|Synta Announces Ganetespib Into Phase 3 Extension Of AML LI-1 Study; Ignyta Announces Phase I/II Clinical Trial Of RXDX-101|
|By Staff and Wire Reports|
|Monday, 21 July 2014 19:14|
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 (less intensive) trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine (Ara-C), in newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who are not eligible for intensive chemotherapy. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date.
Advancement into the Phase 3 extension follows an interim analysis of results from 50 patients who received the ganetespib-cytarabine combination in the Phase 2 portion of the trial. The primary efficacy outcome in Phase 2 was rate of complete response. Per protocol, the Phase 3 extension will include an interim futility analysis and enroll approximately 200 patients in the ganetespib-cytarabine and the cytarabine alone arms, for a total of approximately 400 patients. The primary efficacy endpoint for the Phase 3 extension will include overall survival. The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized.
The AML LI-1 trial is the first of three multicenter, randomized studies supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK to include a ganetespib treatment arm. AML LI-1 is being conducted under the auspices of the UK's National Cancer Research Institute (NCRI) Haematological Oncology Study Group, with investigators in Denmark, France, New Zealand, and the UK, and under the sponsorship of Cardiff University, UK. The other two studies, to be initiated later this year, are the AML-18 trial, evaluating ganetespib with standard DA (daunorubin and Ara-C) in patients over 60 years old who can tolerate intensive chemotherapy, and the AML-19 trial, evaluating ganetespib in combination with conventional chemotherapy in younger patients with AML.
“AML LI-1's ‘pick-the-winner' trial design is intended to rapidly assess new therapeutics with the potential to improve outcomes in very difficult to treat patients with AML and MDS,” said Professor Alan K. Burnett, Head of Haematology at Cardiff University and Chief Investigator of the AML LI-1 trial. “We look forward to continuing the ganetespib-cytarabine combination study in this population, and to further evaluating ganetespib's full potential in AML through the comprehensive research program developed by the UK NCRI Group, which includes the AML-18 and AML-19 trials.”
“Ganetespib's progress in the AML LI-1 study underscores the potential of Hsp90 inhibition across a broad range of cancers,” said Dr. Vojo Vukovic, Chief Medical Officer, Synta. “We look forward to elucidating this potential through large, randomized studies, including the ongoing Company-sponsored GALAXY-2 Phase 3 trial in advanced non-small cell lung adenocarcinoma and investigator-sponsored trials in AML/MDS, breast cancer and ovarian cancer.”
Ignyta, Inc. (Nasdaq: RXDX), an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations.
“We are excited to be able to expand the clinical dosing of this product candidate to patients at leading cancer centers in the U.S., Europe and Asia,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “The initiation of the STARTRK-1 trial builds on the momentum of our presentation of interim data from the ongoing RXDX-101 Phase I clinical trial at the ASCO annual meeting, where we reported partial responses in patients with each of TrkA, ROS1 and ALK alterations, as well as in three different tumor types.”
“The emergence of cancer therapies targeted to specific genetic alterations is an important advance in the treatment of solid tumors,” said Alexander Drilon, M.D., a medical oncologist in the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and a principal investigator in the STARTRK-1 trial. “This trial will help elucidate the clinical effects of RXDX-101, which inhibits pan-Trk, ROS-1 and ALK proteins, and allow us to better understand the drug's potential to help these very sick patients.”
The trial will involve multiple clinical sites in the U.S., Europe, and Asia. Sites that Ignyta anticipates will dose patients in the Phase I portion of the trial include Chao Family Comprehensive Cancer Center at UC Irvine, Lombardi Comprehensive Cancer Center at Georgetown, Massachusetts General Hospital/Dana Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Sarah Cannon Research Institute, and the University of Texas M.D. Anderson Cancer Center.
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