GERMANTOWN, Md., Jan. 4 /PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc. , today announced the formation of its Clinical Advisory Board (CAB). The CAB will advise Avalon on all its clinical development programs. Currently, the company’s lead clinical candidate, AVN944 (IMPDH inhibitor), is in the late stages of a Phase I hematological malignancies clinical trial. Additional clinical programs are expected to ensue from the Beta catenin and Aurora pathways programs which are both in the lead optimization stage.
Brian J. Druker, M.D., a Howard Hughes Medical Institute Investigator, and JELD-WEN Chair of Leukemia Research and Professor of Medicine at the Oregon Health & Science University Cancer Institute will be Chair of the CAB. Dr. Druker is widely recognized for his seminal contributions to the discovery and development of Gleevec, one of the first molecularly targeted cancer drugs used in the treatment of chronic myelogenous leukemia (CML). He is also a member of the Avalon Scientific Advisory Board.
“We are excited about the formation of our Clinical Advisory Board because it further supports Avalon’s development and the clinical trial efforts in progress,” said Kenneth Carter, Ph.D., President and CEO of Avalon. “I am especially pleased to expand Avalon’s association with Brian Druker in his added role as Chair of our Clinical Advisory Board. Inosine Monophosphate Dehydrogenase (IMPDH), the target of AVN944, is an important emerging target in the treatment of hematological and other cancers and the counsel from the Clinical Advisory Board will be important as we move into later stage clinical development. Further, we also look forward to their counsel on the use of our novel molecular profiling biomarkers strategies during clinical trials using our core technology AvalonRx.”
The CAB further consists of a number of clinical thought leaders from around the country. “We are honored to have such a distinguished group of clinicians join the Clinical Advisory Board,” said Michael Hamilton, M.D., Chief Medical Officer at Avalon. “We believe that the experience and expertise as reflected in the membership will benefit Avalon and guide the direction of all our clinical programs.”
Other members of the Clinical Advisory Board include the following:
Beverly Mitchell, M.D., Deputy Director of the Stanford University Comprehensive Cancer Center. Dr. Mitchell’s research relates to the development of new therapies for hematologic malignancies. She has a longstanding interest in IMPDH as a therapeutic target and has published extensively on the regulation of this enzyme and the potential role of inhibitors in the treatment of leukemia in preclinical and clinical investigations.
Carmen Allegra, M.D., Co-Director of the Foundation Research Program for the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Medical Director for the Network for Medical Communication and Research. Dr. Allegra is a board certified medical oncologist with expertise in the study and treatment of colorectal cancer. His FRP responsibilities include the development and oversight of clinical trials in colorectal cancer. Prior to joining the FRP, Dr. Allegra developed an international reputation through his extensive contributions to the medical literature during his 20 years as an investigator and Medicine Branch Chief at the National Cancer Institute.
Kenneth C. Anderson, M.D., Chief of the Division of Hematologic Neoplasia, Director of the Jerome Lipper Multiple Myeloma Center, and Vice Chair of the Joint Program in Transfusion Medicine at Dana-Farber Cancer Institute. Dr. Anderson has been a leader in the discovery of pathways that regulate growth of multiple myeloma cells and in the testing in clinical trials of drugs that disrupt these pathways.
Otis Brawley, M.D., Professor of Hematology, Oncology and Medicine at the Emory University School of Medicine and Professor of Epidemiology at the Emory Rollins School of Public Health. He also serves as Associate Director of the Winship Cancer Institute at Emory University. In addition, Dr. Brawley is Chief of Hematology and Oncology Services and the Medical Director of the Georgia Cancer Coalition Center of Excellence at Gardy Memorial Hospital.
Edward A. Sausville, M.D., Ph.D., Professor of Medicine and Associate Director for Clinical Research at the University of Maryland Marlene and Stewart Greenebaum Cancer Center. In collaboration with Millennium Pharmaceuticals, Dr. Sausville was instrumental in bringing to clinical study the drug Velcade, the first of a new class of medicines called proteasome inhibitors.
Chris H. Takimoto, M.D., Ph.D., Director of Pharmacology and holds the Zachry Chair of Translational Research at the Institute for Drug Development. Doctor Takimoto is an expert in Phase I and early clinical development of cancer therapies.
These cancer authorities provide a cross-section of expertise in hematologic and solid malignancies, clinical trials design, and pharmaceutical development.
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine monophospate 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 AvalonRx(R)
AvalonRx(R) is a comprehensive, innovative and proprietary suite of technologies based upon large-scale gene expression analysis. This platform facilitates drug discovery by expanding the range of therapeutic targets for drug intervention, including targets and target pathways frequently considered intractable using conventional HTS approaches, allows more informed decisions about which compounds to advance towards clinical trials, and facilitates drug development through identification of biomarkers of efficacy that can stratify patients or provide early indicators of response.
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), preclinical programs to discover inhibitors for the Beta-catenin and Aurora pathways and drug discovery collaborations with MedImmune, Novartis, ChemDiv and Medarex. Avalon Pharmaceuticals was established in 1999 and is headquartered in Germantown, Md.
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 2005 Annual Report on Form 10-K and updates contained in subsequent filings we make with the SEC.
Contacts: Avalon Pharmaceuticals, Inc. Noonan Russo Gary Lessing Wendy Lau (Media) Executive Vice President & CFO Tel: (212) 845-4272 Tel: (301) 556-9900 Fax: (301) 556-9910 The Trout Group LLC Email: info@avalonrx.com Chad Rubin (Investors) Tel: (212) 477-9007 ext. 47
Avalon Pharmaceuticals, Inc.
CONTACT: Gary Lessing, Executive Vice President & CFO, AvalonPharmaceuticals, Inc., +1-301-556-9900, Fax: +1-301-556-9910,info@avalonrx.com; Media - Wendy Lau, of Noonan Russo, +1-212-845-4272;Investors - Chad Rubin, of The Trout Group LLC, +1-212-477-9007 ext. 47
