|Neurocrine Announces Phase II Results of VMAT2; Regeneron Cholesterol Drug Faces Sudden Challenge|
|By Staff and Wire Reports|
|Monday, 26 March 2012 18:54|
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced efficacy and safety results from a Phase II trial of NBI-98854 in 37 tardive dyskinesia patients. For the final analysis, data from one site was removed due to the inconsistent and incorrect application of the efficacy assessment protocol. With this site removed, the results showed a significant reduction in tardive dyskinesia symptoms at end of two weeks of active treatment with 50mg once-daily doses of NBI-98854.
"This Phase II trial was extremely informative. NBI-98854 displayed the efficacy and safety data we expected to see in both the 12.5mg and 50mg doses," said Chris O'Brien, Chief Medical Officer of Neurocrine Biosciences. "While we had data inconsistencies at one site, this study has provided us with the necessary information and confidence to move forward into the larger Phase IIb trials as planned."
After database lock and unblinding of study data, the pre-specified statistical assessment was conducted and the normal quality control evaluation of the output performed. An inconsistent pattern of Abnormal Involuntary Movement Scale (AIMS) scores emerged at one of the eight sites that was not evident during the blinded data review. Potential errors in randomization and drug exposure as causes for this data inconsistency were ruled out. However, a review of videotaped AIMS assessments at this single site noted discrepancies between the clinical score and the video record which were well outside of the variability associated with the AIMS. Additionally, videotaped AIMS assessments were reviewed at other sites and found to be administered appropriately.
Based on these findings, the AIMS data from this single site was removed and the statistical assessment was repeated. This post-hoc analysis demonstrated a clinically meaningful and statistically significant improvement in tardive dyskinesia symptoms for the subjects while receiving the 50mg once-daily dose. These subjects had a significant reduction in tardive dyskinesia symptoms at the end of two weeks of active treatment vs. the end of two weeks of placebo (difference in LS mean of 4.2 for the 50mg period vs. the placebo period, p-value=0.002). As expected, the 12.5mg dosing group was not statistically better during the active treatment period than during the placebo period (difference in LS mean of 0.4 for the 12.5mg period vs. placebo period, p-value=0.68).
A new type of drug being developed by Regeneron Pharmaceuticals Inc (NASDAQ:REGN) slashed levels of cholesterol almost in half when given every four weeks, but fell short of reductions reported a day earlier with once-monthly injections of Amgen Inc's rival product.
Both monoclonal antibodies work by blocking a protein called PCSK9, and are shaping up to be the next big thing in preventing heart attack and stroke. Wall Street expects the new class of drugs, including those in earlier stages of development at Merck & Co (NYSE:MRK) and Bristol-Myers Squibb Co (NYSE:BMY), to generate annual future sales of up to $20 billion.
Regeneron is developing its entry, called REGN 727, in partnership with French drugmaker Sanofi (NYSE:SNY). The product, which has completed mid-stage trials and is heading toward far larger Phase III studies, has been considered to be the clear front runner.
Amgen's drug, AMG 145, is just entering mid-stage studies and is considered about a year behind REGN 727 in development. Although it is far less-known than the Regeneron antibody, stellar results from a Phase I trial of the Amgen product raised its profile considerably when reported on Sunday at the annual sessions of the American College of Cardiology in Chicago.
In the 51-patient study, patients receiving monthly injections of AMG 145 and taking low to moderate doses of statins had up to a 66 percent reduction in "bad" LDL cholesterol by the eighth week of the study. "We gave two doses, four weeks apart, and at the eighth week there was minimal tapering off" of the drug's potency, Clapton Dias, Amgen's medical services director, told Reuters. By contrast, data presented Monday at the Chicago heart meeting showed that the effect of REGN 727 in a mid-stage trial, when given at high doses every four weeks, tapered off unacceptably. "The cholesterol lowering was consistent at two weeks, but at four weeks you could see effectiveness of the drug begin to wane," its lead researcher, James McKenney, said in an interview.
"LDL began to come back up," said McKenney, who is chief executive officer of Richmond, Virginia-based testing company National Clinical Research. He speculated that future late-stage trials of REGN 727 will therefore likely be built around two-week dosing.
Given every two weeks, the Regeneron drug cut LDL levels up to 72 percent, McKenney said. That is roughly in line with maximum reductions of 75 percent seen with AMG 145. No serious side effects have been reported for either medicine.
