Guest guest Posted December 14, 2006 Report Share Posted December 14, 2006 This has been a productive week for drug developer Vertex Pharmaceuticals (Nasdaq: VRTX). On Monday, it reported positive results from a phase 1 clinical trial for its potential leukemia treatment VX-680, which is partnered with Merck (NYSE: MRK); the drug will now move into phase 2 clinical development. Yesterday, Vertex announced interim results from a phase 2 trial for telaprevir, its developmental candidate for hepatitis C. The telaprevir results are much more significant to Vertex, since the drug is much further along in development, and being tested in a potentially much larger patient population. Initially, when the clinical trial results were announced, shares dropped nearly 8%. That was surprising, considering that the drug's efficacy in this phase 2 trial was consistent with its performance in earlier but much smaller trials of the drug. In this interim statistical analysis of one of its pivotal phase 2 trials, telaprevir plus standard care after 12 weeks of treatment left 88% of patients with undetectable levels of the hepatitis C (HCV) virus. The control arm of the trial only saw 52% of patients achieve this result. If these results hold up in the long run (which they usually do -- the pivotal twelfth week of treatment is a great predictor of a longer-term cure), telaprevir would be significantly more efficacious than the approximate 50% long-term cure rates seen for other genotype 1 HCV treatments. Importantly, this early response in such a large group of patients also holds the potential for those who take telaprevir to endure debilitating HCV drugs for a much shorter amount of time than the 48 weeks of treatment that most patients for genotype 1 HCV must undergo. This alone will provide a huge potential market for telaprevir. The reason for the negative initial market reaction to the trial results was probably related to the higher dropout rates and adverse events seen in the telaprevir arm of the trial, compared to the placebo arm. A reported 3% of patients taking telaprevir experienced serious adverse events, compared to only 1% of patients in the placebo arm. But with so few patients in the placebo arm, it's way too early to call these results meaningful. The higher level of adverse events seen in those taking telaprevir is obviously not good news, but given the significantly higher efficacy levels for the drug, they're not even close to stopping telaprevir from becoming one of the dominant forms of treatment for patients with genotype 1 HCV. Considering that as much as 25% of people infected with chronic HCV develop liver cirrhosis or liver cancer within 20 years of being infected, provided the disease progresses unchecked, few patients should have a problem taking their chances with telaprevir. There's still plenty of time left in the various arms of the telaprevir trials for further light to be shed on the drug's efficacy and safety. If telaprevir continues to show anything like the 80%-90% rate of undetectable HCV virus at end of its trials (and after the important six-month follow-up, after which patients can be considered cured), Vertex shareholders won't be dealing with too many more down days like yesterday. Vertex Pharmaceuticals is a Motley Fool Rule Breakers pick. Discover Gardner's entire portfolio of cutting-edge stocks with explosive growth potential when you try Rule Breakers free for 30 days. Merck is an Income Investor recommendation.Fool contributor Lawler does not own shares of any company mentioned Hillbilly Tim <knoxweb1@...> wrote: please, keep posting your info every week .how you feel,sides,etc. that will help me alot with my choice.Janet <doc_jade > wrote: Call me if you need to talk you through it. You know that I will be there for you. I am sure you can do this. Love JanetCheckers2001 <simplicity53gmail> wrote: Good morning everyone!It has been a beautiful week here in West Virginia. I have loved being able to sit on the back porch and look at the constellations in the evening. I even was able to take advantage of the sunshine and warmth and plant a few bulbs that someone kindly gave me. I have this wonderful yard here but didn't really have time or the tools to get much work done on it when I moved in. I'm already looking forward to the spring. I suppose we'll see snow again soon - hmm - maybe a few giant snow men.My first week of treatment went really well in terms of sides. First week's labs came back fine. I did have a real loss of appetite. I injected last Thursday evening and really had to force the eating. But Monday night I felt myself returning to a more normal me. I also had a lot of stomach cramping, lower back pain, etc., but all manageable. My son has been sick all week and I think my body is also fighting that. So tonights the night again! I almost wish I could have done an injection right after the first one (which I didn't quite do by myself!), but a week later and I am already sensing that my needle phobia is kicking in. So - I am bracing myself - telling myself that I can do this, practicing visualization - thinking if I can close my eyes the moment before and visualize it being done - open them and wham-o - it will be over. If only I didn't have to look lol. Wish me luck :-).Well, my best to everyone. It's good to know that I am not alone. I really appreciate all the posts and am thinking good thoughts for everyone. love & light, karenTake the ordinary things of life, and make them your own. Do the impossible with a smile Check out the all-new beta - Fire up a more powerful email and get things done faster. Tim Parsons knoxville,tn 37931 865-588-2465 x107 work www.knoxville1.com Need a quick answer? Get one in minutes from people who know. Ask your question on Answers. Tim Parsons knoxville,tn 37931 865-588-2465 x107 work www.knoxville1.com Everyone is raving about the all-new beta. Quote Link to comment Share on other sites More sharing options...
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