Commercial rights to intellectual property

MolecularMD has entered an agreement for exclusive rights to patented intellectual property related to the detection of Imatinib resistant BCR-ABL mutations

MolecularMD, a developer and provider of cancer-based molecular diagnostics, has entered into a license agreement with the Oregon Health and Science University to obtain exclusive commercial rights to patented intellectual property (USPTO Patent # 7326534) related to the detection of Gleevec (imatinib) resistant BCR-ABL mutations.

Gleevec, a targeted tyrosine kinase inhibitor drug, has proven to be a highly effective front line therapy for the treatment of chronic mylogenous leukemia (CML).

The drug blocks the unregulated enzyme activity of the fusion tyrosine kinase protein BCR-ABL.

BCR-ABL stems from a chromosomal translocation forming the Philadelphia chromosome present in malignant bone marrow cells of CML patients.

While most CML patients exhibit excellent primary response to imatinib, a proportion of patients develop acquired secondary resistance via point mutations in the ABL kinase domain.

These mutations can interfere with the binding of imatinib to the BCR-ABL protein and lead to disease progression.

The T315I mutation is of particular interest to drug development companies as it has manifested complete resistance to all current kinase inhibitors drugs indicated for CML.

Tasigna (nilotinib, Novartis) and Sprycel (dasatinib, Bristol-Myers Squibb) were recently approved as second line treatments for CML patients that are intolerant or resistant to imatinib.

MolecularMD is the leader in developing and providing molecular diagnostic tests for CML patient monitoring and measuring patient response of new compounds in clinical trials.

Through this exclusive license, MolecularMD plans to develop and commercialize novel approaches to detecting and quantifying BCR-ABL mutations.

These efforts will be aimed at providing better performance, convenience and reliability for patients, doctors, and drug developers.

MolecularMD currently provides diagnostic services for BCR-ABL mutation analysis and a highly sensitive assay for T315I detection.

The investigation and initial discovery of the imatinib resistant mutations was led by Brian Druker and Amie Corbin from the OHSU.

Their research is the subject of a recently approved patent that claims intellectual property covering all methods and applications for the detection of Gleevec resistant mutations.

"Greater understanding of the mechanisms of Gleevec resistance in CML has already led to greater treatment options for those patients who develop resistant BCR-ABL point mutations," said Brian Druker, director of the OHSU Cancer Institute and Scientific Founder of MolecularMD.

"MolecularMD is well positioned to further develop methods for the detection of Gleevec resistant mutations and to support clinical, pharmaceutical, and diagnostic organisations dedicated to improving CML patient outcomes.".

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