VARIAGENICS Announces Key Initiatives in Chemotherapy Metabolism
Efforts Focus on Cytochrome P4503A Family to Predict Response to Cancer Drugs
CAMBRIDGE, Mass.--(BW HealthWire)--July 25, 2002--VARIAGENICS, INC. (Nasdaq: VGNX - News), an emerging molecular diagnostics company and a leader in pharmacogenomics, today announced that it has completed a license agreement with St. Jude Children's Research Hospital in Memphis. The Company also announced the completion of the patient enrollment phase of a related pharmacogenomic research study. Both efforts involve cytochrome P4503A (CYP3A), a family of drug-metabolizing genes that plays a role in more than 50 percent of all cancer agents, therefore, directly affecting the safety and efficacy of these drugs in patients.
The St. Jude license agreement covers a patent application claiming CYP3A5 genotyping methods and diagnostic test kits predictive of variable expression of CYP3A5, a member of the CYP3A family that has been associated with the metabolism of a wide range of cancer therapeutics, including irinotecan (Camptosar®, Pharmacia Corporation). Under the terms of the agreement, VARIAGENICS has obtained exclusive rights in the field of oncology to develop diagnostic test products predictive of drug response.
VARIAGENICS is also conducting a prospective, Phase I clinical study of a therapeutic proxy, midazolam, to identify the genetic contribution to variation in drug metabolism in members of the CYP3A family. As are many anti-cancer chemotherapies, midazolam is a substrate for the CYP3A family. VARIAGENICS' pharmacogenomic analysis of the samples within this study may determine the individual contributions of metabolizing enzymes CYP3A4, CYP3A5, CYP3A7, and CYP3A43 to drug metabolism and efficacy in patients undergoing chemotherapeutic treatments. Results from this study are expected in the first quarter of 2003.
"These critical initiatives allow VARIAGENICS to strengthen its molecular diagnostics program in oncology by securing access to and validating key genetic markers that may help predict the safety and efficacy of a broad spectrum of cancer therapeutics," commented Jay Mohr, VARIAGENICS' President and Chief Business Officer. "In particular, the St. Jude license will enable VARIAGENICS to develop assays for specific genetic variations (polymorphisms) associated with differential cytochrome expression in oncology patients that may lead to the creation of diagnostic tests predictive of drug response."
Mr. Mohr stated further that, "P450s have become standard pharmacogenomic markers in the pharmaceutical industry for predicting the toxic effects of drugs. Through this trial and the St. Jude license, we plan to develop CYP3A molecular diagnostics, which we expect will become a standard component for making treatment decisions in cancer. Many cancer patients are prescribed at least one cytotoxic agent, which gives an indication of the medical need for and the commercial potential of diagnostic markers in this market. It is also very encouraging to know that the FDA is already evaluating at least 15 regulatory submissions in which pharmacogenomic tests were included to analyze the variability of the CYP enzymes(1)."
ABOUT ST. JUDE CHILDREN'S RESEARCH HOSPITAL
St. Jude Children's Research Hospital, in Memphis, Tennessee, was founded by the late entertainer Danny Thomas. The hospital is an internationally recognized biomedical research center dedicated to finding cures for catastrophic diseases of childhood. The hospital's work is supported through funds raised by ALSAC. ALSAC covers all costs not covered by insurance for medical treatment rendered at St. Jude Children's Research Hospital. Families without insurance are never asked to pay. For more information, please visit www.stjude.org.
ABOUT VARIAGENICS, INC.
VARIAGENICS, INC. applies its pharmacogenomic technologies to the discovery, development and commercialization of personalized drugs and companion molecular diagnostic products focused primarily in the cancer area. The Company identifies therapeutically important genetic markers, including SNPs, haplotypes and, for cancer studies, loss-of-heterozygosity (LOH) and other related indicators. This information is then applied to clinical programs to enhance the success rates of drugs in development, and ultimately to the creation of diagnostics for predicting patient overall response to drugs. |
