|Ocera Completes Interim Analysis of OCR-002 in Phase 2b STOP-HE Study; Nymox Announces Phase 3 BPH Studies|
|By Marilyn Mullen|
|Wednesday, 01 April 2015 21:10|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 1, 2015.
Ocera Therapeutics, Inc. (NASDAQ: OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced successful completion of a planned interim analysis of its STOP-HE study, a double-blind placebo-controlled study of OCR-002 in patients with acute hepatic encephalopathy (HE). The study's independent Data Monitoring Committee (DMC) reported that the trial is not futile and no drug-related safety signals have been observed in the study. Based on the DMC's recommendation, Ocera will continue the STOP-HE study and will increase target enrollment from 140 patients to approximately 230 patients. The Company remains blinded to data reviewed by the DMC in the interim analysis.
"We are encouraged that these early data suggest a promising treatment effect with OCR-002 and a reduction in time to recovery for patients with acute hepatic encephalopathy," said Linda S. Grais, M.D., Chief Executive Officer of Ocera. "While the new enrollment target will extend our timelines, we believe that this will enhance the likelihood of achieving a positive result at the end of the study. Treatment options for these severely ill patients are sub-optimal. We believe OCR-002 may help these patients recover more rapidly from acute episodes of HE, as well as provide pharmacoeconomic benefit to hospitals, payors and the healthcare system. With the new enrollment target, we anticipate completing this trial in the second half of 2016."
HE is a serious, rare, progressive and episodic complication of liver cirrhosis, or liver failure, marked by mental changes including confusion, impaired motor skills, disorientation in time and space, and in its more severe form, stupor, coma and even death.
"This positive recommendation is important for the advancement of newer therapies for seriously ill HE patients who are not responding to current standard of care," commented Jasmohan Bajaj, M.D. Dr. Bajaj, a STOP-HE study investigator, is a gastroenterologist and transplant hepatologist at Virginia Commonwealth University and the McGuire Veterans Affairs Medical Center in Richmond, Virginia. "HE in the acute care setting remains a challenging clinical condition. OCR-002 is a novel, promising therapeutic option for HE and we look forward to the speedy completion of this trial."
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced the Company is undertaking further analyses of its pivotal U.S. Phase 3 studies of NX-1207 for prostate enlargement (BPH). This will include new long-term data from Studies NX02-0017 and NX02-0018. The Company expects to provide these new pivotal Phase 3 study results in Q2 or early Q3 this year.
The pivotal U.S. studies NX02-0017 and NX02-0018 were initiated in 2009. Enrollment of NX02-0017 (499 patients randomized) was completed in 2012; enrollment of NX02-0018 (498 patients randomized) was completed in 2013. 973 patients were injected with either NX-1207 2.5 mg (n=582) or saline vehicle alone as control (n=391). At 12 months post-treatment there was no overall top-line statistical significance for the efficacy of treatment in terms of BPH Symptom Score improvement vs controls. The safety profile of NX-1207 was excellent.
Dr. Paul Averback, CEO of Nymox said, "Despite the setback of top-line results not initially beating controls statistically at 12 months post-treatment in these large studies, we continue to believe that NX-1207 has enormous potential for long-term management of BPH. Additional new blinded protocol data from the same pivotal studies is being prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo."
NX-1207 is also in late-stage development for low grade localized prostate cancer. In 2014 the Company reported 8 month efficacy results showing statistically significant reduced cancer progression in patients who received NX-1207 compared to standard of care.
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, today announced that Claire M. Gulmi, Chief Financial Officer of AmSurg Corp., has been elected to the Air Methods' board of directors.
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced new management appointments which expand the company's ability to engage with external partners and stakeholders. Linda Lennox has joined the company as vice president of investor relations & corporate communications, assuming responsibilities from Kathryn Carr Payne who has been promoted to vice president of external affairs. In this newly established role for AMAG, Ms. Payne will direct the company's public affairs activities, which includes leading AMAG's public relations, policy and advocacy initiatives at the state and national level.
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 based on the Arcelis® technology platform, today announced that the NIH Division of AIDS (DAIDS) has approved $6.6 million in funding for an investigator-initiated Phase 2a adult eradication study of AGS-004, the company's investigational fully personalized immunotherapy for HIV.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, today announced that it has executed an agreement with America's Choice Provider Network® (ACPN®), an independent national network of healthcare providers in the US that offers out-of-network solutions for over 1100 payers.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering.
Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the appointment of Eric H. Bjerkholt to the Company's Board of Directors and as Chair of the Board's Audit Committee.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and year ended December 31, 2014, and provided an update on recent strategic developments.
ERBA Diagnostics, Inc. (NYSE MKT:ERB), a fully integrated in vitro diagnostics company, announced that it is delaying the filing of its Annual Report on Form 10-K for the year ended December 31, 2014 with the Securities and Exchange Commission (the "SEC").
Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing its proprietary topical foams to address unmet needs in dermatology, today announced it has filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed public offering of its ordinary shares. All of the shares will be offered by the company.
Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for oncology and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, for the treatment of diffuse large B-cell lymphoma (DLBCL).
INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, is ranked "Top CRO to Work With" among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the filing of an initial Form 10 Registration Statement with the Securities and Exchange Commission ("SEC") in connection with its previously announced plan to spin off SeaSpine Holdings Corporation. SeaSpine, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, has a comprehensive portfolio of orthobiologics and spinal fusion hardware.
Interleukin Genetics, Inc. (OTCQB:ILIU) today announced two late-breaking poster presentations supporting its Inherent Health® Weight Management Genetic Test at the 2015 Experimental Biology Annual Meeting taking place March 28 – April 1, 2015, in Boston.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the appointment of Mikael Dolsten, MD, PhD, President of Pfizer Worldwide Research and Development of Pfizer Inc., to the company's board of directors.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced its spring educational webinar series to be delivered by Laila Qasim Esq., Client Advocate and Associate General Counsel.
Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced successful completion of a planned interim analysis of its STOP-HE study, a double-blind placebo-controlled study of OCR-002 in patients with acute hepatic encephalopathy (HE).
Pazoo, Inc. (OTC Pinks:PZOO) (German WKN#: A1J3DK) is proud to announce that wholly owned subsidiary, Harris Lee, LLC, has entered into a Binding Letter of Intent with Front Range, the Steep Hill licensee for Colorado, to purchase the assets to operate Steep Hill Colorado, a marijuana testing laboratory located in Denver, CO.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®, has been accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. This investigational product, which is the Company's lead product candidate, is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound.
ScripsAmerica Inc. (OTCBB:SCRC), today announced the appointment of Austin Lewis to the Company's Board of Directors.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) today announced the closing of its underwritten public offering of 7,000,000 shares of common stock at a price of $33.25 per share by certain existing stockholders of SCA (the "Selling Stockholders"), including certain affiliates of TPG Global, LLC and certain directors and officers of SCA.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today gevokizumab will be tested in a Phase 2 study in patients with Type 2 diabetes and diabetic kidney disease, clinically referred to as diabetic nephropathy.