GERN reported a Q4/09 net loss of $18.4 M, or $0.20 a share based on higher operating expenses. FY09’s loss was $70.4 M, or $0.80 a share.
Programs to create a new center for the study of stem cells and to increase capacity to deal with global health issues were among 7 scientific initiatives announced 2/25/10 by NIH Director Francis S. Collins, MD, PhD. The 7 research programs are supported through the NIH Common Fund, which encourages collaborative research programs across the NIH institutes and centers (IC) to accomplish work that no single IC could do alone. Read more…
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), 2/24/10 unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The initiative involves 2 interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.
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.
Aastrom reported results from interim analysis of the multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. According to the interim analysis the safety profile was similar between the treatment and placebo arms. Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), ASTMD’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound closure) approached but did not reach statistical significance at interim analysis.
BCLI.OB announced that it has entered into agreements with 3 investors with each investing $500 K for a total of investment of $1.5 M with issuance to each of 3 investors, 2 M shares of stock based on the 30 day average share price as of 2/11/10 of $0.25 per share and 1 M warrants with an exercise price of $0.50 per share for a total issuance of 6 M shares and 3 M warrants. Read more…
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).
ACTC.OB appreciated (+ $0.014) 15.73 % on 2/22/10, with 18.5 M shares traded … after the National Institutes of Health (NIH) stated (over the weekend) that it was slightly expanding its definition for what constitutes a human embryonic stem cell as acceptable lines for federal funding. This NEW proposal will benefit several academic researchers and ACTC.OB, that has filed a request with the FDA to test a treatment for macular degeneration, an eye disease. If approved, it would be among the 1st clinical tests of embryonic stem cells. Read more…
RENE.LON announced that it has raised (GBP) £4.7 M (before expenses), from existing and new institutional shareholders issuing/selling 94,400,000 new shares. The 1st closing for 16,800,000 is expected on 3/18/10 and the 2nd closing for 77,600,000 is expected on 3/19/10. The net proceeds will provide RQE.L to satisfy its burn rate for at least the next 12 months. The net proceeds will further the Phase I trial ReN001, a stem cell therapy for disabled stroke patients, pre-clinical testing of ReN009 therapy for peripheral arterial disease and optimization/scale-up of the 2nd generation CTX stem cell line as well as providing for general working capital purposes.
Neuralstem has raised a total of $5.228 M improving its financial position finalizing a $1.5 M private placement of 646,551 common shares at $2.32, Read more…
Founder and Director of Research, Henry McCusker enters his eighth (8) year at Scimitar Equity with past experience in sell-side analysis, buy-side management, corporate management and due diligence.