Skip to Content

Rhizen Pharmaceuticals S.A. receives FDA orphan-drug designation for Tenalisib (RP6530) for treatment of cutaneous T-cell lymphoma (CTCL)

La Chaux-de-Fonds, Switzerland, April 09, 2018 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the active moiety of Tenalisib (RP6530), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL).

“We are pleased to receive US FDA orphan-drug designations for the active moiety of Tenalisib (RP6530) for the treatment of peripheral and cutaneous T-cell Lymphoma (PTCL and CTCL), and we look forward to advancing the drug into further development for treatment of T-cell lymphoma,” said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A.

About FDA Orphan-Drug Designation

Orphan-Drug Designation is granted to a drug or biological product intended to treat a rare disease in the United States. A number of incentives are provided for an orphan-drug such as 7-year marketing exclusivity, tax credits for clinical development costs, exemption/waiver of application (filing) fees and assistance from the FDA Office of Orphan Products Development (OOPD) during the development process.

About Tenalisib (RP6530)

Tenalisib (RP6530) is a highly selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through enzyme, cell, and whole blood-based studies. Besides inhibiting growth of immortalized cancerous cell lines and primary patient leukemic/lymphoma cells, RP6530 plays a significant role in modulation of tumor microenvironment at clinically achievable concentrations. In preclinical studies, RP6530 reprograms macrophages from an immunosuppressive M2-like phenotype (pro-tumor) to an inflammatory M1-like state (anti-tumor), which can potentially enhance the activity of checkpoint inhibitors or overcome resistance to these drugs. Tenalisib obtained US FDA Fast Track Designation for treatment of peripheral T-cell lymphoma (PTCL) in addition to Orphan-Drug Designations for treatment of peripheral and cutaneous T-cell lymphoma (PTCL and CTCL).

About Rhizen Pharmaceuticals S.A.

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer, immune and metabolic disorders. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland. For additional information, please visit Rhizen’s website, www.rhizen.com.

Source: Rhizen Pharmaceuticals S.A.

Posted: April 2018

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.