Thursday, August 9, 2012

New failures of ”targeted” medicines

Well, it is not funny anymore – pharmaceutical company cannot develop sh…t when the market needs are so unmet! People become sick and die and the Pharma has to develop something helpful!

Failure No 1: monoclonal antibody again! - ganitumab:

Amgen Inc  said late Wednesday it was halting a late-stage clinical study of its drug ganitumab to treat pancreatic cancer that has spread because a review of the data indicated it didn't improve patient survival. The Phase III trial was adding ganitumab to the drug gemcitabine to see if it improved patient survival, compared with the use of gemcitabine alone. An early review of study results showed the addition of the drug would not likely result in a statistically significant improvement in patient survival rates, according to Amgen. The biotech firm said it will also discontinue the treatment in an ongoing Phase II trial for locally advanced pancreatic cancer.

Failure No 2: Talactoferrin alfa (a type of recombinant protein and a type of immunomodulatory protein).

German biopharmaceutical group Agennix has suffered a huge setback after its experimental lung cancer drug failed to hit its targets in a late stage clinical trial, casting a shadow of doubt over its future.

The group's stuck plunged nearly 80% after it revealed that a Phase III trial assessing its key drug talactoferrin in patients with non-small cell lung cancer (NSCLC) did not meet its primary endpoint in demonstrating an overall survival benefit.

The FORTIS-M trial looked at the effect of talactoferrin plus best supportive care (BSC) compared with placebo and BSC in patients with Stage IIIb/IV NSCLC, whose disease had progressed following two or more prior treatment regimens. 

However, results showed that median overall survival in the talactoferrin arm was just 7.5 months compared to 7.7 months for placebo, spelling the end for the development programme and even potentially the firm itself. 

Agennix' chief medical officer Rajesh Malik said the firm is "extremely disappointed and surprised with [the] results, especially considering the earlier promising results we had seen in two randomized Phase II trials".

The targeted approach sucks – and we know that! Which drug candidate will fail next?

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