Molecular Biometrics has announced the completion of a licensing agreement with McGill University, Montreal, Canada, that secures a broad patent portfolio for the company's metabolomics technology platform.
The Company also announced that it is expediting the development of its lead indication of embryo selection for in-vitro fertilization (IVF) and plans to enter into a pivotal U.S. clinical trial early in 2007.
Under the licensing agreement with McGill University, Molecular Biometrics has licensed five broad patents relating to metabolomics and biospectroscopy of biomarkers for use in all biomedical applications, including molecular diagnostics, drug discovery and development and personalized medicine.
The Company's technology platform has application in numerous therapeutic categories.
To date, Molecular Biometrics has validated its technology in IVF and in four additional therapeutic classes including, but not limited to, maternal fetal medicine, neurodegenerative diseases, lactate metabolism and pulmonary metabolism.
Molecular Biometrics is presently focused on pursuing its lead indication in IVF and is engaged in discussions with biotechnology and pharmaceutical firms to develop additional indications through partnership agreements.
James T. Posillico, Ph.D., Chief Executive Officer of Molecular Biometrics, commented, "The licensing agreement with McGill affords Molecular Biometrics five key patents and a secure and broad intellectual property position that ensures the company's freedom to operate and leadership position in metabolomic profiling in numerous therapeutic areas."
Dr. Posillico continued, "Our metabolomic technology platform will initially be applied in the development of molecular diagnostics that can rapidly identify, predict and monitor disease, as well as in pharmacodiagnostics for drug discovery and development. Our lead product candidate, ViaTest-E, is a rapid, non-invasive method to accurately select viable embryos in IVF."
The Company has tested ViaTest-E™ in 432 samples and has commenced a multi-national, multi-center clinical study in 16 IVF programs in the USA, Europe and Japan. Molecular Biometrics is employing a focused regulatory strategy to achieve marketing approval for ViaTest-E™.
According to company, IVF currently requires three or more treatment cycles to achieve a live birth because only 15 percent of embryos transferred in IVF result in pregnancies.
To overcome these limitations, IVF programs have adopted the clinical practice of multiple embryo transfer (MET) to achieve current pregnancy rates.This in turn, has led to an increased incidence of multiple births with associated neo-natal healthcare costs exceeding $650 million annually.