Rueil-Malmaison, France, April 17, 2015 --(PR.com
)-- Karcinolys SAS (www.karcinolys.com
), a privately-held biotechnology company, today announced the formation of Pancrealys (www.pancrealys.com
), a new division within the company that has been designed to accelerate the development of its Myb34.5 oncolytic virus in pancreatic cancer. Ultimately, Pancrealys will be spun-out as a stand-alone company, allowing new investors to join.
Following the recent publication of preclinical results by its academic collaborators, and two orphan designations (in the US and in Europe) in pancreatic cancer, the company decided to form a dedicated vehicle whose mission is to concentrate skills and resources to rapidly bring this promising drug candidate to pancreatic cancer patients.
Pancrealys will be led by Jean-Luc Béjot, MD, MBA, and Karcinolys’ CEO. He will be joined by Amina Zinai, MD, PharmD, as Clinical Development Advisor, and Christian Girard, MIM, as Corporate Advisor, in charge of non-dilutive funding (directed to cancer patients associations and foundations), and a planned equity crowdfunding campaign. Visit the Team page at www.pancrealys.com to view Amina Zinai’s and Christian Girard’s profiles.
Karcinolys also announced the formation of a Pancreatic Cancer Scientific Advisory Board, whose members include Pr. Louis Buscail, MD, PhD, Pierre Cordelier, PhD, Alberto Epstein, PhD, and Pr. Ruth Plummer, MD. Visit the Scientific Advisory Board page at www.pancrealys.com for more information.
“I am delighted to see these talented professionals having accepted to join us in this project,” said Jean-Luc Béjot, the company’s founder and CEO. “We have now a great team aboard, which will allow us to complete the preclinical development of our lead drug candidate in a disease with great unmet medical need, and start clinical trials, presumably at the end of next year,” he added.
Myb34.5 is a replication-conditional oncolytic virus derived from herpes simplex virus type 1 (HSV-1) through targeted genetic engineering. The key mutation is the insertion of cellular transcription factor b-myb gene as a promoter gene sequence controlling and retargeting the expression of HSV-1 virulence gene gamma34.5 (γ34.5). Replication of Myb34.5 in infected cells is conditioned by the expression of b-myb, which has been found to be over-expressed in pancreatic ductal adenocarcinoma cells. Myb34.5 selectively replicates in cancer cells, resulting in infected cancer cell death, while sparing normal surrounding tissue cells. Karcinolys in-licensed Myb34.5 from Massachusetts General Hospital (MGH, Harvard University, Boston, Ma., USA) in 2007.
Myb34.5 was granted orphan drug designation by the FDA on December 23, 2014, and by the European Commission on January, 15th 2015. Myb34.5 is not approved for sale for any indication.
About Pancreatic Cancer
Pancreatic cancer develops in the exocrine glandular system of the pancreas. Since more than 90% of pancreatic cancers originate from the ductal epithelium, the term pancreatic cancer is commonly used in the literature as a synonym to pancreatic ductal adenocarcinoma.
The aetiology of pancreatic cancer remains largely unknown. Evidence of a causative role has been identified only for smoking tobacco, with a risk 2.5 to 3.6 times higher than in non-smokers.
The 2012 estimated incidences of pancreatic cancer were approximately 80,000 in the Europe Community and 43,000 in the United States of America. The incidence is slowly increasing.
In only 10-20% of patients with pancreatic cancer, the tumour is surgically resectable at the time of diagnosis. Eighty to 90% of pancreatic cancers are diagnosed at a stage at which the tumour is unresectable. At this stage, the standard treatments mostly rely on only a few approved palliative chemotherapies and targeted therapies.
Karcinolys is a biotechnology company focused on developing oncolytic virus Myb34.5 in oncology indications. Myb34.5 is currently in preclinical studies for pancreatic cancer and hepatocellular carcinoma. The company expects that first-in-man trials in pancreatic cancer could start at the end of H2 2016.
For more information, please visit the Company’s website at www.karcinolys.com and Pancrealys website at www.pancrealys.com