La Jolla Pharmaceutical Company announced that it has acquired global development and commercialization rights to GCS-100, a novel therapeutic, from privately held Solana Therapeutics, Inc. GCS-100 is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in cancer and chronic organ failure.
In connection with the acquisition, George F. Tidmarsh, M.D., Ph.D., the former Chief Executive Officer of Solana, was appointed as the Company's President and Chief Executive Officer. "Having been involved in the clinical development of GCS-100 over the past several years, I am thrilled to have the opportunity to continue this compound's development in the context of La Jolla," commented Dr. Tidmarsh. "Targeting galectin-3 holds great promise in the treatment of a broad range of life-threatening conditions, and, with GCS-100, we have the most advanced galectin-3-targeting compound in development."
Galectin-3 plays a key role in the immune system's response to cancer and tissue injury, making specific inhibitors of galectin-3 attractive therapeutic candidates for a wide range of life-threatening diseases, including cancer, heart failure, kidney disease, pulmonary fibrosis and liver fibrosis. For example, encouraging work conducted by investigators at the Ludwig Cancer Institute has shown that galectin-3 inhibits the activity of cancer-killing T-cells, and that pharmacologically blocking galectin-3 with GCS-100 reactivates these T-cells.
In addition, a number of independent, academic studies have concluded that galectin-3 is a mediator of fibrosis (scar formation) after heart, kidney, lung and liver injury. These include studies conducted by investigators at leading institutions such as Massachusetts General Hospital and The Cleveland Clinic demonstrating that elevated galectin-3 levels in blood following myocardial infarction (heart attack) represent a powerful predictor of adverse clinical outcomes for patients.
GCS-100's ongoing development as an anti-cancer and anti-fibrotic agent is supported by extensive preclinical and clinical investigation, including Phase 1 and Phase 2 clinical trials involving more than 140 patients.
Experimental results to date indicate that GCS-100:
-- Specifically inhibits galectin-3 in immune cells isolated from patients;
-- Confers anti-cancer activity in patients with several tumor types;
-- Exhibits effects on the immune system in patients consistent with its galectin-3 inhibitory mechanism; and
-- Is safe and well tolerated at doses that confer clinical activity.
Dr. Tidmarsh's 22 years of experience in biotechnology include the successful clinical development of three FDA-approved drugs. Up until his appointment to La Jolla, Dr. Tidmarsh served as the Chief Executive Officer of Solana Therapeutics, Inc. Previously, he served as the Chief Executive Officer of Horizon Pharma, Inc., a company he founded in 2005. While at Horizon, he led all aspects of development of Duexa, which was recently approved by the FDA for the treatment of rheumatoid arthritis. He also founded Threshold Pharmaceuticals, Inc. and held senior positions at Coulter Pharmaceutical, Inc. [acquired by GlaxoSmithKline] and SEQUUS Pharmaceuticals, Inc. [acquired by Johnson & Johnson] While at Coulter and SEQUUS, Dr. Tidmarsh led the clinical development of BEXXAR and Doxil, respectively, two FDA-approved anti-cancer agents. Dr. Tidmarsh received his M.D. and Ph.D. from Stanford University, where he also completed fellowship training in Pediatric Oncology and Neonatology and remains a Consulting Professor of Pediatrics and Neonatology.
In connection with this acquisition, Saiid Zarrabian was appointed as an independent director of the Company. Mr. Zarrabian has broad operational experience in the biotechnology and life sciences tools industries. He currently serves as President and Chief Executive Officer of Cyntellect, Inc., a life sciences instrumentation provider. Previously, Mr. Zarrabian was President and Chief Operating Officer of Senomyx, Inc., a biotechnology company that develops novel flavor ingredients. Prior to Senomyx, he was Chief Operating Officer of Pharmacopeia, Inc., a drug discovery company that was acquired by Ligand Pharmaceuticals, Inc., and President of Pharmacopeia's MSI division, a leading scientific enterprise R&D software provider that is now part of Accelrys, Inc. Mr. Zarrabian has served as a director of two biopharmaceutical companies: Ambit Biosciences Corporation and Penwest Pharmaceuticals Co. [acquired by Endo Pharmaceuticals].
Also in connection with the acquisition, the former members of the management team, Deirdre Y. Gillespie, M.D., President and Chief Executive Officer, and Gail A. Sloan, CPA, Chief Financial Officer, and the former members of the Board of Directors, Robert A. Fildes, Ph.D., Chairman, Bertrand C.
Liang, M.D., Ph.D., and Deirdre Y. Gillespie, M.D., have resigned.The holders of the Company's preferred stock entered into a consent and amendment agreement with the Company, whereby such holders approved the strategic transaction to acquire GCS-100, and certain terms of the preferred stock were amended. Additionally, the Company will effect a reverse split of its outstanding common stock, after which the conversion price for the Company's preferred stock may be subject to adjustment. More information regarding the preferred stock consent and amendment agreement, the reverse stock split, the acquisition of GCS-100, and changes to the Company's leadership are provided in a Current Report on Form 8-K that the Company will file with the Securities and Exchange Commission on January 20, 2012.