Genesis Biopharma, Inc. Expresses Support for FDA Codevelopment Guidelines
MANHATTAN BEACH, Calif., Jan. 24, 2011/PRNewswire/ -- Genesis Biopharma, Inc. (OTC Bulletin Board: GNBP), a biotechnology company developing targeted cancer therapies, today announced the company's support of the FDA's newly drafted "Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination." This guidance document, designed to encourage companies to collaborate and seek approval for successfully developed drug combinations, would support Genesis Biopharma's development of its anti-CD55 monoclonal antibody shown to have potentially broad application as a targeted cancer therapy.
In particular, this guidance would help enable the company's goal to form partnerships with pharmaceutical and biotechnology companies and to support clinical development efforts for their anti-CD55 monoclonal antibody.
"Genesis Biopharma's anti-CD55 program has the potential to expand and improve the clinical utility of already approved antibody therapies as well as some novel agents in development," said Robert Brooke, Genesis Biopharma President and CEO. "When this FDA guidance is finalized and approved, it will simplify efforts to form codevelopment partnerships and will ultimately ensure timely access to new and effective treatments for patients fighting currently sub-optimally treated conditions, such as metastatic cancer."
"The regulatory professionals now have a much needed tool to guide companies when developing combinations of two investigational products toward the much needed goal of making available safe and effective therapies," added Dr. Hana B. Moran of Moran Advisors, LLC.
About Genesis Biopharma, Inc.
Genesis Biopharma, Inc. is a development-stage biotechnology company engaged primarily in the development of targeted cancer therapies. For more information on the company, visit www.genesis-biopharma.com.
The foregoing press announcement contains forward-looking statements that can be identified by such terminology as "expect," "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.
SOURCE Genesis Biopharma, Inc.