This piece comes from Xconomy and notes that Merck and Sanofi are joining forces to test new cancer drugs in combination - a trend that appears to be gaining traction with other players in the oncology field as well. Combination therapies are often used in cancer. However, historically the combinations weren't tested together until each drug separately reached a fairly late stage (or was already approved). Now we have companies developing philosophies to test drugs in combination at an early stage of clinical trials. This is particularly popular in the treatment of cancer as frequently several signalling pathways that could affect the disease may be simultaneously attacked.
Previously, Merck and AZ have teamed up with their respective AKT and MET inhibitors. Now Merck and Sanofi plan to test their SAR245408 and SAR245409 inhibitors of the PI3K/mTOR pathway. Both partners will test each other's drug in combination with their own in Phase I trials.
The FDA issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. In addressing the new guidelines, FDA commissioner Margaret Hamburg said they are the result of a growing understanding that experimental therapies may need to be used together in order to be more effective or to prevent drug resistance.
Despite the excitement, efforts to study investigational drugs in combination are still in their infancy. Phase I is the first stage of clinical testing, so these new drug “cocktails” are still several years from reaching the market. Scientific, clinical, regulatory and intellectual property hurdles all must all be overcome if these novel combinations are to provide breakthrough cancer therapies for the patients who desperately need them.
Posted by Bruce Lehr December 30th 2010.