|Merck Says Committee Recommending Continuation for MK-8931; Spectrum Submits NDA for Belinostat|
|By Staff and Wire Reports|
|Tuesday, 10 December 2013 20:30|
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided an update on the development program for MK-8931, a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase II/III “EPOCH” study in patients with mild to moderate Alzheimer's disease recently completed its planned interim safety analysis and recommended that the trial continue to recruit patients, with no changes to the protocol.
The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least 3 months. Based upon the DMC's recommendations, Merck will continue enrollment of the EPOCH study. In addition, Merck will initiate dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer's disease, also known as prodromal Alzheimer's disease.
“We are pleased to receive the DMC's recommendation and look forward to continuing the clinical development program for MK-8931,” said Dr. David Michelson, vice president, Neuroscience, Merck Research Laboratories. “Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer's disease grows.”
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, announced today the that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Belinostat, a pan-histone deacetylase (HDAC) inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). Belinostat is differentiated from other HDAC inhibitors that selectively inhibit a single class of HDAC enzymes by virtue of its inhibition of all 3 classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV); this leads to different alterations in histone and non-histone protein acetylation that, in turn, could importantly influence chromatin accessibility, gene transcription, and activity in different cancer patients, including those who develop drug resistant disease.
“While important strides have been made in treating patients with PTCL, this is a deadly disease and remains an unmet medical need with approximately 70% of patients failing current therapies,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Based on the clinical data, belinostat was shown to have an acceptable safety profile and clinical efficacy, with complete responses in heavily pretreated patients. In June, data was presented at an oral session at ASCO which demonstrated the clinical activity of belinostat in treating patients (N=129) with R/R PTCL with an overall response rate of 26% in these heavily pretreated patients that included patients who had received a previous allogeneic or autologous stem cell transplant.”
Amgen (NASDAQ: AMGN) and its subsidiary Onyx Pharmaceuticals, Inc. today announced that they will hold a post American Society of Hematology (ASH) summary webcast on Wednesday, Dec. 11, 2013, at 11 a.m. PST.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the Centers for Medicare and Medicaid Services (CMS) has created a new Ambulatory Payment Classification (APC) that includes both in-hospital endovenous radiofrequency (RF) treatments and in-hospital endovenous laser varicose vein ablation, such as the Company's VenaCure EVLT procedure.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and twelve-months ended September 30, 2013.
BG Medicine, Inc. (Nasdaq:BGMD) announced today that the Centers for Medicare and Medicaid Services (CMS) have published the final determination of the 2014 Medicare national limitation amount for the Company's galectin-3 blood test (analyte-specific CPT® Code 82777) at the amount of a crosswalked test (analyte-specific CPT® Code 84244) whose 2014 national limitation amount is $30.01.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today positive results from a preclinical combination study of CDX-301 (FMS-like tyrosine kinase-3 ligand or Flt3L) and Mozobil® (Plerixafor injection, formerly AMD3100) demonstrating that the combination of these agents significantly increases hematopoietic stem cell mobilization in mice.
Champions Oncology (OTC:CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, in conjunction with Barnabas Health, successfully enrolled the first patient in a groundbreaking breast cancer research trial.
Champions Oncology (OTC:CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, announced today that it will announce its financial and operational results for the second quarter ended October 31, 2013 after the market closes on Thursday, December 12.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 40 new employees.
PDL BioPharma, Inc. (NASDAQ: PDLI) today announced revenue guidance for the fourth quarter ending December 31, 2013, of approximately $109 million, as compared with actual revenue of $86 million for the fourth quarter of 2012, an approximate 27 percent increase.
Pharmacyclics, Inc. (NASDAQ: PCYC) today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55th Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.
PPJ Enterprise (OTC Pink: PPJE), a proprietary automated health care software company, is pleased to share a current update with the company followers regarding the current issues.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that it has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for the clinical development of RP103 as a potential treatment for Leigh syndrome and other mitochondrial disorders. RP103 is currently marketed in the U.S. as PROCYSBI® (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis in adults and children 6 years and older.
Receptos, Inc. (Nasdaq:RCPT) announced today that Ono has elected to amend and expand the existing collaboration agreement between the parties to include transfer to Ono of the Receptos G-protein-coupled receptor (GPCR) technology platform, a proprietary high resolution protein crystal structure determination technology which enables rational drug design for the GPCR therapeutic target class.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of an investigator-sponsored trial of vosaroxin in combination with azacitidine in patients with myelodysplastic syndrome (MDS).