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DrugCendR Inc., a biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, announced today the treatment of the first patient in a Phase 1 clinical trial evaluating its lead compound CEND-1 (scientifically known as iRGD), in patients with metastatic pancreatic adenocarcinoma (CEND1-001, Clinical trial reference NCT03517176).
“Treating the first patient is an exciting milestone for our technology platform and for the company.” said Erkki Ruoslahti, President and CEO of DrugCendR Inc. “We chose to conduct the first study in pancreatic cancer, a cancer that is in desperate need of more effective therapies and shown to respond to CEND-1. Studies in preclinical models conducted all over the world also show that CEND-1 has wider potential; it enhances the therapy of many types of cancers by many types of drugs. We hope to make that potential a reality in the treatment of human cancer.”
Chief Operating Officer, Harri Jarvelainen continues, “We initiated our IND-enabling program a year ago so it is a great achievement to start dosing in this multi-site trial already now. Data from more than 100 publications have consistently demonstrated that CEND-1 is effective in the treatment of various types of solid tumors – but importantly, it is also a safe and well-tolerated compound, thanks to its tumor specific mechanism of action. As the extent of preclinical validation is almost unprecedented, we have a high confidence in the clinical translation of our therapy and hope that it will be soon available to patients with this and other cancers with high unmet medical need.”
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RECENT NEWS & RESOURCES
(Kyoto, Japan / La Jolla, CA) – INNOVATION Kyoto 2016 Limited Liability Partnership (“KYOTO-iCAP 1st Fund”), and Kyoto University Innovation Capital Co., Ltd. (the general partner. Headquarters: Sakyo-ku, Kyoto City; CEO: Koji Murota; “Kyoto-iCAP”) and DrugCendR Inc. (Headquarters: La Jolla, CA, US; President and CEO: Erkki Ruoslahti; “DrugCendR”) today jointly announced that it has concluded a multimillion-dollar investment in DrugCendR, to accelerate the global development of DrugCendR’s breakthrough tumor penetrating technology.
“I am delighted to announce the completion of the strategic investment in DrugCendR Inc. We, Kyoto-iCAP, will continue to support the development of DrugCendR’s technologies in the long term.”said Koji Murota, CEO of Kyoto-iCAP.
“This investment into DrugCendR Inc. by Kyoto-iCAP and Kyoto University will allow us to complete our ongoing phase 1 clinical trial on the lead compound of the company” stated Dr. Erkki Ruoslahti, M.D., Ph.D., President and CEO of DrugCendR. “The strategic relationship with the fund and Kyoto University, a preeminent university in the world, will be important for us into the future. We will also collaborate with clinical researchers led by Dr. Yoshiharu Sakai, M.D., Ph.D., Professor of Surgery on clinical studies the university is uniquely equipped to perform. We hope to provide new treatment options for cancer patients in the US, Japan and elsewhere in the world.”
Concurrent with the investment, DrugCendR will initiate non-clinical and clinical research collaboration with Kyoto University. Professor Yoshiharu Sakai, M.D., Ph.D., Gastrointestinal Surgery, Department of Surgery, Kyoto University and Associate Professor Kazutaka Obama, M.D., Ph.D. will lead the collaboration for Kyoto University.
DrugCendR Inc. COO Harri Jarvelainen will present a poster at the annual American Association for Cancer Research (AACR) meeting (March 29-April 4, 2019, Atlanta, GA). The poster is entitled “Co-administration of the iRGD tumor-penetrating peptide improves the tumor immunostimulatory effects of low-dose IL-2”.
More details here: http://biocomglobalpartnering.org/.
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.
Harri Jarvelainen, COO of DrugCendR Inc., will meet investors and present data during the 37th JP Morgan Healthcare Conference, Jan 7-10, 2018, in San Francisco. Contact us for more information.
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