Infinity Pharmaceuticals hedgehog inhibitor IPI-926

List of Clinical Hedgehog Pathway Cancers

Infinity Pharmaceuticals hedgehog inhibitor IPI-926

Postby hedgehog » Mon Feb 08, 2010 6:56 pm

Advanced and/or Metastatic Solid Tumor Malignancies PI
http://clinicaltrials.gov/ct2/show/NCT00761696?term=IPI-926
A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies

A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer PI/PII
http://clinicaltrials.gov/ct2/show/NCT01130142
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.
Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).
  • Estimated Enrollment: 130
  • Study Start Date: April 2010
  • Estimated Study Completion Date: March 2012
  • Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer PI
http://clinicaltrials.gov/ct2/show/NCT01255800
The purpose of this study is to determine the dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab in patients with advanced head and neck cancer.
This study will evaluate the clinical activity of the combination of IPI-926 in combination with cetuximab in patients with advanced head and neck cancer
  • Estimated Enrollment: 24
  • Study Start Date: March 2011
  • Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma PI
http://clinicaltrials.gov/ct2/show/NCT01310816
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma. Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
  • Estimated Enrollment: 108
  • Study Start Date: February 2011
  • Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)



http://clinicaltrials.gov/ct2/results?term=IPI-926
hedgehog
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Re: Infinity Pharmaceuticals hedgehog inhibitor IPI-926

Postby hedgehog » Sat Feb 27, 2010 5:06 pm

Product Candidate: IPI-926

    IPI-926 is a novel, potent, orally-available small molecule inhibitor of the Hedgehog pathway. Malignant activation of the Hedgehog pathway is implicated in multiple cancer settings and Infinity's development strategy is designed to enable IPI-926 to target a broad range of critical oncology targets - from the tumor cell to the cancer microenvironment. This broadly applicable, targeted approach represents an innovative method for fighting cancer and has potential in treating a range of cancers, including pancreatic cancer, small cell lung cancer, ovarian cancer, bladder cancer, medulloblastoma, basal cell carcinoma, and certain hematological malignancies.

    Infinity is currently evaluating IPI-926 in a Phase 1 trial in patients with advanced solid tumors. Data from this trial are expected to be presented in 2010, and Infinity anticipates initiating Phase 2 development later this year.

    Infinity has reported preclinical data on IPI926 demonstrating significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth. For all scientific publications relating to IPI-926 and the Hedgehog signaling pathway, click here.

    Infinity has an issued U.S. patent broadly covering the composition of matter of a genus of compounds, including IPI-926, useful for modulating the Hedgehog signaling pathway.

Hedgehog Pathway
http://www.infi.com/video4.swf
    The Hedgehog signaling pathway represents a new way of understanding and potentially attacking the progression and reoccurrence of cancer. The Hedgehog pathway is normally active during embryonic development and regulates tissue and organ formation. Malignant activation of the Hedgehog pathway is believed to play a central role in allowing the proliferation and survival of cancer cells, including pancreatic, prostate, small cell lung, breast, and hematologic cancers, as well as certain skin and brain cancers.

How Does Hedgehog Pathway Inhibition Function?
http://www.infi.com/images/MOA-Hedgehog.swf
    Infinity is developing a novel, proprietary Hedgehog pathway inhibitor,
    IPI-926. In preclinical models, IPI-926 has shown potent and selective inhibition of the Hedgehog pathway, anti-tumor activity, and attractive pharmacologic properties, including oral bioavailability and favorable half-life. IPI-926 is currently being evaluated in a Phase 1 clinical trial and is part of Infinity's global strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited.

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