La Chaux-de-Fonds, Switzerland, Sept. 22, 2015 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A. has announced the initiation of Phase 2 study of RV1001, a novel, oral selective inhibitor of PI3K delta, for the treatment of lymphoma in dogs.
--- RV1001 granted “minor use” designation on July 29, 2015 in accordance with the Minor Use Minor Species (MUMS) Act. Under section 573(c)(1) of the Federal Food, Drug, and Cosmetic Act, this designation qualifies RV1001 for SEVEN years of exclusive marketing rights relative to the intended use stated above beginning on the date of approval or conditional approval of this product for this intended use.
A Phase 1 dose escalation study of RV1001 was completed with the drug showing remarkable single agent activity in T- and B-cell Non-Hodgkin’s Lymphoma (NHL) with acceptable safety. Of the 21 dogs treated, 3 dogs had a complete response to therapy (CR) and 11 dogs had a partial response to therapy (PR) with an overall objective response rate of 67%. “RV1001 Phase 1 results were highly promising warranting further development of this novel, orally bioavailable treatment for dogs with lymphoma,” commented Dr. Cheryl London, D.V.M., Ph.D., Diplomate of the ACVIM (Oncology), Shackelford Professor of Veterinary Medicine at the Ohio State University College of Veterinary Medicine and Lead Principal Investigator of RV1001 development.
Dr. Cheryl London serves as the Principal Investigator for the ongoing Phase 2 study, which is being conducted at several sites within United States of America.
About RV1001:
RV1001 is a novel, oral selective inhibitor of PI3K delta, currently in Phase 2 development for the treatment of lymphoma in dogs.
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 in humans and dogs. Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland. For additional information, please visit Rhizen’s website, www.rhizen.com.