MolecularMD Enters into Agreement with Breakthrough Therapeutics to Support Phase II Clinical Trial
Portland, Oregon August 15, 2006—MolecularMD, a molecular oncodiagnostics company, has recently entered into an agreement with Breakthrough Therapeutics, a private oncology company based in Greenwich, CT, to monitor residual disease levels in patients undergoing Phase II clinical trials of their lead peptide vaccine, ABLVAXTM (VAX100). ABLVAX is a therapeutic vaccine currently being evaluated as a treatment of patients with resistant chronic myeloid leukemia (CML). Under terms of the agreement, MolecularMD will perform molecular diagnostic test on all patients participating in the company’s ongoing Phase II trial. Specifically, MolecularMD will perform quantitative PCR (Polymerase Chain Reaction) measurements to detect patient levels of the BCR-ABL transcript, a well established biomarker for assessing disease remission in CML patients.
ABLVAX is currently being tested in CML patients who have a stable response to imatinib mesylate (Gleevec; Novartis) but have not become “molecular negative”. The multicenter trial plans to enroll a total of 60 patients of which all will be evaluated by MolecularMD.
MolecularMD retains accomplished experience and expertise in quantifying and analyzing genetic mutations related to hematological malignancies. Beyond the other methods to monitor disease remission such as white blood cell counts and cytogenetics, quantitative PCR offers the sensitivity and dynamic range required to accurately monitor a patient’s disease state over the period of a clinical trial. In addition to their vast experience in monitoring CML patients, MolecularMD incorporates unique sample preparation and measurement protocols that enhance the performance and reliability of the test.
Dr. Brian Druker, Scientific founder of Moelcular MD and Director of Oregon Health Sciences Center for Hematologic Malignancies noted, “We understand that the approach being studied by ABLVAX offers the greatest opportunity for long-term remission for patients with CML. The ability to reliably and consistently measure molecular evidence of CML will be a key factor to interpreting the benefit of ABLVAX and we are pleased that Breakthrough Pharmaceuticals has chosen MolecularMD for this task.”
“Because the endpoints for our clinical trial revolves around the ability to measure the effect of ABLVAX on minimal residual disease we felt it important to evaluate these responses in the best way possible. We are delighted to have MolecularMD as our “central lab” for this trial”, commented Rosemary Mazanet, MD, Ph.D., Chief Executive Officer of Breakthrough Therapeutics. “We are confident that their experience will be of great help in analyzing response patterns for our patients.”
About Chronic Myeloid Leukemia
Chronic myeloid leukemia (CML) is a form of leukemia caused by the abnormal growth of relatively mature white blood (myeloid) cells. CML affects 1 to 2 people in 100,000 and is responsible for 15% to 20% of all adult leukemia. CML is characterized by a specific chromosomal abnormality called the Philadelphia (Ph) chromosome. The Ph chromosome is the result of a translocation between two genes, which brings together the BCR (breakpoint cluster region) gene on chromosome 22 and the proto-oncogene ABL (Ableson leukemia virus) on chromosome 9. The resulting hybrid gene BCR-ABL activates signaling pathways that lead to uncontrolled cell growth.
About Breakthrough Therapeutics
Breakthrough Therapeutics is a privately owned biopharmaceutical company headquartered in Greenwich, Connecticut. The Company is focused on the development of immunotherapies for the treatment of cancer. The Company’s lead product, ABLVAXTM is currently in Phase II trials for the treatment of patients with chronic myeloid leukemia that have previously received therapy and have maintained stable disease.
About MolecularMD
MolecularMD is an oncodiagnostics company that specializes in developing, commercializing and performing state-of-the-art fusion gene and mutation assays. Our tests are used in both clinical and drug development settings to diagnose specific cancers and monitor the ongoing effectiveness of certain anticancer drugs. They are also used to predict patient responsiveness to targeted cancer therapies, such as the tyrosine kinase inhibitors. The scientific team, led by Dr. Brian Druker at the Oregon Health & Science University, has over 30 years of combined experience in CML research. Collectively, they have developed several sensitive and highly reliable molecular assays for leukemias, lymphomas, and solid tumor cancers. MolecularMD is a privately owned molecular diagnostics company based in Portland, Oregon.
