Update Telaprevir;Vertex Plans US Phase 2 Post-Transplant Study

The recent progress update mentioned that Vertex will be calling Telaprevir "INCIVEK",  noted previously Merck's boceprevir has been registered as  VICTRELIS.

In the fourth quarter of 2011, Vertex plans to initiate a Phase 2 study in the U.S. of INCIVEK dosed in combination with pegylated-interferon and ribavirin in people with recurrent hepatitis C following a liver transplant.

In the third quarter of 2011, Vertex plans to initiate a clinical trial to evaluate a 12-week treatment regimen of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene.

See below for all trial updates......

CAMBRIDGE, Mass. --(Business Wire)--
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided an update on recent progress in its key development programs, discussed upcoming milestones and reported consolidated financial results for the quarter ended March 31, 2011. 


EXCERPT;

See Full  May 3rd Press Release

Recent Clinical Development Progress
Vertex today reviewed recent progress in its clinical development programs and provided the following updates:
Hepatitis C:
Preparing for Launch of INCIVEKTM (telaprevir)

  • Vertex today announced that it intends to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S.
  • Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
  • Vertex's collaborator, Janssen-Cilag International NV, is awaiting a formal decision from the European Medicines Agency (EMA (News - Alert)) on its Marketing Authorisation Application (MAA) for telaprevir in the EU. The EMA accepted telaprevir for accelerated assessment, which is granted to new medicines of major public health interest. Vertex believes that Tibotec, a division of Janssen-Cilag, may receive a response on the MAA in the second half of 2011.
  • Vertex's entire commercial function is in place and prepared for the planned launch of INCIVEK (telaprevir). Approximately 200 field-based employees have been hired to date to support the future use of INCIVEK (telaprevir) across the United States following the planned launch, including a sales team of 115 therapeutic specialists and others who will support the future sale of INCIVEK (telaprevir).
Phase 3b Study of Twice-daily Dosing of INCIVEK (telaprevir)
  • Patient enrollment is ongoing in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (telaprevir; 1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (telaprevir; 750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. The study, known as OPTIMIZE, does not include a control arm of pegylated-interferon and ribavirin alone. Sustained viral response (SVR or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily (BID) dosing of INCIVEK (telaprevir) by the end of 2012.
Phase 2 Combination Study of INCIVEK (telaprevir) and VX-222
  • Vertex is conducting a Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of INCIVEK (telaprevir) dosed in combination with Vertex's lead investigational polymerase inhibitor, VX-222, for the treatment of hepatitis C. The study currently includes three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of INCIVEK (telaprevir; 1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), pegylated-interferon and ribavirin. Vertex expects to complete enrollment in the second quarter of 2011 in a three-drug treatment arm that will evaluate an all-oral, interferon-free regimen of INCIVEK (telaprevir; 1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily. A final arm may be added to the trial per protocol based on data from other arms of the study. In April, Vertex announced interim results from this study and expects to present additional data from the study in the second half of 2011.
Phase 3 Study of INCIVEK (telaprevir) in People Co-infected with the Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)
  • In February, Vertex reported interim results from a Phase 2 clinical trial of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin in people who are infected with genotype 1 chronic hepatitis C and HIV. Based on these results, Vertex plans to initiate in the second half of 2011 a Phase 3 study of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin in people co-infected with HCV and HIV. The Phase 3 trial will be designed to generate data that, if positive, could support the submission of a supplemental NDA for this population.
Phase 2 Study of INCIVEK (telaprevir) to Evaluate 3-month Treatment Regimens
  • In the third quarter of 2011, Vertex plans to initiate a clinical trial to evaluate a 12-week treatment regimen of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. In April, Vertex announced data from retrospective analyses that evaluated the relationship between variations at the IL28B gene and a patient's response to treatment with INCIVEK (telaprevir), pegylated-interferon and ribavirin. These data support the initiation of the study to evaluate 12-week treatment regimens for certain patients.
Phase 2 Post-Transplant Study of INCIVEK (telaprevir)
  • Earlier in 2011, Vertex completed a drug-drug interaction study of INCIVEK (telaprevir) dosed with immunosuppressive agents that are commonly used following a liver transplant. In the fourth quarter of 2011, Vertex plans to initiate a Phase 2 study in the U.S. of INCIVEK dosed in combination with pegylated-interferon and ribavirin in people with recurrent hepatitis C following a liver transplant.

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