Vancouver, BC — Tekmira Pharmaceuticals Corporation (“Tekmira”; TSX:TKM) reported today that its development partner Hana Biosciences, Inc. (NASDAQ: HNAB) presented promising interim Phase 1 clinical data for cancer product candidate Alocrest™ (vinorelbine tartrate injection, OPTISOME™) at the "Molecular Targets and Cancer Therapeutics" International Conference in San Francisco, CA.
Hana Biosciences’ data demonstrated anti-tumor activity in three of eleven patients with refractory solid tumors and also showed that Alocrest was relatively well tolerated over multiple cycles of therapy.
Hana Biosciences said the early clinical data indicate that Alocrest, a drug consisting of the FDA-approved drug vinorelbine encapsulated inside the Optisomal drug delivery technology, may be extending circulation time and tolerability as compared to free vinorelbine. The company said the interim results illustrate the potential of Alocrest’s anti-cancer activity among patients with advanced, difficult-to-treat cancers.
Hana Biosciences will also make a presentation to the conference Thursday, October 25, 2007 of preclinical data that supports the company’s clinical plans for Alocrest and for product candidates Marqibo® (vincristine sulfate injection, OPTISOME™), and Brakiva™ (topotecan hydrochloride injection, OPTISOME™). The "Molecular Targets and Cancer Therapeutics" International Conference is sponsored by the American Association for Cancer Research, the National Cancer Institute, and the European Organization for Research and Treatment of Cancer.
Alocrest, Marqibo and Brakiva are chemotherapy product candidates that Tekmira licensed to Hana Biosciences in 2006. Under the Tekmira-Hana Biosciences agreement, Hana Biosciences is funding the development and commercialization of these product candidates and will pay milestone payments to Tekmira based on commercialization progress and royalties based on any future sales.
Timothy M. Ruane, President and CEO of Tekmira, said Hana’s promising interim data from the Phase 1 Alocrest trial is the latest of several clinical development successes in 2007 achieved by Hana with products licensed from Tekmira. “Hana is executing an aggressive clinical development program for our partnered product candidates,” said Ruane. “Their progress in 2007 has so far been impressive and we look forward to providing additional updates as Hana continues to advance these products through clinical development.”
Hana’s clinical development progress to date in 2007:
· In January 2007, Hana reported that Marqibo was granted Orphan Drug Designation by the United States Food and Drug Administration (FDA).
· In August 2007, Hana reported the initiation of a multi-center, multi-national Phase 2 clinical trial of Marqibo in adult patients with relapsed acute lymphoblastic leukemia (ALL), also known as the rALLy study.
· Hana also reported in August 2007 that Marqibo had received Fast Track designation from the FDA for the treatment of adult patients with Philadelphia chromosome negative ALL in second relapse or who have failed two lines of prior therapy.
Hana also plans to initiate four additional clinical trials for the Tekmira licensed products:
· A Phase 3 randomized, multicenter trial comparing Marqibo to vincristine in the induction, consolidation, and maintenance phases of treatment in elderly patients with ALL;
· A Phase 2 trial investigating Marqibo as a treatment for uveal melanoma; and
· A Phase 1 trial investigating Brakiva™ (topotecan hydrochloride injection, OPTISOME™) as a treatment for solid tumors.
Tekmira Pharmaceuticals Corporation is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about Tekmira and this news release can be found at www.tekmirapharm.com.
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James Hoggan & Associates Inc.
The common shares of Tekmira are traded on the Toronto Stock Exchange under the trading symbol “TKM”.