Hana Biosciences (AMEX:HBX)
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Hana Biosciences (AMEX:HBX), a biopharmaceutical company
focused on advancing cancer care, today reviewed 2005 progress and
announced its corporate objectives for 2006.
Key 2005 achievements for Hana include:
-- Q1 05: Zensana(TM) pilot pharmacokinetic study demonstrated
pharmacokinetic profile comparable to oral Zofran(R), with
multidose convenience and faster drug delivery.
-- Q1 05: Initiated Talotrexin Phase I/II trial in non-small cell
lung cancer (NSCLC)
-- Q1 05: IPdR abstract/poster at the American Association for
Cancer Research (AACR) meeting demonstrated IPdR effective in
glioblastoma xenografts.
-- Q2 05: Began Talotrexin Phase I/II trial in adult
relapsed/refractory ALL (acute lymphocytic leukemia)
-- Q3 05: Began IPdR Phase I trial in colorectal, gastric, liver,
and pancreatic cancers
-- 2H 05: Commenced Zensana(TM) pivotal studies under 505(b)(2)
registration
-- 2H 05: Reported interim Talotrexin Phase I/II trial results in
NSCLC at AACR-EROTC
Key 2006 objectives for Hana include:
-- 1H 06: Announce results of Zensana(TM) pivotal studies
-- 1H 06: Announce results from Phase I clinical trials in NSCLC,
ALL, and solid tumors
-- 1H 06: Initiate Talotrexin Phase II trial in NSCLC, with
potential interim results in Q4 06
-- 1H 06: Initiate Talotrexin Phase II trial in other tumor type
-- 1H 06: Submit Zensana(TM) NDA under 505(b)(2) registration,
with potential US '07 market launch
-- 2H 06: Initiate additional Zensana(TM) clinical trials in
chemotherapy-induced nausea and vomiting (CINV)
-- 2H 06: Initiate additional IPdR Phase I/II trial in
glioblastoma multiforme (GBM) and/or neoadjuvant rectal cancer
-- 2H 06: Complete IPdR Phase I trial in gastric, colorectal,
pancreatic and liver cancers
"The Hana team made significant progress against the company's
2005 goals for all three clinical stage products. We are confident
that we will meet and exceed Hana's 2006 goals, including successfully
passing the milestones that will help us launch Zensana(TM)
commercially in 2007," said Mark Ahn, PhD, President and CEO.
Hana also announced that it intends to hold an annual shareholder
meeting and an analyst pipeline update teleconference on May 9, 2006,
during which the company intends to provide a review of all clinical
programs.
Product Pipeline Summary
Talotrexin (PT-523) is a novel nonpolyglutamatable antifolate drug
which has demonstrated enhanced antitumor activity in a broad spectrum
of cancers by targeting DHFR to prevent DNA synthesis and inhibit
tumor growth. Compared to currently available antifolates such as
methotrexate or pemetrexed (Alimta(R); Eli Lilly) in preclinical
studies, Talotrexin enters into cells up to 10-times more efficiently,
demonstrated 10 to 100 fold more potency by overcoming resistance by
remaining active in tumors by not requiring polyglutamation, and binds
more tightly to its anti-tumor target DHFR which enhances efficacy.
Thus, Phase I trial in solid tumors, Phase I/II trial in NSCLC
(non-small cell lung cancer), and Phase I/II trial in ALL (acute
lymphocytic leukemia) are ongoing. Phase II trials in cervical,
endometrial, and ovarian cancers are forthcoming.
Zensana(TM) (ondansetron oral spray) is a novel oral spray
formulation of ondansetron (Zofran(R);GlaxoSmithkline) that uses the
vast and highly-absorptive surfaces of the oral mucosa to deliver drug
directly into the blood stream to prevent chemotherapy, radiation and
post-operative induced nausea and vomiting. Taking pills for patients
experiencing nausea and vomiting can be problematic. Drug delivery via
the oral mucosa avoids degradation in the gastrointestinal tract and
metabolism by liver enzymes -- the so-called first-pass effect.
Zensana(TM) is being developed as a 505(b)(2) registration and targets
a 2007 launch in the US.
IPdR is a novel, orally available, thymidine analogue and prodrug
for IUdR, which demonstrated survival advantage in Phase II studies in
anaplastic astrocytoma, a type of brain tumor. Preclinical studies
have also demonstrated that IPdR has a dose responsive and synergistic
effect when combined with radiation in human glioblastoma models. IPdR
also showed superior safety and efficacy in comparison to IUdR, with a
significantly lower toxicity profile (lower gastrointestinal and
hematological side effects). IPdR is initially being developed in a
Phase I clinical trials for the treatment of colorectal, gastric,
liver, and pancreatic cancers. In addition, a Phase I/II clinical
trial in glioblastoma multiforme, a type of brain cancer, is planned.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (AMEX:HBX) is a South San Francisco,
CA-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, including the statements in this press release concerning
Hana's 2006 corporate goals and objectives, 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 Hana will achieve the goals and objectives outlined in
this press release or 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 these
statements, except as required by law.