Cyclacel Pharma (CYCC) Stock Skyrockets 50% On Positive Phase 1 Data

On Monday, shares of Cyclacel Pharmaceuticals (NASDAQ:CYCC) are skyrocketing, up over 50% after the company reported positive Phase 1 data for one of its lead drug candidates.

The trial revolves around Seliciclib, a combination treatment that combines two of the company’s drugs: seliciclib and sapacitabine. Seliciclib is a cyclin dependent kinase inhibitor while sapacitabine is a nucleoside analogue.

The study treated 45 patients with breast, ovarian, and pancreatic cancers who each tested positive for BRCA mutations, and the results showed significant improvements and strong responses to the treatment. More data will soon be offered during a presentation at the 2016 American Society of Clinical Oncology annual meeting.

Several key figures close to the study commented:

“Our findings from Parts 1 and 2 of the study have shown that the orally-administered regimen is well tolerated with manageable toxicities. Based on the results, we believe that further clinical evaluation of this combination regimen is warranted. A Part 3 extension of the study is currently enrolling advanced breast cancer patients with BRCA mutations,” said Sara M. Tolaney, M.D., M.P.H., Associate Director of Clinical Research and Breast Oncology at the Dana-Farber Cancer Institute in Boston.

“This clinical observation may be directly related to the drug's interference with the capacity of BRCA-mutated cancer cells to repair and survive sapacitabine-included breaks in their DNA. If these preliminary findings are confirmed by further data, this regimen may provide an important treatment options for patients with BRCA-mutated cancers,” said Judy Chiao, M.D., Vice President of Clinical Development and Regulatory Affairs at CYCC.

“We are encouraged with the durability of responses and stable disease, with ongoing responding patients achieving treatment durations exceeding 1 and 4.5 years, respectively. We look forward to reporting data from the ongoing Part 3 extension in BRCA positive patients with breast cancer and increasing our understanding of the potential benefit of this differentiated treatment strategy in a targeted patient population with significant unmet medical need,” said Spiro Rombotis, President and CEO at CYCC.

Cyclacel Pharma is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders.