Hana Biosciences Initiates Talotrexin Phase II Clinical Trials in Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
31 Mars 2006 - 2:03PM
Business Wire
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.
Hana Biosciences (AMEX:HBX)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Hana Biosciences (AMEX:HBX)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024
Real-Time news about Hana Biosciences (American Stock Exchange): 0 recent articles
Plus d'articles sur Hana Biosciences, Inc.