Reco Pharma Says Trial Study Not Seen Reaching Statistical Significance; FDA Removes Partial Clinical Hold on OncoMed's Ipafricept Print E-mail
By Staff and Wire Reports   
Thursday, 04 September 2014 22:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 4, 2014.
Recro Pharma, Inc. (Nasdaq: REPH), a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of pain, initially for acute pain following surgery, announced a clinical strategy update following findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the Company's REC-13-012 trial. The trial is a double blind, placebo-controlled study of intranasal dexmedetomidine, Dex-IN, in the treatment of acute post-operative pain following bunionectomy surgery on Post Op Day 0. While analgesia and a reduction in opioid use were observed in a subset of patients, the study is not expected to reach statistical
significance in its current design. As a result, the Company plans to close this study and launch a revised study starting in Q4 2014. The Company will evaluate Dex-IN 50 mcg versus placebo in management of post-op pain starting Post Op Day 1 after bunionectomy surgery. Note that there were no serious adverse events observed in the REC-13-012 trial.

"There remains a significant unmet medical need for opioid-sparing analgesics, a need which we continue to believe may be addressed with Dex-IN," said Gerri Henwood, Recro Pharma's President and Chief Executive Officer. "Observations from an interim analysis of the REC-13-012 trial, however, suggest that the current study design will not allow us to reach statistical significance for single agent Dex-IN in a bunionectomy pain model starting on Post Op Day 0.
That said, analgesia and corresponding reduction in opioid use, observed in a subset of patients, suggest that Dex-IN may serve as an effective pain management tool in a Post Op Day 1 bunionectomy study model. Based on what we know about the trajectory of pain, together with these observations, which confirm our earlier trial results and demonstrate efficacy for the first time in acute post-op pain, we believe that a study of 50 mcg Dex-IN in a Post Op Day 1 setting is the best path forward."

The interim analysis was based on the primary endpoint, SPID48 (summed pain intensity difference over 48 hours). This preplanned interim analysis was designed to allow for possible sample size adjustment. The results of the interim analysis (n=68, approximately 22 patients per group) revealed that the efficacy of Dex-IN as a stand alone drug was not sufficient to manage severe pain in bunionectomy on post operative day zero, Post Op Day 0. As a result, increased sample size is unlikely to be an effective modification of the
trial.
In the interim analysis, the Company observed in patients with baseline pain intensity scores of ≤ 6 (N=34) that pain was more effectively managed on Post Op Day 0, as seen in the separation of scores between Dex-IN 50 mcg and Placebo (Table 1). In addition, based on an understanding of the trajectory of pain, it is recognized that pain on Post Op Day 0 is generally escalating, while pain on Post Op Day 1, or the day after surgery, is generally stable or declining. Based on the input from the Company's advisors, the results of the interim analysis and subset analyses, the information suggests that a post-operative pain management study in patients who initiate study treatment on Post Op Day 1 would be more effective than the current study design .



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OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, announced today that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols. Ipafricept is being studied in combination with standard-of-care in three Phase 1b studies.

"With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy," said Jakob Dupont, MD, OncoMed's Chief Medical Officer. "We appreciate the FDA's prompt response to our submission and their acceptance of our proposed amendments to the trial protocols."

OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA's Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

"We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. "The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development."

On June 13, 2014, OncoMed announced its decision to voluntarily halt enrollment in its Phase 1 vantictumab and ipafricept Wnt pathway programs as a precautionary measure based on reported incidents (13% and 5%, respectively) of mild-to-moderate bone adverse events. The FDA concurred with the company's decision and placed the studies on partial clinical hold, allowing for the continued dosing of patients who demonstrated benefit without significant drug-related adverse effects. The FDA removed the partial clinical hold on both programs based on data and amended study protocols submitted by OncoMed.



Also Thursday:


ActiveCare Inc. (OTCBB:ACAR)
, a leader in diabetes monitoring and wellness services for self-insured employers nationwide, previously announced in a published report a projection to add 17,000 new members between October 1, 2014 and June 30, 2015.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostic and therapeutic interventions for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, announced that Gerald E. Commissiong, President and CEO, is scheduled to present at the 14th Annual Biotech in Europe Forum at the Congress Center in Basel, Switzerland.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
, a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening viral respiratory infectious diseases, announced today that it will present a poster describing preclinical data on BTA-C585, the Company's oral fusion inhibitor in development for the treatment of respiratory syncytial virus infections (RSV), at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Meeting in Washington, DC.

