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Hana Biosciences today announced that the pre-specified response criteria to proceed to full enrollment of 56 patients has been achieved in its pivotal clinical trial of Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse
SOUTH SAN FRANCISCO, CA, USA | September 9, 2008 | Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the pre-specified response criteria to proceed to full enrollment of 56 patients has been achieved in its pivotal clinical trial of Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse.
Five out of the first 20 patients who completed at least one cycle of weekly Marqibo treatment achieved a complete response (CR) or CR without full platelet (CRp) or neutrophil (CRi) recovery based on interim data. Of the 5 patients, 4 achieved a CR or CRp and the fifth patient achieved a CRi and underwent subsequent stem cell transplantation (SCT) prior to confirmatory bone marrow examination. In total, 3 of the 5 patients underwent potentially curative SCT following Marqibo treatment. Three of the 5 patients had extramedullary leukemia including kidney involvement. One of the patients with a CR, who had failed multiple prior therapies including high-dose dexamethasone, presented with extensive kidney involvement with leukemia and kidney failure without bone marrow relapse. His CR was achieved in the context of a brief course of oral low-dose prednisone for appetite stimulation. Although technically a protocol violation, the low-dose prednisone is not believed to have had any influence on this patient's clinical response.
In accordance with the 2-stage trial design, at least 3 CR or CRp among the first 29 evaluable patients were required for the trial to advance to full enrollment. To date, the rALLy trial has dosed 25 patients, 5 of whom are not yet available for evaluation.
"We are thrilled by these early results in our rALLy trial, that we passed the go-no go threshold even before the half-way point in enrollment, and that Marqibo activity to date is consistent with data we have previously reported," stated Anne Hagey, M.D., Vice President and Chief Medical Officer. "We continue to believe that Marqibo has the potential to provide a therapeutic advantage for this very sick patient population for whom there are currently no approved or standard therapies. We look forward to completing full enrollment of this trial in the first half of next year."
"Hana's clinical trial in relapsed ALL is targeting a patient population where treatment options are extremely limited. Marqibo's clinical results from rALLy, as well as in previous ALL trials, suggest that it has the potential to provide a meaningful benefit to patients with this challenging disease," 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.
After Hana completes enrollment of the first 29 patients in the rALLy trial, the data will be submitted to the Independent Data Monitoring Committee (IDMC). The IDMC will examine the interim safety results of the trial and also focus on logistical issues such as accrual, retention, quality of clinical and laboratory data, and implications of results of external studies.
The primary objective of the rALLy study is to assess the efficacy and tolerability of single-agent, weekly Marqibo with dosing based on actual body surface area without dose capping. Secondary objectives include evaluation of safety, response duration, 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 SCT. Hana expects to enroll up to 56 evaluable patients in this clinical trial and is aiming for 9 or greater complete responses (i.e., CR, CRp, or CRi). Hana has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL. The rALLy trial is currently being conducted at thirty clinical sites in the U.S., Canada, Germany, Israel and the United Kingdom.
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 acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Vincristine is approved by the U.S. Food and Drug Administration as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine, a microtubule inhibitor, kills cancer cells when they enter a very specific point in the cell cycle, and its efficacy is concentration- and exposure duration-dependent. Marqibo extends the circulation time of vincristine in the bloodstream, increases targeting of the drug to malignant cells, and enhances exposure duration at the site of the disease. Unlike regular vincristine, Marqibo is dosed based on patient body surface area without the need to limit the dose to avoid neurotoxicities.
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 strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.
SOURCE: Hana Biosciences, Inc. |
