ARIAD and MolecularMD announce collaboration for a companion diagnostic test for the T315I BCR-ABL mutation in patients with CML

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ARIAD pharmaceuticals, Inc. (NASDAQ: ARIA) and MolecularMD Corporation today announced exclusive cooperation agreement in the MolecularMD developed a and marketed a companion diagnostic test the mutation of T315I du gène of the BCR-ABL in patients with chronic myeloid leukemia (CML) and Philadelphia-positive (Ph +) acute lymphoblastic leukemia (ALL) is identified.

ARIAD is its investigational, Pan-BCR-ABL inhibitor, Ponatinib, in the Central PACE study with patients with resistance or intolerance to CML and pH + ALL or the T315I mutation ahead. MolecularMD joined BCR-ABL mutation testing with its standardized and validated sequencing test in patients in ARIAD of early phase 1 study of Ponatinib and similar tests prior to treatment in the pace study leads.

Under the terms of this agreement, cooperation is MolecularMD his will further optimize existing sequencing test and a Premarket approval application (PMA) with the U.S. food and Drug Administration for the marketing of the diagnostic support. The companies expect MolecularMD to submitting the PMA at the same time, since ARIAD the new drug application (NDA) for Ponatinib in the year 2012 files. MolecularMD will seek also a CE marking for a companion diagnostic test kit in Europe. Once approved, will be responsible for the commercialization of diagnostic test T315I MolecularMD.

MolecularMD's expertise in the BCR-ABL mutation test is due, in part the ground-breaking research and intellectual property of scientific founder, Dr. Brian Druker, Director of the Oregon Health & Science University (OHSU) Knight Cancer Institute, Howard Hughes Medical Institute investigator and JELD-WEN Chair of leukemia research at OHSU. Dr. Druker was also a longtime scientific and medical staff by ARIAD in the development of Ponatinib.

"We believe that MolecularMD has more experience with T315I mutation assays as any other laboratory in the world," said Timothy p. Clackson, PhD., President of the research and development and Chief scientific officer of ARIAD. "We look forward, expand our highly productive cooperation with MolecularMD and look forward, together on the development of commercial test for the mutation of T315I."

"MolecularMD was founded with the aim of the clinically relevant molecular tests in the age targeted cancer therapies offer", commented Stéphane WONG, PhD., m.b.a., chief scientific officer of MolecularMD. "We work with ARIAD during the entire Ponatinib of the clinical development and parts of the excitement about the drug activity in resistant and intolerant CML patients and those with the T315I for the current therapies are null and void." "We look forward, our partnership with ARIAD promotion are, and we are looking forward to the commercialization of our T315I test as companion Diagnostics to Ponatinib."

Under conditions of the collaboration agreement, the T315I diagnostic test reimbursed ARIAD MolecularMD for predefined development expenditure. ARIAD pays also MolecularMD milestones for achieving the development and regulatory activities. Diagnostic MolecularMD Companion is developed to CML and pH + ALL patients to identify who the mutation T315I. A companion diagnostic test is not necessary that the broader uses of Ponatinib help patients, the resistance or intolerance to the current of the second generation of BCR-ABL inhibitor, when examined in the study of the pace. Many mutations in addition to T315I account for resistance to the currently marketed BCR-ABL inhibitor.

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ARIAD
MolecularMD Corporation