Human BioSystems
Human BioSystems Scheduled to Meet with the FDA to Discuss Platelet Human Infusion Testing
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The issuer is solely responsible for the content of this announcement.
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Human BioSystems Scheduled to Meet with the FDA to Discuss Platelet Human
Infusion Testing
Palo Alto, CA – September 12, 2006 – (OTCBB:HBSC) Human BioSystems (“HBS”
or “Company”) 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.
Contact:
Human BioSystems Investor Relations Investor Relations
Harry Masuda Yes International Concept Communications, LLC
CEO Rich Kaiser James D. Caldwell
(650) 323-0943 (800) 631-8127 (727) 447-0514
hmasuda@humanbiosystems.com rich@yesinternational.com jc@conceptcg.com
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
(c)DGAP 14.09.2006
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