La Jolla, CA (January 31, 2019) – DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic cancer clinical trial. In addition, the lead program received orphan-drug designation from the US Food and Drug administration (FDA) in pancreatic cancer. The company also announced a new member of board of directors.
The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30 patients in the second quarter of 2019. The early results are reportedly encouraging, with high response rates as well as favorable safety profile, with no dose-limiting toxicities. “The progress with the pancreatic cancer trial has exceeded our expectations” said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. “Our near term goal is to validate the CEND-1 platform technology in multiple indications so clinicians can treat patients with cancers with high unmet medical need more effectively.”
Receiving the FDA orphan drug designation was also announced today. It is a significant development milestone as it can facilitate the future development through several benefits such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.
Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its Board of Directors. “I am pleased to welcome Heidi Henson to our board, where her extensive expertise in financial management and strategy will be a major asset to DrugCendR as we continue to advance the company programs.” said Erkki Ruoslahti, M.D., Ph.D., Founder, President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.