New NIH Common Fund
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. These programs are all scheduled to begin during FY10. The research programs will distribute $17.8 M in NIH Common Fund support in FY10 and additional funds in future years. These projects capitalize on emerging scientific opportunities and technology advances to fuel biomedical discovery, strengthen the biomedical community nationally and globally and hasten the translation of science discoveries into new and better treatments.
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.
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. These investments provide BCLI.OB with the necessary funds to conduct its upcoming Phase I/II ALS clinical trial with a collaborative agreement with Hadassah Medical Center to conduct its ALS clinical trials at the Hadassah Ein Kerem Hospital, Israel.
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).
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, priced at a 30% premium over the market on the closing, with an approximate $3.7 M from warrant exercises. CUR has also received notice from the NYSE Amex that the CUR is now in compliance with its listing requirements. These funds will help to support the further development of its stem cell technology and the ongoing Ph I ALS clinical trial.
The resulting effect of the reverse stock split is that every 8 shares of the issued/outstanding common stock prior to the opening of trading will be combined into 1 issued without any change in the par value of shares with the number of authorized but unissued shares of the common stock proportionally reduced. As a result, ASTM (D) could have approximately (rough calculation) 30 M shares outstanding with a total fully diluted value of 40 M including warrants and options.
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.
STEM announced its proprietary HuCNS-SC® human neural stem cells have been used to treat the first patient enrolled in its Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that afflicts male children. The stem cells were administered at the University of California (UCSF) Children’s Hospital by direct injection into the brain of a patient with connatal PMD and the most severe form of the disease. This marks the first time that neural stem cells have been transplanted as a potential treatment for a myelination disorder, and the second clinical trial involving the use of HuCNS-SC cells in a neurodegenerative disease.
ReNeuron (LON: RENE) has been … finally … given full regulatory approval by the UK Gene Therapy Advisory Committee to initiate a stem cell trial for ischemic stroke after a 5 years approval cycle.
ASTM continues its cardiovascular clinical programs and expects to aggressively to advance these programs in 2010. Net loss was $4.575 M or $.03 per share. Total revenues were $16 K. Total costs and expenses were $4.6 M. R&D expenses increased to $3.283 M (reflecting continued expansion of clinical development activities and share based compensation expense). G&A expenses decreased to $1.316 M (due to an offset of stock compensation expense). At 12/31/09, the company had $14.7 M in cash. Post the completion of the public offering 1/10 ($12.4 M in net proceeds), ASTM now has $25.5 M in cash. The burn rate should average $1.4 M per month. Timing is everything, at this share price ($0.18 with a Mtg Cap of $31.49), the new CEO’s vision will be better articulated and focused!