Oncolyze Announces FDA Orphan Drug Designation for OM-301 for the Treatment of Acute Myeloid Leukemia

NEW YORK, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Oncolyze, Inc, a biotech developing a disruptive technology for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for its pipeline compound OM-301 for the treatment of acute myeloid leukemia (AML). OM-301 is currently in pre-clinical development for AML and other cancers.

The FDA's Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. According to the American Cancer Society, there are approximately 20,000 new cases of AML each year. Orphan drug designation provides Oncolyze with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved. 

"We are actively fundraising to advance OM-301 into clinical trials. The orphan drug designation is an important milestone that further validates our efforts to investigate the value of OM-301 as a potentially groundbreaking therapy for patients with AML and other cancers," said Dr. Steven Evans, Co-Founder & CEO of Oncolyze. 


Oncolyze is developing a disruptive technology for the treatment of cancer. Our novel approach uses a simple mechanism of action to selectively kill cancer cells and cancer stem cells while sparing normal cells. This provides a highly effective treatment with potentially little to no side effects. Our lead drug candidate, OM-301, targets the cancer cell membrane and causes lysis/necrosis; many antibiotics kill bacteria in a similar way. Our initial therapeutic target is acute myeloid leukemia (AML). Most AML patients relapse within 1 year of standard therapy as it does not destroy cancer stem cells. As a result, AML has only a 25% five-year survival rate. In contrast, OM-301 has been shown to destroy leukemic cancer stem cells, which has the potential to disrupt current medical treatment. Following our proof of concept in AML, we expect to pursue development for patients with other hematologic and solid cancers.

For more information on Oncolyze, please visit the company's website at www.oncolyze.com, and follow us on LinkedIn


Mika Stojanovic

TNG Creative, LLC


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