Life and Death

PORTLAND, Ore.--(BUSINESS WIRE)--Aug. 30, 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, ABLVAX(TM) (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 tests 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 MolecularMD 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 revolve 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 MolecularMD

MolecularMD, a privately owned molecular diagnostics company, 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. 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.