Genesis Biopharma Receives FDA Meeting Minutes from Cōntego™ Pre-IND Meeting
LOS ANGELES--(BUSINESS WIRE)-- Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cellular immunotherapies for the treatment of cancer, today announced receipt of meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Investigational New Drug (IND) application submission meeting for Cōntego™ held on August 23, 2012.
"This correspondence represents a significant step in delineating the path forward for Cōntego™ for the treatment of Stage IV metastatic melanoma, and we continue to be pleased with our interactions with FDA," stated Anthony J. Cataldo, Chief Executive Officer of Genesis Biopharma. "We appreciate the time FDA spent with us, and look forward to our continuing dialogue with FDA as we advance Cōntego™ toward product registration."
Genesis Biopharma is developing Cōntego™, a ready-to-infuse adoptive cellular immunotherapy (ACT) using tumor infiltrating lymphocytes (TILs) for the treatment of Stage IV metastatic melanoma. TILs are immune cells which have invaded a patient's tumor in an attempt to destroy it. Dr. Steven Rosenberg, Chief of the Surgery Branch at the National Cancer Institute, developed the process whereby TILs are isolated directly from the patient's tumor, multiplied to great numbers ex vivo, and infused into the patient to destroy the patient's cancer. Cōntego™ is based on the TIL therapy developed by Dr. Rosenberg for the treatment of patients with Stage IV metastatic melanoma.
According to National Cancer Institute estimates, in 2012 there will be more than 76,000 new cases of melanoma in the U.S. and more than 9,000 deaths.
About Genesis Biopharma, Inc.
Genesis Biopharma, Inc. is engaged in the development and commercialization of autologous cell therapies for the treatment of various cancers. The Company's lead product candidate, Cōntego™, is a ready-to-infuse autologous cellular immunotherapy utilizing tumor infiltrating lymphocytes for the treatment of patients with Stage IV metastatic melanoma.
For more information about the company, visit www.genesis-biopharma.com.
The foregoing announcement contains forward-looking statements that can be identified by such terminology as "expects," "hopes," "potential," "suggests," "bodes," "may," "should," "could," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding future research, development and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the company's ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as of the date they are made. The company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.
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