Genesis Biopharma says FDA Co-development Guidelines will help with its anti-CD55 MAb

US biotech firm Genesis Biopharma (OTC Bulletin Board: GNBP), which is developing targeted cancer therapies, says that it supports the Food and Drug Administration's newly-drafted "Guidance for Industry Co-development of Two or More Unmarketed Investigational Drugs for Use in Combination."

This guidance is intended to assist sponsors in the co-development of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during co-development. It is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.

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.