Hana Biosciences (AMEX:HBX)
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Completed Phase I Results to Be Presented at American Society of
Clinical Oncology (ASCO) Meeting to Be Held June 2-6, 2006 in Atlanta
Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused
on advancing cancer care, announced that the company initiated a
multicenter, multinational Phase II clinical trial with Talotrexin
(PT-523) in relapsed or refractory non-small cell lung cancer (NSCLC).
The primary objective of this Phase II portion of an ongoing Phase
I/II open-label study is to demonstrate an improvement in overall
survival. Secondary objectives are evaluation of safety, overall
response rate, time to progression, and progression free survival.
Relapsed or refractory NSCLC patients who have failed at least two
lines of treatment including standard chemotherapy and/or an epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitor are eligible
to enroll in the study. Patients who meet all eligibility criteria
will receive Talotrexin on a 21-day cycle. Myelosuppresion and
mucositis were the dose limiting toxicities of the Phase I portion of
the trial that determined the recommended Phase II dose of Talotrexin
in this setting. Updated clinical trial data will be presented during
the 42nd Annual American Society of Clinical Oncology (ASCO) meeting
in Atlanta, June 2-6, 2006.
"Advancing into Phase II is an exciting step forward in the
development of Talotrexin as a potential therapy for heavily
pre-treated non-small cell lung cancer patients," noted Greg Berk, MD,
Chief Medical Officer and Senior Vice President, Hana Biosciences.
Jennifer Garst, MD, Assistant Professor of Medicine at Duke
University, and an investigator on the trial commented, "Antifolates
clearly have a role in the management of advanced non-small cell lung
cancer. These preliminary data are encouraging and support taking this
drug into the phase II setting."
Summary of Reported Interim Phase I Results in NSCLC
Previous positive interim Phase I data from this study evaluating
single agent Talotrexin in relapsed or refractory advanced non-small
cell lung cancer (NSCLC) was 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, Pennsylvania on November 16, 2005.
Talotrexin was administered as a 5-minute intravenous infusion
(IV) on a 21-day cycle. Eligible patients with an ECOG performance
status of 0-2 were administered increasing doses of Talotrexin during
the study. Tumor response and disease progression relative to baseline
was evaluated using the Response Evaluation Criteria in Solid Tumors
(RECIST) methodology. Toxicity was graded using the National Cancer
Institute Common Toxicity Criteria (NCI-CTC). At this interim
analysis, 15 patients had received a total of 50 cycles of Talotrexin
(median 3, range 1-8) at doses from 27 mg/m2 to 270 mg/m2 per cycle.
Thirteen patients had evaluable CT scans, and all evaluated patients
had failed previous platinum therapy. Talotrexin administered on this
schedule as a single agent demonstrated acceptable tolerability and
encouraging results in patients with relapsed or refractory NSCLC.
Interim results suggested:
-- Talotrexin is well tolerated over multiple cycles of therapy,
with myelosuppresion and mucositis the dose limiting
toxicities.
-- Clinical benefit in 67% or 10 (2 partial responses (PR) + 8
stable disease (SD)) of 15 treated patients was observed in
patients after 2 or more cycles of Talotrexin. One patient who
previously failed pemetrexed (Alimta(R)) has received 7 cycles
of Talotrexin therapy. Median duration of PR and SD has not
been reached to date.
About Talotrexin
Talotrexin is a novel nonpolyglutamatable antifolate drug which
has demonstrated improved antitumor activity in a broad spectrum of
preclinical cancer models by targeting dihydrofolate reductase (DHFR)
to prevent DNA synthesis and inhibit tumor growth. Compared to
methotrexate in preclinical studies, Talotrexin enters into cells up
to 10-times more efficiently and demonstrates 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. Talotrexin is currently being
evaluated in two additional clinical trials: a Phase I trial in
patients with solid tumors; and a Phase I/II multi-center trial in
relapsed or refractory leukemias. Detailed information regarding these
ongoing trials can be accessed at www.hanabiosciences.com. Additional
trials in cervical and gastric cancers are planned.
About Non-Small Cell Lung Cancer (NSCLC)
According to the World Health Organization, there are more than
1.2 million cases worldwide of lung and bronchial cancer each year,
causing approximately 1.1 million deaths annually. It is estimated
that more than 173,000 people will be diagnosed with lung cancer in
the United States in 2005. According to the National Cancer Institute,
lung cancer is the single largest cause of cancer deaths in the United
States and is responsible for nearly 30 percent of cancer deaths in
this country. NSCLC is the most common form of the disease and
accounts for more than 80 percent of all lung cancers. Despite recent
therapeutic advances in NSCLC, the overall survival remains poor and
there is a need for improved treatments.
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 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-K for the year ended Dec. 31, 2005.
Hana assumes no obligation to update these statements, except as
required by law.