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Alocrest(tm) Phase 1 Data Demonstrates Potential for Improved Safety and Efficacy Compared to Conventional Vinorelbine. Menadione Topical Lotion Restores Kinase Activity and Does Not Inhibit the Anti-Tumor Effect of Erlotinib (Tarceva(r)) in Preclinical Models
SOUTH SAN FRANCISCO, CA, USA | July 7, 2008 | Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, presented data for two of the company's oncology product candidates, Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm)) and Menadione Topical Lotion, at the European Society for Medical Oncology Conference taking place July 3-6, 2008 in Lugano, Switzerland (ECLU). Alocrest is Hana's OPTISOME(tm) encapsulated formulation of vinorelbine tartrate intended for the treatment of certain solid tumor cancers and lymphomas. Menadione is a topical agent that Hana is currently evaluating in a Phase 1 clinical trial, for the treatment and/or prevention of Epidermal Growth Factor Receptor Inhibitor (EGFRI) associated skin toxicities.
Hana presented data from the company's Phase 1 clinical trial of Alocrest. A total of 30 subjects with advanced solid tumors or non-Hodgkin's lymphoma (NHL) were enrolled in the Phase 1 trial. The majority of the patients were classified as heavily pre-treated. Overall, this study achieved a disease control rate of 47 percent, including three of four elderly non-small cell lung cancer (NSCLC) subjects who achieved stable disease. Of 27 subjects with refractory solid tumors and 3 subjects with NHL evaluable for efficacy, one patient achieved a Partial Response (unconfirmed) and 13 patients achieved Stable Disease. A maximum tolerated dose (MTD) of 28 mg/m2 administered via a 60-minute IV infusion on days one and eight every 21 days was established in this population. While a separate MTD was not determined for non-heavily pre-treated subjects, Hana believes that the dose level could potentially be safely increased in patients who have received fewer rounds of prior treatment with other chemotherapy agents. Alocrest was generally well-tolerated with reversible neutropenia as the most common dose limiting toxicity. Optisomal encapsulation imparted no new toxicities and none of the patients experienced an injection site reaction. The Phase 1 study was conducted at the Cancer Therapy and Research Center and the START facility in San Antonio and McGill University in Montreal. These data were presented on Saturday, July 5, 2008 in poster #56P: "Phase 1 Study of the Sphingomyelin/Cholesterol Liposome Formulation of Vinorelbine in Subjects with Advanced Solid Tumors, Hodgkin's Disease, or Non-Hodgkin's Lymphoma."
"We are pleased to report Phase 1 data for Alocrest demonstrating prolonged stable disease and a solid tolerability profile at an MTD comparable to unencapsulated vinorelbine in heavily pre-treated patients," said Anne Hagey, M.D., Vice President and Chief Medical Officer of Hana Biosciences. "Based on these data, we continue to believe Alocrest has the potential to provide improved efficacy compared to conventional vinorelbine. Alocrest may be particularly beneficial to patient populations who cannot tolerate treatment with standard multi-agent chemotherapy regimens, such as elderly patients with NSCLC."
On Saturday, July 5, 2008, Roman Perez-Soler, M.D., Chief, Division of Oncology, Department of Medicine, Albert Einstein College of Medicine and Chair, Department of Oncology, Montefiore Medical Center, presented results of preclinical studies of menadione in poster #98P, entitled: "Local Rescue of Skin Toxicities Secondary to Kinase Inhibitor (KI) Therapy with Topical Menadione."
Researchers, led by Dr. Perez-Soler, conducted preclinical studies of menadione to better understand the potential interaction between topical menadione and systemically delivered erlotinib (Tarceva(r)), an approved EGFRI. Analysis from tests conducted in an in vivo model demonstrated that topical menadione did not affect the anti-tumor effect of erlotinib. In vitro studies were also conducted to investigate menadione's ability to restore kinase activity in the presence of specific kinase inhibitors. These data indicate that treatment with menadione may result in restoration of normal cell turnover rates and prevent skin toxicities that result from inhibition of protein kinases associated with tumor growth signaling pathways, such as the tyrosine kinases MEK, CDK and RAF.
"Results presented from preclinical studies of menadione topical lotion demonstrate that this compound does not interfere with the anti-cancer activity of Tarceva, an EGFRI, in a sensitive model. These data are encouraging and help provide the foundation of our strategy to develop this agent for the prevention and treatment of the skin toxicities associated with use of EGFRIs," said Dr. Hagey. "In addition, the initial data suggesting that menadione may also be useful in preventing and/or treating skin toxicities associated with the growing class of kinase inhibitors extends the exciting potential for this promising novel agent."
About Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm))
Alocrest is a novel sphingomyelin/cholesterol liposome-encapsulated vinorelbine tartrate formulation. Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule inhibitor that has been approved for use as a single agent or in combination with cisplatin for the first-line treatment of advanced non-small cell lung cancer. In several countries outside the United States, vinorelbine is also approved for the treatment of advanced stage breast cancer. Preclinical comparison data between commercially available vinorelbine tartrate injection (unencapsulated) and Alocrest demonstrated that Alocrest has improved pharmacokinetic properties, including an approximately 10-fold increase in preferential accumulation in tumors, and an improved therapeutic index.
About Menadione Topical Lotion
Menadione, a small organic molecule, has been shown in preclinical studies to activate the Epidermal Growth Factor Receptor (EGFR) signaling pathway by inhibiting phosphatase activity. EGFR inhibitors, or EGFRIs, are currently used to treat over 100,000 patients per year with a variety of cancers including non-small cell lung cancer, pancreatic, colorectal, and head & neck cancer. The majority of patients taking EGFRIs develop an associated skin rash. Loss of EGFR signaling has been hypothesized as a mechanism of skin toxicity in patients receiving EGFRIs. In vitro studies have suggested that topically-applied menadione may restore EGFR signaling at the dermal/epidermal junction, which could prove beneficial to patients receiving these agents as cancer therapy. Currently, there are no FDA-approved products or therapies available to treat these skin toxicities. Hana Biosciences in-licensed topical menadione from the Albert Einstein College of Medicine in New York in October 2006. A Phase 1 clinical trial is ongoing in the U.S. and Canada.
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 the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
SOURCE:Hana Biosciences, Inc. |
