|Amarin Announces FDA Review Division Response on Amarin's ANCHOR SPA Agreement; Galectin Supports Investigational New Drug Application for GR-MD-02|
|By Staff and Wire Reports|
|Wednesday, 15 January 2014 20:24|
Amarin Corporation plc (Nasdaq: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) notified the company today that a determination on Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed. FDA previously notified the company that it planned to convey its decision to Amarin no later than January 15, 2014. In today's communication, DMEP provided no definitive date for its planned response. Based on dialogue with DMEP, Amarin does not expect the delay to be for a significant period of time.
There can be no assurance that Amarin will be successful in its effort to reinstate the ANCHOR SPA agreement or obtain a label expansion reflecting the ANCHOR clinical trial data.
Vascepa is FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. The ANCHOR Supplemental New Drug Application (sNDA) seeks approval of Vascepa for use as an adjunct to diet and exercise for adult patients on statin therapy with mixed dyslipidemia (one or more lipid disorder) and triglyceride levels between 200 and 499 mg/dL.
Galectin Therapeutics (NASDAQ: GALT) announced that Providence Portland Medical Center filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) on December 27, 2013 to study GR-MD-02 in combination with Yervoy® (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. GR-MD-02 is Galectin Therapeutics' proprietary molecule that binds to and inhibits galectin proteins, predominantly galectin-3.
The application was prompted by findings from a preclinical study led by tumor immunology expert William L. Redmond, Ph.D., of the Providence Portland Medical Center's Earle A. Chiles Research Institute (EACRI). The preclinical study found that GR-MD-02 increased tumor shrinkage and enhanced survival in immune competent mice with prostate and breast cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a role for GR-MD-02 in cancer immunotherapy.
“The IND filing to study GR-MD-02 in conjunctive use with Yervoy in patients with metastatic melanoma is an important milestone for both Providence Portland Medical Center and Galectin Therapeutics,” said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. “Preclinical data have shown that GR-MD-02 holds immense potential for increasing the effectiveness of other therapies and may be an important approach in enhancing cancer immunotherapy.” If the application is approved by the FDA, the Phase 1B study will be conducted by the EACRI under principal investigator Brendan D. Curti, M.D. EACRI and Providence Cancer Center researchers have been leaders in immunotherapy research and translational clinical trials in melanoma and other cancers.
“The Phase 1B study will determine if GR-MD-02 enhances the probability of melanoma response with ipilimumab by inducing proliferation, activation and memory function of CD8+ T cells,” said Dr. Curti, the trial's principal investigator, a medical oncologist and director of the Providence Biotherapy Program at EACRI. “The combination of GR-MD-02 and ipilimumab has a strong scientific rationale based on Dr. Redmond's laboratory work. This study represents a novel approach for patients with metastatic melanoma.”
The study will employ a 3+3 Phase 1 design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition. Galectin Therapeutics will provide its proprietary compound GR-MD-02 to EACRI researchers, as well as supply researchers with supporting analysis of the pharmacokinetics of GR-MD-02 and the right to reference the Company's open IND on GR-MD-02.
Separately, the Cancer Centre at the Cliniques universitaires Saint-Luc and the Ludwig Institute for Cancer Research (LICR), in agreement with Galectin Therapeutics, placed on hold its Phase 1/2 trial evaluating the safety and efficacy of another galectin inhibitor, GM-CT-01, in combination with an experimental peptide vaccine for the treatment of advanced metastatic melanoma. Dr. Jean-Francois Baurain, the trial's principal investigator, medical oncologist and director of the melanoma clinic of the Cancer Center at CUSL, said, “The trial was unable to enroll sufficient patients with advanced stage melanoma due to the high selection criteria of patient candidates for the peptide vaccine and the recent availability of Yervoy in Europe as a treatment increasing the overall survival of metastatic melanoma patients.” A total of three patients completed the trial with no serious adverse events attributed to drug treatment and with two patients having a mixed response and one having progressive disease.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced that both CSO Dr. John Commissiong and President & CEO Gerald Commissiong are among the selectees for the 14th Annual 50 Most Important African-Americans in Technology.
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) notified the company today that a determination on Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed.
Chart Industries, Inc. (Nasdaq:GTLS), a leading independent global manufacturer of highly engineered equipment used in the production, storage and end-use of hydrocarbon and industrial gases, today announced the launch by its BioMedical business segment of the MVE HEco Series of cryogenic storage freezers.
CollabRx, Inc. (Nasdaq:CLRX), a leading data analytics company, today announced that its newest Therapy Finder for breast cancer patients will be made available in connection with the Cynvenio ClearID™ Breast Cancer genomic blood test.
CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company commercializing its European Union approved CytoSorb® blood purification therapy to treat life-threatening illnesses in the intensive care unit, issues a shareholder letter authored by its Chief Executive Officer, Dr. Phillip Chan, MD, PhD.
First Choice Healthcare Solutions, Inc. (OTCQB: FCHS), a diversified holding company focused on delivering clinically superior, patient-centric, multi-specialty care through state-of-the-art medical centers of excellence, today announced that the Company is scheduled to present at "TEN," Noble Financial Capital Markets' Tenth Annual Equity Conference to be held January 19-22, 2014 at Club Med's Sandpiper Bay Resort & Spa in Port Saint Lucie, Florida.
FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that Thijs Spoor, Chairman & CEO of FluoroPharma Medical, will present at the Noble Financial Capital Markets' Tenth Annual Equity Conference at Club Med in Sandpiper, Florida on Monday, January 20th at 2:30PM Eastern Time in Room 1.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that Providence Portland Medical Center filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) on December 27, 2013 to study GR-MD-02 in combination with Yervoy® (ipilimumab) in a Phase 1B study of patients with metastatic melanoma.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has completed the acquisition of DuraSeal® product lines from Covidien.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that it has secured an exclusive option from Massachusetts General Hospital to license intellectual property related to a novel approach for multiplexed protein analysis using the company's nCounter Analysis System.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio products and solutions, today announced that it has completed its merger with privately-held Turtle Beach, the market leader in video game audio.
Sigma-Aldrich Corporation (NASDAQ: SIAL), a leading Life Science and High Technology Company, will hold its quarterly conference call to discuss fourth quarter and full-year 2013 financial results on Thursday, February 6, 2014, at 11:00 AM Eastern Time.
Zealand Pharma A/S (NASDAQ OMX Copenhagen:ZEAL) announces that under its license agreement with Sanofi (EURONEXT:SAN) (NYSE:SNY) covering Lyxumia(r) (lixisenatide) and any combination product including lixisenatide, a milestone has been achieved in the advance of LixiLan, the once-daily single injection Lantus(r) (basal insulin) / Lyxumia(r) (lixisenatide) combination product, towards start of Phase III development in the 1st quarter of 2014.