Message #9 From:
NewsBot Date: September 12, 2006 01:05:00 PM
HBSC News Human BioSystems Scheduled to Meet with the FDA to Discuss Platelet Human Infusion Testing
PALO ALTO, Calif.--(BUSINESS WIRE)--Sept. 12, 2006--Human BioSystems ("HBS" or "Company") (OTCBB:HBSC) announced today that a pre-IND (Investigational New Drug) application meeting with the FDA (Food and Drug Administration) has been scheduled for early October to discuss HBS's plan to conduct human infusion tests using the Company's patented platelet preservation system.
The Pre-IND meeting is a prelude to a formal application and request to proceed with human testing once all concerns and requirements of the FDA are satisfied. The planned studies will involve a number of human subjects that are infused with platelets stored in the cold using the HBS process and compared to platelets prepared using the current storage method. The platelets are uniquely labeled prior to infusion to distinguish the HBS platelets from the control group, and monitored for platelet survival in the bloodstream over time.
Dr. David Lucas, Director of Platelet Development for HBS stated that "Studies have shown that standard blood platelets stored in the cold for 24 hours or longer are not functional and are quickly eliminated from the blood after infusion. It is our goal to show that HBS platelets will maintain functionality and continue to circulate in the bloodstream for more than a few hours and ideally even for days after infusion. The HBS platelets will be stored at refrigerated temperatures for several days prior to infusion."
The advantages of the HBS cold stored platelets are potentially longer shelf life, fresher and higher quality platelets, cost savings due to fewer platelet transfusions and significant savings of expenses due to the reduction of outdates compared to platelets stored under current methods.
Dr. David Winter, President of HBS confirmed that "The basis for proceeding to human infusion studies is the result of positive in-vitro test data obtained at two independent research centers in the United States. This Pre-IND meeting is a positive step toward our goal to demonstrate that cold stored platelets using HBS technology can maintain functionality after storage for more than 24 hours, which to our knowledge, has never been demonstrated before."
Blood platelets are the congealing component in blood, and are an essential part of the treatment for cancer patients who have undergone chemotherapy. Current regulations provide for the storage of platelets at room temperature for 5 days.
Human BioSystems is a developer of preservation platforms for organs and other biomaterials. The Company, which is headquartered in Palo Alto, California with research facilities in Michigan, has made significant progress in its nine-year history. This scheduled meeting is another milestone for Human BioSystems in achieving its goal to commercialize its technologies.
Certain statements contained herein are "forward-looking'' statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, results from ongoing research and development as well as clinical studies, failure to obtain regulatory approval for the Company's products, if required, failure to develop a product based on the Company's technology, failure of any such products to compete effectively with existing products, the inability to find a strategic partner or to consummate a relationship with a potential strategic partner on acceptable terms, and other factors discussed in filings made by the Company with the Securities and Exchange Commission
