Vertex Pharmaceuticals 2008 line up

Just released news.

jasper

http://biz.yahoo.com/bw/080421/20080421006287.html?.v=1

Press Release Source: Vertex Pharmaceuticals Incorporated


Vertex Pharmaceuticals Reviews Clinical Advancements and Reports First Quarter 2008 Financial Results
Monday April 21, 4:01 pm ET  
--Telaprevir data in HCV patients who failed current therapies to be presented at EASL--
--Pharmacokinetic analyses in HCV patients show potential for twice-daily dosing of telaprevir--
--VX-770 for cystic fibrosis to advance based on positive results reported in March 2008--


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today reported consolidated financial results for the quarter ended March 31, 2008.
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“In the first quarter of 2008, we made important progress to advance and differentiate the profile of our hepatitis C virus protease inhibitor telaprevir,” said Joshua Boger, Ph.D., President and Chief Executive Officer of Vertex Pharmaceuticals. “The ADVANCE clinical trial, started in March, is the first Phase 3 study initiated for an HCV protease inhibitor and provides us with a potential first-to-market position in the treatment-naïve patient population. In addition, we will present early data in patients who failed prior treatment with pegylated interferon and ribavirin at EASL later this week that highlight telaprevir’s potential in this important patient population that has a high level of unmet need and limited treatment options.”

“Additionally, we continue to advance other proprietary drug candidates in our pipeline targeting important disease areas, and in March we announced promising early clinical results for the oral potentiator drug candidate VX-770 in patients with cystic fibrosis,” continued Dr. Boger. “Our broad development investment is supported by a balance sheet that we strengthened in the quarter by raising $400 million through debt and equity offerings, enabling us to end the quarter with $750 million in cash and marketable securities.”

Telaprevir Development Program

Phase 3 Development in Treatment-Naïve Population


In March, Vertex initiated and began patient dosing in a Phase 3 clinical trial of the investigational hepatitis C virus (HCV) protease inhibitor telaprevir. The Phase 3 ADVANCE trial is a global 3-arm pivotal trial that is focused on 24-week telaprevir-based regimens that utilize rapid viral response (RVR) criteria.
Vertex expects to complete enrollment of this trial during the fourth quarter of 2008 and expects to have sustained viral response (SVR) data from the study in the first half of 2010.
Two abstracts with data from the PROVE 1 and PROVE 2 clinical trials in treatment-naïve patients have been accepted for presentation during the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan, April 23-27, 2008. Key data to be presented include SVR24 data from all arms of PROVE 1 and SVR12 data from the control arm of PROVE 2.
Telaprevir Development in Patients Who Have Failed to Achieve SVR with Current Therapy


Vertex is conducting PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve an SVR with a previous pegylated interferon-based treatment. Vertex expects to complete an interim analysis of PROVE 3 in May and submit data to regulatory authorities in the United States and Europe.
Vertex is also conducting study 107, an open-label study that is enrolling patients with genotype 1 HCV who did not achieve an SVR with previous interferon-based treatment in the control arms of PROVE 1, PROVE 2 or PROVE 3. Preliminary data through week 12 from study 107 will be presented as a late-breaker poster at EASL.
Additional Telaprevir Clinical Trials

Vertex and Tibotec are evaluating the potential role of telaprevir in important HCV sub-populations as well as different dosing regimens for telaprevir.


Tibotec is conducting a Phase 2 clinical study in Europe to evaluate a twice-daily dosing schedule of telaprevir (1125mg every 12 hours) in combination with pegylated interferon and ribavirin, as compared to the current dosing schedule (750mg every 8 hours). The study is now fully enrolled. Preliminary evaluation of pharmacokinetics supports continuation of both the twice-daily and three times daily dosing arms in the study. Preliminary pharmacokinetic analyses of pre-dose samples taken on day 8 of dosing in approximately 50 patients in this study indicate that trough concentrations in those patients receiving a twice-daily dosing schedule are similar to trough concentrations of a three times daily dosing schedule, and are also similar to trough concentrations observed in PROVE 1 and PROVE 2. Additional safety and efficacy data from this ongoing Phase 2 study will be needed to further characterize telaprevir’s ability to be dosed in this twice-daily regimen.
Tibotec is also conducting Phase 2 studies to evaluate telaprevir in patients infected with genotype 2, genotype 3 and genotype 4 HCV.
Next-generation HCV protease inhibitor in Phase 1 clinical development


