hotel in San Francisco for the 28th Annual Conference. Investors, Company presenters and entrepreneurs were emboldened by good biotech sector returns in 2009 of 18-28% with many stocks reaching new highs. Seasonality has been a factor with the so-called “January effect” where small cap stocks tend to spike up due to a number of factors but this Conference has been paramount. For example the IBB ETF is up about 6% from November levels.
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Access Pharma (OTC: ACCP.OB) provided an update today on the status of its cobalamin-based oral drug delivery product development programs. The BioMedReports.com research downloads section and the ProActive News Room website for Access both contain the most recent research reports and presentation for the Company, following its presentation last week at the OneMed Forum in San Francisco, which was held in conjunction with the JP Morgan Healthcare Conference.
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