Cellectar Biosciences, Inc. (Nasdaq:CLRB)
, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application to begin clinical study of I-131-CLR1404, a highly-selective, cancer-targeting radiopharmaceutical, in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, today announced that Matthew Plavan, Chief Executive Officer of Cesca, will present at the Rodman & Renshaw® Annual Global Investment Conference, being held at the New York Palace Hotel in New York.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals, today announced the appointment of W. Garrett Nichols, MD, MS as Chief Medical Officer, Essy Mozaffari, PharmD, MPH, MBA, as Vice President of Market Access and Reimbursement, and Odin Naderer, PharmD, as Vice President of Clinical Pharmacology and Translational Medicine.

CipherShop, a division of Cloud Medical Doctor Software Corporation (OTCQB:NSCT), announced today that CipherLoc® polymorphic cipher engine has completed Phase I development and is moving in to Phase II Silo development.

The Cooper Companies, Inc. (NYSE:COO)
today announced financial results for the fiscal third quarter ended July 31, 2014.

Egalet Corporation (Nasdaq:EGLT)
announces data presentations on Egalet-001, an abuse-deterrent, extended-release, oral morphine product candidate, at PAINWeek 2014 in Las Vegas September 2 to 6.

Emergent Health Corp. (Pink Sheets:EMGE)
announced in May 2014 it was in the process of placing a controlling interest to a shareholder group including Clover Capital Corp. and Parcae Capital Corp. The Company is pleased to announce that this control group now includes several other key people and the transaction was completed August 26, 2014.

GrowBLOX Sciences, Inc., aka GB Sciences (OTCQB:GBLX)
has expanded to the East Coast to make its brand of proprietary Cannabis-based medications available to patients in new markets.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today that Jeff Wolf, Chief Executive Officer, will be presenting a company overview at the Rodman & Renshaw 16th Annual Global Investment Conference being held September 8 - 10, 2014 at the New York Palace Hotel in New York and the Aegis Capital Healthcare and Technology Conference being held September 10 - 13, 2014 at the Encore at Wynn in Las Vegas.

Matinas BioPharma Holdings, Inc. (OTCBB:MTNB)
, an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, announced today that the Company will be presenting a corporate overview and a review of the development plans for its lead product candidate, MAT9001, at three upcoming investor conferences in September of 2014.

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced that the Company has engaged Jefferies LLC as its financial advisor to assist it in the development and evaluation of a full range of potential strategic alternatives for the Company.

Praxsyn Corporation (OTCQB:PAWS)
, today announced that its subsidiary, Mesa Pharmacy Inc., a medication and service provider for medical practitioners, is making progress towards its goal of dispensing its customized medications nationwide.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, today announced that Yossi Maimon, the Company's Chief Financial Officer, will present at the Rodman & Renshaw 16th Annual Global Investment Conference on Wednesday, September 10, 2014 at 1:15 PM, Eastern Time.

Recro Pharma, Inc. (Nasdaq:REPH)
, a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of pain, initially for acute pain following surgery, announced a clinical strategy update following findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the Company's REC-13-012 trial.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that Dror Ben-Asher, RedHill's Chief Executive Officer, will be presenting at the Rodman & Renshaw 16th Annual Global Investment Conference, on Wednesday, September 10, 2014, at 1:40 p.m. EDT, in the Holmes II Salon of the New York Palace Hotel in New York City.

StemCells, Inc. (Nasdaq:STEM)
announced today that management will present at the 16th Annual Rodman & Renshaw Global Investment Conference Wednesday, September 10, at 9:10 AM EDT in the Holmes II Salon room at the New York Palace Hotel, 455 Madison Avenue, New York, NY.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive™ Robotic Navigation System with V-Loop™ Variable Loop Catheter Manipulator in the U.S.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced that Daniel Swisher, Chief Executive Officer of Sunesis, will be presenting at the 2014 Morgan Stanley Global Healthcare Conference on Wednesday, September 10, 2014 at 9:10 AM Eastern Time at the Grand Hyatt New York in New York City.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
today announced interim results of a multi-center dry eye disease ("DED") prevalence study being carried out in the United Kingdom at four National Health Service ("NHS") hospitals.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Emil D. Kakkis, M.D., Ph.D., the company's Chief Executive Officer, will be presenting at the Morgan Stanley Global Healthcare Conference on September 10, 2014 at 12:55pm ET at the Grand Hyatt in New York.

VG Life Sciences, (OTC Pink: VGLS)
a biotechnology company, announces today an update to its physician-initiated IND phase I study to test safety and tolerability of its patented technology in patients with advanced stage solid tumors.

Vical Incorporated (Nasdaq:VICL)
today announced that the company will provide an overview of its technologies, development programs, and outlook on Wednesday, September 10, at 10:00 a.m. ET at the Rodman & Renshaw 16th Annual Global Investment Conference (New York, September 8 – 10).



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