Hana Biosciences Announces Positive Interim Results From a Phase I Trial of Talotrexin (PT-523) in Relapsed or Refractory Non-Sm
November 14 2005 - 7:58AM
Business Wire
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.
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