Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

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


Posted on: 22 Dec 17

La Chaux-de-Fonds, Switzerland, Dec. 22, 2017 (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 peripheral T-cell lymphoma (PTCL).

“We are pleased to receive US FDA orphan-drug designation for the active moiety of Tenalisib (RP6530), our Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, and we look forward to advancing the drug into further development for treatment of peripheral T-cell lymphoma (PTCL),” 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 and Orphan-Drug Designations for treatment of peripheral T-cell lymphoma (PTCL).  

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.

CONTACT: Contact: Kumar V. Penmetsa, Ph.D. Executive Vice President, Corporate Development Rhizen Pharmaceuticals S.A. Telephone: +1-267-207-5707 Email: kvp@rhizen.comGlobeNewswire
globenewswire.com

Last updated on: 26/12/2017

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.