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced results of analyses of atrial fibrillation (AF) data from the BEST trial, a previously conducted Phase 3 heart failure (HF) trial involving Gencaro (bucindolol hydrochloride), in 2,708 advanced heart failure patients.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced its schedule of preclinical data presentations to be made at the American Association for Cancer Research (AACR) Annual Meeting 2012, taking place Saturday, March 31 through Wednesday, April 4, 2012, in Chicago.
Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that it has reached the target enrollment in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer.
Deaf-Talk, Inc., dba DT Interpreting (PINKSHEETS: MGQG) (DTI), the industry leader in on-demand video sign language interpreting, announced today that its recently instituted DTVideoHub service continues a strong, steady growth of new healthcare facility clients, additional installations for existing clients and conversions of previously installed, older equipment to the state-of-the-art DTVideoHub technology.
Digirad Corporation (NASDAQ: DRAD) today announced that, in connection with its 2012 Annual Meeting of Stockholders, it intends to add up to three new independent members to its Board of Directors.
Galectin Therapeutics Inc. (NASDAQ: GALT) (NASDAQ: GALTU) announced the full exercise of the over-allotment option granted to the underwriter to purchase 173,916 additional units, at a public offering price of $9.00 per unit, less the underwriting discount, in connection with its previously announced underwritten public offering of 1,159,445 units, bringing total gross proceeds from the offering to approximately $12 million.
Illumina, Inc. (NASDAQ:ILMN), a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, today sent a second letter to its stockholders outlining Illumina’s unrivaled track record of superior operational performance and financial success.
Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today announced that they will collaborate on a multiproduct agreement for the development, supply and distribution of alternative dosage form products.
Kips Bay Medical (NASDAQ: KIPS) announced that effective March 27, 2012, the Nasdaq Listing Qualifications Staff granted the Company’s request to transfer its listing to the Nasdaq Capital Market from the Nasdaq Global Market.
McKesson Corporation (NYSE:MCK) announced that it has completed the previously announced acquisition of the independent banner and franchise businesses of Katz Group Canada Inc. in an all cash transaction that closed March 25th, 2012.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has received formal notification of recommendations from the National Institutes of Health (“NIH”) Recombinant DNA Advisory Committee (“RAC”) reflecting the Company’s successful presentation of study findings during a meeting held on March 8, 2012.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of neurological complications of diabetes announced that Chief Executive Officer Shai N. Gozani, M.D., Ph.D. has been interviewed on CEONEWS.Tv, a financial news network.
Nuvilex, Inc. (OTCQB:NVLX), an emerging international biotechnology provider of cell and gene therapy solutions through its associate SG Austria, announced today a significant advance in gene therapy with a new, unique, and specialized system for induction of gene expression in encapsulated cells.
Hoji Alimi, founder and CEO of Oculus Innovative Sciences, Inc. (NASDAQ: OCLS), in an exclusive, candid interview with BioMedReports, answers questions about whether his company will ever become a profitable and successfully commercialized biotechnology firm.
Last week, shares of Pozen Inc. (NASDAQ: POZN) -- a developer of novel pharmacologic agents primarily for pain and pain-related conditions -- rose the most in four months after announcing positive top-line results from two pivotal Phase 3 clinical trials.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that nonclinical data on the immunologic mechanism of action of PV-10, presented at the 2012 Society of Surgical Oncology Annual Meeting, confirms that PV-10 chemoablation of melanoma lesions leads to a systemic response and the induction of systemic anti-tumor immunity.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, announced today the addition of Stephanie H. Astrow, Ph.D., as the Company’s Vice President for Research and Development.
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the Journal of Clinical Oncology (JCO) published results of the company’s pivotal clinical trial of ADCETRIS™ (brentuximab vedotin) in Hodgkin lymphoma (HL) patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT).
Sunshine Biopharma, Inc. (OTCBB: SBFM), which has designed and synthesized a new compound, Adva-27a, that acts as an inhibitor of multidrug resistant breast cancer cells in vitro, today announced that it will be presenting new scientific data at the American Association for Cancer Research Meeting March 31-April 4, 2012, in Chicago, Illinois, together with its research collaborator, Binghamton University, a State University of New York.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells (CSCs), congratulates Robert Weinberg, Ph.D., Verastem co-founder and co-chair of the Scientific Advisory Board, and announces the presentation of preclinical data at the American Association for Cancer Research annual meeting being held March 31 to April 4, 2012, in Chicago, IL.