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Oncolyze Announces FDA Orphan Drug Designation for OM-301 for the Treatment of Multiple Myeloma

Oncolyze Announces FDA Orphan Drug Designation for OM-301 for the Treatment of Multiple Myeloma

Oncolyze Logo

Oncolyze Logo

Oncolyze, which already holds an Orphan Drug Designation for its lead drug candidate OM-301 in treating acute myeloid leukemia (AML), is pleased to announce that the FDA has just granted OM-301 its second Orphan Drug Designation, for multiple myeloma. 

There are approximately 35,000 cases of multiple myeloma yearly in the U.S. The five-year survival rate for multiple myeloma is about 50%. Resistance to therapy is the primary challenge associated with relapse and recurrence of multiple myeloma, especially in elderly patients. The mainstays of treatment have been agents that affect the immune system, such as Revlimid® (BMS) used in combination with the generic corticosteroid dexamethasone. The prescribing of proteasome inhibitors such as Kyprolis® (Amgen / Ono) and Ninlaro® (Takeda), along with the emergence of novel drugs such as Darzalex® (Genmab / Janssen), is having an impact on treatment choices in the third-line setting.

Research has shown that OM-301 is effective against multiple myeloma. In vitro, OM-301 was effective against eight multiple myeloma cell lines including p53 mutated and null cell lines, and it prolonged survival in an in vivo proof of concept study.

Oncolyze has recently launched a Regulation A+ ("Reg A+") funding campaign to finance the company through the FDA pathway and to clinical trials; the company is spreading awareness of OM-301 among cancer patients, healthcare professionals, and the investment community. Regulation A+ is a type of offering that allows anyone to invest in Oncolyze and receive shares in the company. The investment opportunity is being hosted by StartEngine and investments may be made in Oncolyze directly by visiting the StartEngine website. Potential investors can also learn more about the investment opportunity at the Oncolyze website.


Oncolyze is developing a disruptive technology for the treatment of cancer. Our lead drug candidate, OM-301, has a simple mechanism of action to selectively kill cancer cells and cancer stem cells while sparing normal cells. This can provide a highly effective treatment with potentially little to no side effects. Our initial therapeutic target is AML. Most AML patients relapse within 1 year of treatment, as standard therapy is not very effective in destroying cancer stem cells. As a result, AML has only a 25% 5-year survival rate. In contrast, OM-301 has been shown to kill 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; multiple myeloma is a likely target for a following clinical trial.

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

You should read the Offering Circular and Risks related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC.  This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.  

This press release may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management's current views with respect to future events based on information currently available and are subject to risks and uncertainties that could cause the company's actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements as they are meant for illustrative purposes and they do not represent guarantees of future results, levels of activity, performance, or achievements, all of which cannot be made. Moreover, no person nor any other person or entity assumes responsibility for the accuracy and completeness of forward-looking statements, and is under no duty to update any such statements to conform them to actual results.

Contact Information:
Mika Stojanovic
Managing Partner, TNG Creative LLC
[email protected]

Original Source: Oncolyze Announces FDA Orphan Drug Designation for OM-301 for the Treatment of Multiple Myeloma