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Hana Biosciences Initiates Marqibo(R) Phase 2 Clinical Trial in Relapsed Acute Lymphoblastic Leukemia (All)

04 Aug 2007

Hana Biosciences today announced the initiation of a multi-center, multi-national Phase 2 clinical trial of Marqibo(R) (vincristine sulfate injection, OPTISOME(TM)) in adult patients with relapsed acute lymphoblastic leukemia (ALL), also known as the rALLy study

SOUTH SAN FRANCISCO, CA, USA | August 3, 2007 | Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused

on advancing cancer care, today announced the initiation of a multi-center, multi-national Phase 2 clinical trial of Marqibo(R) (vincristine sulfate injection, OPTISOME(TM)) in adult patients with relapsed acute lymphoblastic leukemia (ALL), also known as the rALLy study. Earlier this year, Marqibo was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of adult ALL.

"Adults with relapsed ALL have very few options for effective therapy. Based on earlier trials in ALL and non-Hodgkin's lymphoma, Marqibo's unique pharmacokinetic profile may result in an improvement in tumor response with a more tolerable drug profile for ALL patients," said Susan O'Brien, M.D., Professor in the Leukemia Department at the University of Texas MD Anderson Cancer Center in Houston, and the principal investigator for the rALLy study.

The primary objective of the rALLy study is to assess the efficacy and tolerability of weekly doses of Marqibo as a single agent without dose capping, measured by complete response (CR) rate or complete response without full platelet recovery (CRp). Secondary objectives include evaluation of safety, duration of CR/CRp, and survival. The patient population is defined as Philadelphia chromosome-negative adult patients in second relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation. In this trial Hana expects to enroll up to 56 patients.

"We are encouraged by the existing clinical trial data for Marqibo in relapsed ALL that showed a promising response rate in this difficult-to-treat and heavily pretreated patient population," stated Steven R. Deitcher, M.D., Executive Vice President of Development and Chief Medical Officer of Hana Biosciences. "Based on our recent contacts with the FDA, we believe that we have designed an important relapsed ALL study and overall Marqibo development plan that will yield convincing results and bring us closer to making this treatment available to patients in a timely fashion."

The company also plans to initiate a Phase 3 randomized, multi-center trial comparing Marqibo to vincristine in the induction, consolidation, and maintenance phases of treatment in elderly patients with newly diagnosed ALL. Hana expects the Phase 3 clinical trial to be conducted in collaboration with U.S. and the ex-US oncology cooperative groups.

About Marqibo(R) (vincristine sulfate injection, OPTISOME(TM))

Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, and melanoma in several trials. Vincristine, a microtubule inhibitor, is FDA-approved as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine kills cancer cells when they enter a very specific point in the cell cycle, and its efficacy is concentration- and exposure duration-dependent. Marqibo is believed to extend the circulation time of vincristine in the bloodstream, increase targeting of the drug to the malignant disease, and enhance exposure duration at the site of the disease. Unlike regular vincristine, Marqibo is dosed based on patient body surface area without the need to cap the dose.

About Acute Lymphoblastic Leukemia (ALL)
Approximately 4,000 cases of ALL are diagnosed annually in the United States. While cure rates for childhood ALL have steadily improved to nearly 90 percent, adult ALL reported cure rates seldom exceed 40 percent. The poorer outcome in adult ALL has been attributed to an increased frequency of high-risk leukemia with greater resistance, poorer tolerance of and compliance with treatment, reluctance to accept toxic effects, and less effective treatment regimens as compared with childhood ALL. Currently, there are no fully-approved agents for adult Philadelphia chromosome negative ALL salvage, nor is there a consensus on the most appropriate regimen in the relapsed setting. Ongoing efforts are needed to investigate agents for this indication, as well as incorporate active agents, once identified, into front-line therapy.

About OPTISOME(TM) Nanoparticle Technology
Optisomes are a new generation of unique sphingomyelin/cholesterol-based nanoparticles designed to encapsulate cell cycle-specific chemotherapeutics designed for improved efficacy with reduced toxicity. Optisomes are approximately 100 nanometers in diameter and able to encapsulate and transport cancer drugs preferentially to tumor sites. While too large to easily migrate out of normal blood vessels, Optisomes are able to migrate across the more "leaky" vasculature of a tumor, resulting in higher concentrations of drugs at tumor sites than in normal tissue.

Optisomes' unique sphingomyelin-cholesterol composition is particularly well suited to cell cycle-specific agents such as vincristine, vinorelbine and topotecan. The relative rigidity of the Optisomes' outer shell results in a long circulating half-life and sustained drug release at the tumor site, which may increase tumor cell exposure during the most vulnerable phases of cell division. Combined, these factors are key to the Optisome advantage as sustained drug exposure increases tumor cell death. Hana's Optisome pipeline includes Marqibo(R) (vincristine), Alocrest(TM) (vinorelbine) and Optisomal topotecan.

About Hana Biosciences, Inc.
Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing 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. These statements are often, but not always, made through the use of words or phrases such as ``anticipates,'' ``expects,'' ``plans,'' ``believes,'' ``intends,'' and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates, including its Marqibo product candidate. 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 other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.

SOURCE: Hana Biosciences, Inc.

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