Hana Biosciences (AMEX:HBX)
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Hana Biosciences (AMEX:HBX), a South San Francisco-based
biopharmaceutical company focused on advancing cancer care, announced
today positive interim data from an ongoing, multi-center Phase I
clinical study evaluating single agent Talotrexin (PT-523) in relapsed
or refractory advanced non-small cell lung cancer (NSCLC). The
Talotrexin in Lung Cancer (TLC-1) study will be 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.
The multi-center, multinational study is an open-label, dose
finding study that seeks to determine the maximum tolerated dose
(MTD), dose limiting toxicities (DLT) and obtain preliminary objective
tumor response in NSCLC patients who failed at least two lines of
standard chemotherapy and/or an epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitor.
Study Results
Talotrexin was administered as a 5 minute intravenous infusion
(IV) on Days 1, 8 of a 21-day cycle with folic acid and B12 vitamin
supplementation. Eligible patients with ECOG performance status of 0-2
were administered increasing doses of Talotrexin. 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 have received a total of 50
cycles of Talotrexin (median 3, range 1-8) at doses of 27 mg/m2 to 270
mg/m2 per cycle. Thirteen patients had evaluable CT scans, and all
evaluated have failed previous platinum therapy. Talotrexin
administered on this schedule as a single agent has demonstrated
acceptable tolerability with encouraging activity in patients with
relapsed or refractory NSCLC. These interim results suggest:
-- Talotrexin was well tolerated over multiple cycles of therapy,
with mucositis, febrile neutropenia, and thrombocytopenia
being the most commonly reported adverse events. The MTD
remains to be determined in the ongoing study.
-- Clinical benefit in 10 (2 partial responses + 8 stable
disease) of 15 treated patients was observed in 67% of
patients after 2 or more cycles of Talotrexin in doses below
the MTD. One patient who previously failed pemetrexed
(Alimta(R)) has received 8 cycles of talotrexin therapy.
Median duration of PR and SD has not been reached.
-- Phase II studies in NSCLC are warranted and will commence
immediately upon the completion of the current safety and dose
finding study.
"We are encouraged about the activity of Talotrexin in this group
of heavily pre-treated non-small cell lung cancer patients," commented
Greg Berk, MD, Chief Medical Officer and Vice President of Hana
Biosciences. "This novel antifolate builds on a well established
mechanism of DHFR inhibition, and this preliminary clinical data
confirm what has been observed in preclinical models," noted Dr. Berk.
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."
About Talotrexin
Talotrexin is a novel nonpolyglutamatable antifolate drug which
has demonstrated improved antitumor activity in a broad spectrum of
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, 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.
Two additional early phase dose finding clinical trials are
underway: Phase I trial at the Dana Farber Cancer Institute (DFCI) in
patients with solid tumors; and a Phase I/II multi-center trial in
relapsed or refractory acute lymphocytic leukemia. Additional phase II
trials in cervical, endometrial, ovarian cancers are forthcoming.
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-KSB for the year ended Dec. 31,
2004. Hana assumes no obligation to update these statements, except as
required by law.