“Life is short, and the process is long.” That’s what Cleveland BioLabs (NASDAQ:CBLI) President Dr. Michael Fonstein told Forbes last year while discussing the U.S. Food and Drug Administration’s regulatory process. Cleveland BioLabs shifted the development of several of their drugs from the U.S. to Russia, the birthplace of the company and a land where regulations are more flexible, in order to expedite the process towards commercialization.
In 2011, Cleveland BioLabs and Rusnano, a company and fund owned by the Russian government, partnered to start Panacela Labs in collaboration with Roswell Park Cancer Institute, Children’s Cancer Institute of Australia, and Cleveland Clinic Foundation. Rusnano agreed to provide up to $26 million in funding over a four-year period to Panacela, which maintains operations in Buffalo, New York, and Moscow, Russia. Cleveland BioLabs also has a 59-percent ownership in Incuron another Russian Federation-based joint venture (with Russian closed mutual venture fund, Bioprocess Capital Ventures) conducting clinical trials in Russia.
Roswell is running the trial that uses an Astex drug.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified August 2013 by Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer InstituteClinicalTrials.gov Identifier:
First received: April 12, 2013
Last updated: August 13, 2013
Last verified: August 2013
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