Hana Biosciences Announces Positive In Vivo Preclinical Results Confirming Pharmacokinetics of Zensana(TM) (Ondansetron Oral Spr
17 Novembre 2005 - 6:07PM
Business Wire
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.
Hana Biosciences (AMEX:HBX)
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