Hana Biosciences (AMEX:HBX)
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Hana Biosciences (AMEX: HBX):
-- Results confirm potential of Zensana(TM) (ondansetron oral
spray) as the first oral spray 5-HT3 antagonist to deliver
full doses of ondansetron faster and more conveniently than
tablets
-- Pivotal clinical trials for 505(b)(2) registration to commence
in December 2005
-- U.S. commercial launch targeted for 2007
Hana Biosciences (AMEX: HBX), a South San Francisco-based
biopharmaceutical company focused on advancing cancer care, announced
positive data from a completed preclinical in vivo pharmacokinetic
study comparing different formulations of Zensana(TM) (ondansetron
oral spray) with commercially available ondansetron solution
(Zofran(R); GlaxoSmithKline).
Results from the study, in male beagles, were presented at the
American Association for Cancer Research-National Cancer
Institute-European Organisation for Research and Treatment of Cancer
(AACR-NCI-EORTC) International Conference on Molecular Targets and
Cancer Therapeutics in Philadelphia.
The study demonstrated enhanced bioavailability of Zensana(TM)
versus currently approved ondansetron solution with a 7- and 9-fold
increase in area under the concentration time curve (AUC). In
addition, both ondansetron sprays demonstrated peak concentrations
(Cmax) approximately four times greater than ondansetron oral
solution. Time to peak concentration (Tmax) of both formulations
demonstrated similar to 45% faster absorption versus the oral
solution. Both oral sprays were well-tolerated.
These results are consistent with an earlier pilot clinical trial,
as well as other models, where administering drugs through the highly
vascularized tissues surrounding the buccal and oral mucosa delivers
improved systemic absorption and the potential for faster onset of
action. Hana Biosciences licensed Zensana(TM) from NovaDel
Pharmaceuticals (AMEX: NVD) for the United States and Canada.
"Pharmacokinetic results from this study further build on a body
of clinical and preclinical evidence which support the further
development of Zensana(TM) in the clinical setting," stated Greg Berk,
M.D., chief medical officer and vice president of Hana Biosciences.
"We look forward to initiating pivotal clinical studies designed to
explore the potential of Zensana(TM) as a new and convenient
alternative formulation for treating nausea and vomiting associated
with chemotherapy."
About Zensana(TM) (Ondansetron Oral Spray)
Zensana(TM) (ondansetron oral spray) is the first oral spray 5-HT3
antagonist. It conveniently delivers full doses of ondansetron faster
than tablets to patients receiving emetigenic chemotherapy. Zensana
allows patients to gain and maintain protection from chemotherapy,
radiation and post-operative induced nausea and vomiting.
Patients experiencing nausea and vomiting have difficulty
swallowing and holding down pills. Drug delivery via a spray to the
oral mucosa is more convenient and avoids degradation in the
gastrointestinal tract and metabolism by liver enzymes -- the
so-called first-pass effect. Zensana(TM) oral spray is simple to take
and insures patients receive a full dose of protection from
chemotherapy-induced nausea and vomiting. Zensana(TM) is being
developed as a 505(b)(2) registration, will commence pivotal trials by
the end of 2005, and targets a 2007 launch in the United States.
About Hana Biosciences Inc.
Hana Biosciences Inc. is a South San Francisco, Calif.-based
biopharmaceutical company that acquires, develops, and commercializes
innovative products to advance cancer care. The company is committed
to creating value by building a world-class team, accelerating the
development of lead product candidates, expanding its pipeline by
being the alliance partner of choice, and nurturing a unique company
culture. Additional information on Hana Biosciences can be found at
www.hanabiosciences.com.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
statements involve risks and uncertainties that could cause Hana's
actual results to differ materially from the anticipated results and
expectations expressed in these forward-looking statements. These
statements are based on current expectations, forecasts and
assumptions that are subject to risks and uncertainties, which could
cause actual outcomes and results to differ materially from these
statements. Among other things, there can be no assurances that any of
Hana's development efforts relating to its product candidates will be
successful. Other risks that may affect forward-looking information
contained in this press release include the possibility of being
unable to obtain regulatory approval of Hana's product candidates, the
risk that the results of clinical trials may not support Hana's
claims, Hana's reliance on third-party researchers to develop its
product candidates, and its lack of experience in developing
pharmaceutical products. Additional risks are described in the
company's Annual Report on Form 10-KSB for the year ended Dec. 31,
2004. Hana assumes no obligation to update thing statements, except as
required by law.