Vertex is advancing a portfolio of HCV protease inhibitors with potentially differentiated profiles. VX-500 is now being dosed in a Phase 1a clinical trial, and VX-813 is expected to enter Phase 1 development in the second half of 2008.
Updates on the status of telaprevir clinical trials are available at www.clinicaltrials.gov.

Pipeline of Novel Drug Candidates


Novel oral programs targeting protein defects that cause cystic fibrosis (CF) are advancing
In March, Vertex reported the first proof-of-concept data from Part 1 of a Phase 2a trial of VX-770, an investigational Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) potentiator compound for the treatment of CF. The interim analysis showed improved lung function and improved function of CFTR protein, as measured by changes in sweat chloride levels and changes in chloride ion transport in the upper airway as measured by changes in nasal potential difference, after dosing VX-770 as an oral agent for 14 days. Through 14 days of dosing, VX-770 appeared to be well-tolerated.
Vertex expects these data to be presented at the 31st European Cystic Fibrosis Society Annual Conference in Prague, June 11-14.
In the second quarter, Vertex plans to proceed to Part 2 of the trial, which will enroll approximately 18 patients with the G551D mutation in at least one allele for dosing of VX-770 up to 28 days.
Vertex is also conducting a Phase 1a trial of VX-809, an investigational CFTR corrector compound for the treatment of CF. Depending on the results from the Phase 1a trial, Vertex plans to initiate a Phase 1b trial in patients with CF in mid-2008.
Additional Advancements in Pipeline


Vertex expects to begin clinical development of a novel janus kinase 3 (JAK3) inhibitor, VX-509, with broad potential in the treatment of multiple immune-mediated inflammatory diseases, in mid-2008.
In the second quarter, Vertex’s collaborator, Merck & Co., Inc., is expected to initiate a Phase 1 clinical trial of the Aurora kinase inhibitor MK-5108 (VX-689) in patients with advanced and/or refractory tumors. Merck continues to evaluate efficacy and safety data for the Aurora kinase inhibitor MK-0457 (VX-680) for the treatment of cancer following the previously announced suspension of clinical trial enrollment for this compound.
In the first quarter, Vertex and GlaxoSmithKline ended their agreement for the development and commercialization of certain novel, subtype selective sodium channel modulators for the treatment of pain.

[4xTX]

I'm in the 107 study, it seems to work!

[CIRQDUSOLIEL]

I guess I've got that deer in the headlights look about what this all means.  Does this mean that these drugs will be here soon?  I'm a little confused about exactly what it's saying..........maybe you could put it in layman's terms for me if you've got a little time......thanks.

In Him,
Rick

[Dora82_05]

So, these trials are only for people who failed the regular therapy? No, untreated (or first timers) people with geno 1?

[4xTX]

try this website...should help to find a clinical trial for you

http://healthnews.uc.edu/clinicaltrials/

I thought I saw one for naive patients here
http://www.clinicaltrials.gov/ct/show/NCT00336479

[Bigfloyd]

Prove 3 is for GT 1 Peg/Riba failures. Not to be confused with the Phase 3 trial for GT 1 treatment naive.

[4xTX]

hey I wouldn't call us failures...:)  Just resilient!

[Bigfloyd]

As you know, failures occur for a variety of reasons including non-responder, relapser, treatment intolerance for physical and/or mental reasons, etc. I frankly don't know what criteria Vertex is using for Prove 3, but I would suspect it's focused on relapsers.  I am 63 into 67 total. I cannot imagine doing this again, but it's good to know there are other treatments in process. I hope the right one comes soon for you.