Sorry to pop your bubble but I cleared right away on the peg riba combo crap and stayed clear for the 7 months I was on the poison, NOTICE HOW THEY WORD THE PRESS RELEASE...."VX-950 in combination with two other leading hepatitis C drugs showed any tangible sign of the virus in their bloodstream after 28 days." the word TANGABLE mean less them 5ppm sorry folks not good enough when you stop taking the drugs in most cases the virus comes back, then there is the part about...."The 28-day study was not designed to measure how long the immune response could be sustained, according to the company....in other words they have no idea of the Sustained clearing of the virus,THIS IS NO CURE PEOPLE JUST ANOUTHER STOP GAP measure to breath life into decades old interferon drug.
interferon certainly ought to be replaced by more efficient and less toxic drugs, no doubt about that. Based on the presented data for VX-950 there might be a chance that at least in naive patients this product might be active enough for monotherapy. But most likely it will need to be combined either with intereferon and/or ribavirin. it will take the anounced further trials to clarify these issues and to come up with sufficient SVR data. bottom line: VX-950 is a promising development product that offers substantial improvement over todays Standard Of Care.
there is a product in early development that I am following closely now that might have the potential to become a interferon substitute: tarvacin from Peregrine (PPHM), you might want tp have a look at that one, too.
What you typed apparently was not said by the company. Here is the release:
Cambridge, MA, February 7, 2006� Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has completed dosing with VX-950 in a Phase II, 28-day clinical study in hepatitis C virus (HCV) infected patients. In addition, the Company announced that it has completed three-month animal toxicology studies that will support clinical studies of VX-950 of up to three months duration. Initiation of additional Phase II clinical studies in the U.S. in patients with HCV is planned following required Food and Drug Administration (FDA) review of these latest non-clinical and clinical results, and FDA review of a proposed clinical study protocol. This information will be submitted to the FDA within the first quarter of 2006.
Clinical Study Design and Results The 28-day, Phase II clinical study enrolled 12 treatment-na�ve patients with genotype 1 HCV. Patients received VX-950 in a tablet formulation at a dose of 750 mg every eight hours (q8h) for 28 days in combination with standard doses of pegylated interferon alfa-2a (Pegasys�; peg-IFN) and ribavirin (Copegus�; RBV). At the end of 28 days, patients completed dosing with VX-950 and per study protocol were required to continue treatment with peg-IFN and RBV. This 28-day Phase II study was not designed to evaluate sustained viral responses (SVR) in patients receiving VX-950.
There were no treatment discontinuations and no serious adverse events reported. A detailed safety analysis is ongoing.
For patients entering the study, the distribution of baseline plasma HCV RNA values was typical for a treatment-na�ve patient population. At the end of week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of quantitation (30 IU/mL; Roche Taqman� assay) in 6 of the 12 patients; and undetectable (less than 10 IU/mL; Roche Taqman� assay) in 2 of 12 patients. Preliminary HCV RNA results in patients for weeks 2-4 are as follows:
At the end of week 2, plasma HCV RNA was below the limit of quantitation (30 IU/mL) in 11 of the 12 patients; and undetectable (less than 10 IU/mL) in 3 of 12 patients. At the end of week 3, plasma HCV RNA was below the limit of quantitation (30 IU/mL) in 12 of the 12 patients; and undetectable (less than 10 IU/mL) in 9 of 12 patients. At the end of VX-950 dosing (end of week 4; day 28), plasma HCV RNA was undetectable (less than 10 IU/mL) in all 12 patients. No patients showed evidence of viral breakthrough while on treatment. The Phase II study reported today is the third in a series of clinical trials of VX-950 in patients with HCV designed to evaluate safety, pharmacokinetics and antiviral activity, in order to guide the design of larger, longer duration Phase II studies. The Company plans to present the full data set from the 28-day Phase II study at a medical conference later this year.
About Vertex Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company�s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex�s product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Before you get SVR, you have to get it undetectable (duh). I am not sure what your axe to grind is, but if SOC gets to <10 in 50% by week 12, and those attain SVR after sufficient treatment time, why can't VRTX get that when their drug did it by week 4? Not logical at all. That is not a release I have read, it looks pretty slanted negatively.