On Monday February 22, 2016 shares of Chimerix tumbled by 40% as the company announced that two phase 3 trials had to be stopped because of lack of efficacy. The phase 3 trial, known as the SUPPRESS trial, recruited a total of 452 patients. The patients that were recruited in the trial were those who were looking for prevention of the Cytomegalovirus — CMV — because of an underlying hematopoietic cell transportation — HCT.
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The primary endpoint of the trial was for Chimerix’s drug brincidofovir to prevent CMV infection in these patients over a 24-week period compared to a placebo compound. Patients were monitored for a total of 24-weeks in the study. It was split up into two different phases. One phase was where patients received treatment for a 14-week period, and the second phase was where patients were monitored over the course of the next 10-weeks.
Unfortunately at the end of the 24-week period the company’s drug brincidofovir failed to improve preventative CMV measures compared to the placebo compound, thus the trial failed to meet upon the primary endpoint. The company’s next step remains to discuss this finding with the FDA and determine if at least a subset of patients in the trial somehow benefited with the drug compared to placebo. The good news is that the company has not chosen to cut its other phase 2 trial in kidney patients that uses the same drug compound. Time will tell if the company can successfully advance this clinical compound to the market.
PTC Therapeutics (NASDAQ:PTCT)
On Tuesday February 23, 2016 shares of PTC Therapeutics tumbled by 60% after the company announced that the FDA determined that its Marketing Application for approval was insufficient for review. This biotech company has a drug compound, known as Translarna, that is being used to treat kids with a terrible disease known as Duchenne Muscular Dystrophy — DMD. This DMD is a disease in which boys have a degenerative muscle problem. This occurs because they don’t have enough dystrophin levels in the body to keep muscles in good order.
PTC Therapeutics isn’t the only company that is working on a drug for DMD. Other biotechnology companies that are working on drugs for DMD are Sarepta Therapeutics (NASDAQ:SRPT), and Biomarin Pharmaceuticals (NASDAQ:BMRN). The difference between PTC Thereapeutics drug and these other biotech company’s drugs are that they each treat a different subset of these DMD patients.
This insufficient application shouldn’t be all too surprising, because PTC had a problem with the trial a few months prior. Back in October of 2015 the company announced that it had failed to meet upon the primary endpoint of a phase 3 trial treating patients with DMD. Despite this setback the company believed that this failed data along with data from other previous trials would be enough to submit an application to the FDA for approval of Translarna.
The only problem is that investors don’t know if the FDA declared the application to be insufficient because of lack of efficacy or because the application was turned in with an incomplete fashion. Until more light is shed on the situation, investors should probably avoid the stock altogether as it continues to trade down. Matter of fact, today the share price of PTC closed flat as a lack of buyers didn’t help boost the stock.
Peregrine Pharmaceuticals (NASDAQ:PPHM)
On Thursday February 25, 2016 shares of Peregrine Pharmaceuticals fell by 62% after the company announced that it had to put a halt to its phase 3 trial, known as the SUNRISE trial. This phase 3 trial recruited up to a total of 600 patients to be treated in the second-line setting for non-small cell lung cancer — NSCLC. These patients either took Peregrine’s drug Bavituximab together with docetaxel, or they took docetaxel together with a placebo compound.
The trial was stopped early due too the recommendation of the independent data monitoring committee — IDMC. This committee is responsible for determining if a trial should be followed to completion dependent upon an interim analysis look into the data. The IDMC took a look into the data when 33% of targeted events — patient deaths — was reached. The committee noted that an interim analysis concluded that the Bavituximab group did not improve overall survival outcome compared to the placebo group.
With this trial failures the company was forced to halt all other trials that used Bavituximab in combination with Docetaxel. The company has other earlier state clinical problems and has approximately $67.5 million of cash on hand. Still the company has been in operation for 35 years and has yet to bring an approved product to market. The other trials may stand of chance of helping investors recover their losses, but they are not a guarantee. Investors dipping their toes in this stock should be highly cautious as any investment they put in may end up going nowhere.
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[Image Courtesy of Wikipedia]