News Column

Synta Announces Ganetespib Into Phase 3 Extension Of AML LI-1 Study; Ignyta Announces Phase I/II Clinical Trial Of RXDX-101

July 23, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 21, 2014.

{nfg}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'sNational 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.”









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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.









Also Monday:






Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, today announced that it has secured cGMP manufacturing of ANAVEX 2-73 for its drug candidate trial supplies.



AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today receipt of an Innovative Technology Contract for the Company's BioFlo PICC and BioFlo Port products from Novation, the leading health care supply chain expertise, analytics and contracting company.



Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the company has presented data from its research involving AGS-004, the company's investigational fully personalized immunotherapy for HIV, at the International AIDS Society (IAS) Towards a Cure Symposium that was held at the Victoria University City Convention Centre in Melbourne, Australia.



Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced preliminary unaudited results for the second quarter of 2014.



Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics focused on developing genomic-based oncology tests and services, today announced the signing of a definitive agreement to acquire privately held Gentris Corporation, a global provider of clinical pharmacogenomics solutions, next-generation sequencing, and biomarker testing.



Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company applying its leadership position in the field of gene therapy and calcium dysregulation today announced an exclusive, global license from Enterprise Partners Venture Capital for gene therapy applications of the membrane-bound form of the Stem Cell Factor gene (mSCF) for treatment of cardiac ischemia.



Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in the development, assembly, marketing and sale of medical devices and sleep respiratory products in China, today announced that it showcased the current line of sleep respiratory solution at the 5th Chinese Sleep Medicine Congress ("CSMC") in Nanchang, Jiangxi Province, from July 11-13, 2014.



ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its second quarter 2014 earnings release conference call.



Natural Health Trends Corp. (OTCQB:NHTC)
, a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced that management will conduct a conference call to discuss its financial results for the quarter ended June 30, 2014.



PetMed Express, Inc. (Nasdaq:PETS)
today announced its financial results for the quarter ended June 30, 2014.



Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today that it will issue its 2014 second quarter earnings release after close of market on Wednesday July 30, 2014.



Stereotaxis, Inc. (Nasdaq:STXS)
today announced that it will present at the 29th Annual Meeting of the Japanese Heart Rhythm Society in Tokyo beginning July 23, 2014.



TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company, today announced preliminary clinical results from its ongoing Phase I study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody in combination with TGR-1202, the Company's novel, once-daily PI3K delta inhibitor in patients with advanced CLL and non-Hodgkin's lymphoma.



Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced an update on the TKM-Ebola Phase I clinical hold.




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Source: BioMed Reports


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