GERMANTOWN, Md., July 12 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. , today announced the initiation of a Phase II clinical trial in pancreatic cancer patients. The protocol has been activated and is now open for enrollment as patients are being evaluated to start study treatment. The first active center is Yale University -- Yale Cancer Center. The Company expects to enroll patients at approximately fifteen sites for the trial.
“The advancement of AVN944 into a Phase II trial in solid tumors represents a significant milestone for AVN944 and Avalon Pharmaceuticals,” said Kenneth C. Carter, Ph.D., President and CEO. “We believe AVN944 has the potential to provide patient benefit in several cancer types.”
The trial will be conducted in two parts (Part A and Part B), both using an open-label, non-controlled design. Eligible patients will include adult patients with advanced newly diagnosed pancreatic cancer. Part A is a dose- escalation study with a primary objective to determine the maximum tolerated dose or effective biologic dose of AVN944 in combination with gemcitabine. Approximately 15-20 patients will be enrolled in Part A. Part B is to establish the efficacy and safety of the AVN944/gemcitabine combination and approximately 110-120 patients will be enrolled. Patients will receive an initial treatment cycle of AVN944 and gemcitabine and may receive additional cycles of treatment every 28 days at the discretion of the Investigator and with the agreement of the patient. Information on the trial is available at the National Institutes of Health clinical trial database and will be updated when additional sites initiate treatment, www.ClinicalTrials.gov (a service of the U.S. National Institutes of Health developed by the National Library of Medicine).
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monosphospate dehydrogenase (IMPDH), an enzyme that is critical for cells to be able to synthesize guanosine triphosphate (GTP), a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in some cancer cells, especially in the case of hematological malignancies. In laboratory experiments, AVN944 has been shown to inhibit IMPDH activity in cells, and suppress pools of GTP. Anticancer activities of IMPDH inhibitors correlate with sustained depletion of GTP pools both in cellular models and in human subjects. AVN944 appears to have a selective effect on cancer cells in that deprivation of GTP in normal cells results in a temporary slowing of cell growth, while GTP deprivation in cancer cells induces cell death, or apoptosis.
Results from preclinical studies of AVN944 indicate that AVN944 inhibited the proliferation of lymphoid and myeloid cells, the principal cells involved in the most common types of human leukemias. In a single-dose, dose- escalation Phase I clinical trial of AVN944 conducted in the United Kingdom in healthy volunteers, AVN944: (1) was well tolerated at all tested doses with no notable side effects; (2) demonstrated good pharmacokinetic properties; and (3) had a significant inhibitory effect on IMPDH enzyme activity. Avalon filed an IND with the FDA in August 2005 and initiated U.S. phase I clinical trials in January 2006 for the treatment of hematological cancers.
About Gemcitabine HCI (GEMZAR(TM))
Gemcitabine is a chemotherapy drug that is used to treat certain types of cancer (non-small cell lung cancer, metastatic breast cancer, ovarian cancer, and pancreatic cancer). Chemotherapy drugs act to control the growth of rapidly dividing cells, including cancer cells. (Cancer cells are abnormal cells which are growing at an uncontrolled rate.) The goal of chemotherapy is to kill as many cancer cells as possible or to stop them from dividing and making more cancer cells. Gemcitabine works by interfering with the process by which cells divide and repair themselves, thus preventing the further growth of cancer cells and leading to cell death.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its proprietary technology, AvalonRx(R), to discover and develop cancer therapeutics. Avalon has a lead product in Phase I clinical development (AVN944 -- IMPDH inhibitor), as well as preclinical programs to discover inhibitors for the beta-catenin and aurora pathways now in late stage lead candidate optimization. Avalon also has discovery programs on modulators of survivin function and a drug discovery program targeting the MYC oncoprotein, one of the most important and previously intractable cancer targets. The Company has value generating partnerships with Merck, MedImmune, Medarex, and Novartis. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Maryland.
Safe Harbor Statement
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to progress in our drug discovery programs and our collaborations, and clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that the discovery programs and collaborations may not be successful and that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that our development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success. The information in this Release should be read in conjunction with the Risk Factors set forth in our 2006 Annual Report, on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts: Avalon Pharmaceuticals, Inc. Russo Partners, LLC David D. Muth Wendy Lau (Media) Executive Vice President & Tel: (212) 845-4272 Chief Business Officer Tel: (301) 556-9900 Fax: (301) 556-9910 The Trout Group LLC Email: info@avalonrx.com Chad Rubin (Investors) Tel: (646) 378-2947
Avalon Pharmaceuticals, Inc.
CONTACT: David D. Muth, Executive Vice President & Chief Business Officer,Avalon Pharmaceuticals, Inc., +1-301-556-9900, Fax, +1-301-556-9910,info@avalonrx.com; or Media, Wendy Lau of Russo Partners, LLC,+1-212-845-4272; or Investors, Chad Rubin of The Trout Group LLC,+1-646-378-2947, both for Avalon Pharmaceuticals, Inc.
