|Nymox Issues Results on NX02-0018 Phase Trial; OncoMed Granted Patent for Methods of Treating Cancer|
|By Staff and Wire Reports|
|Thursday, 22 August 2013 19:18|
Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the most recent Safety Monitoring Committee periodic review of safety data for the Company's NX02-0018 clinical trial, one of the two Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The August 20, 2013 Safety Monitoring Committee meeting found no significant safety concerns to date. Both of the Company's pivotal Phase 3 trials have completed enrollment and treatment (a single intraprostatic injection of either drug or placebo) and patient evaluation is continuing at over 70 well-known urology investigative sites across the U.S.
NX-1207 for the treatment of BPH is in Phase 3 development in the U.S. and in the EU under the sponsor of the Company's European licensing partner, Recordati S.p.A. NX-1207 is a first-in-class therapeutic that is administered directly into the prostate by a urologist in an office setting. The procedure does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. NX-1207 has thus far shown none of the adverse sexual side effects associated with approved medical and surgical treatments for BPH.
Previous clinical trials found that a single administration of NX-1207 2.5 mg produced on average improvements in the standardized BPH symptom score (8-10 points at 90 days) that were approximately double that reported for currently approved BPH drugs (3-5 points) without the sexual, blood pressure, or other side effects associated with the approved drugs. Follow-up studies have shown durable clinically significant benefit for up to 7 ½ years after a single treatment.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.
OncoMed Pharmaceuticals (Nasdaq: OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,507,442 to OncoMed for methods of treating cancer with its antibody vantictumab (OMP-18R5). Vantictumab targets and inhibits the Wnt pathway, which is believed to be an important CSC pathway. The patent expires in 2029.
Vantictumab was originally identified at OncoMed from the HuCAL GOLD® antibody library (MorphoSys AG) by binding to the Frizzled-7 receptor and was later determined by OncoMed to bind a novel epitope conserved across five different Frizzled receptors. Vantictumab has demonstrated broad anti-CSC and anti-tumor activity in patient-derived xenograft models and is currently being evaluated in a Phase 1 clinical trial where it has provided early signs of single-agent activity in patients with neuroendocrine tumors. The antibody is part of OncoMed's collaboration with Bayer Pharma AG.
OncoMed previously received a U.S. patent claiming the composition of matter for vantictumab and has corresponding patents or pending patent applications covering vantictumab in fourteen additional countries and Europe. In addition, OncoMed has a robust patent portfolio of over 300 patents or pending patent applications, which includes multiple additional patent families related to vantictumab or its use.
"OncoMed's new patent, together with its composition-of-matter patent, provides key patent coverage for vantictumab," said Paul Hastings, Chief Executive Officer of OncoMed. "The issuance of this patent also further validates the novelty of this promising antibody and the innovative nature of OncoMed's ongoing discovery programs, which have not only produced vantictumab, but also four other anti-CSC agents currently in clinical trials."
Astro-Med, Inc. (NASDAQ: ALOT), a manufacturer of specialty high tech printing systems and data acquisition systems, will announce its financial results for the Second Quarter ended August 3, 2013 on Thursday, August 29, 2013 at 4:00 pm Eastern Daylight Time.
Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company™, will visit the NASDAQ MarketSite in Times Square to celebrate its listing on the NASDAQ Stock Market, which occurred on November 8, 2012.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that it has reached an historic social media milestone, by exceeding 100,000 fans who have "Liked" its Facebook page at www.facebook.com/biolaseinc.
Burcon NutraScience Corporation (TSX: BU) (NASDAQ: BUR), a leader in developing functionally and nutritionally valuable plant-based proteins, has been invited to present at the 2013 Gateway Conference being held on Tuesday, September 10, 2013 at the Palace Hotelin San Francisco.
Cellular Biomedicine Group (OTCQB: CBMG) today announced that it has completed patient enrollment for its Phase I trial to evaluate the safety and preliminary efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.
Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) (OTCQX:CYNAF), a specialty pharmaceutical company developing the only oral (sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease, today announced its results for the six months ended June 30, 2013.
Digirad Corporation (NASDAQ: DRAD), the leader in solid-state diagnostic imaging technology and services, and Dilon Diagnostics, the world leader in molecular breast imaging, today announced that they have signed an exclusive international distribution agreement for Dilon to distribute Digirad's lines of nuclear imaging cameras including the ergo™, a large field-of-view general purpose imaging system, the Cardius® x.act, a triple-head cardiac dedicated SPECT imaging system with VCT Attenuation Correction, and the Cardius® XPO dedicated cardiac SPECT imaging systems line.
GreeneStone Healthcare Corporation (OTCBB:GRST), a provider of healthcare services and operator of several mental health clinics, has agreed to acquire the operations of the Castelli Clinic (the "Clinic"), an endoscopy and gastroenterology practice located in downtown Toronto.
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) today announced it has received a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") requesting authorization to manufacture and market generic versions of Forfivo XL™ ("Forfivo") 450 mg capsules in the United States.
Luminex Corporation (NASDAQ: LMNX) announced today that management will present at the Morgan Stanley Global Healthcare Conference to be held September 9 -11, 2013 in New York, NY.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) announces its intent to close a private placement of up to 11,428,572 units (the "Units") to raise gross proceeds of up to US$12,000,000 (the "Private Placement").
TheDirectory.com, Inc. (PINKSHEETS: SEEK), an emerging leader in the Local search space, today released the following update to its shareholders.
The Spectranetics Corporation (Nasdaq:SPNC), a leading maker of medical devices used in minimally invasive cardiovascular procedures, today announced the appointment of Kimberly McIntosh Bridges as Senior Vice President, Sales and Marketing, Vascular Intervention, effective August 30, 2013.
TelVue® Corporation (PINKSHEETS: TEVE), the innovation leader in Television and Internet Broadcasting for communities, cable operators, and media companies today expanded the versatility of its recently-unveiled TelVue Connect Media Exchange, by giving broadcasters the option of setting up their own private video-sharing groups.
Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today it will be participating in the Morgan Stanley 2013 Health Care Conference on Monday, September 9.
Vical Incorporated (Nasdaq:VICL) today announced a restructuring to conserve capital, including a staff reduction of 47 employees, approximately 39% of the company's total workforce. Following the restructuring, the company will have approximately 74 employees.