OncoMed Begins Patient Dosing In Phase 2 Clinical Trial Of Tarextumab; MWV's MEMS System Chosen For Trials Of HIV-Prevention Medication Print E-mail
By Marilyn Mullen   
Monday, 01 December 2014 19:37
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 1, 2014.

OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED) 4.63%, announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "PINNACLE" clinical trial of its anti-Notch2/3 cancer stem cell antibody, tarextumab (OMP-59R5), for the treatment of small cell lung cancer (SCLC).

Tarextumab is being studied in combination with chemotherapy in patients with previously untreated, extensive stage SCLC. The randomized Phase 2 trial will compare progression-free survival (PFS) outcomes for patients treated with tarextumab administered at 15 mg/kg every two weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive chemotherapy alone. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. OncoMed scientists have determined that high tumor Notch3 expression is estimated to occur in about 60 percent of small cell lung cancer patients. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients.

"Small cell lung cancer is a devastating disease and patients are in need of new treatment options," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "Based on the manageable safety profile and the early response data observed in the Phase 1b portion of the PINNACLE study, we are excited to advance tarextumab into the randomized Phase 2 portion of this clinical trial. As reported in September at the 2014 ESMO Congress, tarextumab has been well tolerated and does not appear to add significant toxicities to standard-of-care chemotherapies. Additionally, partial responses were observed in 13 of 16 evaluable patients."

OncoMed has completed enrollment in the Phase 1b portion of the PINNACLE study, which was designed to establish a maximum-tolerated dose for tarextumab when administered in combination with etoposide and cisplatin or carboplatin. Phase 1b PINNACLE data in patients with small cell lung cancer was reported at the European Society of Medical Oncology (ESMO) Congress 2014 in September 2014. Tarextumab was well tolerated in combination with etoposide and cisplatin. Of sixteen patients evaluable for efficacy, thirteen achieved partial responses (81.3%) and the remaining three patients achieved stable disease for a clinical benefit rate of 100 percent.

"We are driving all of our pipeline programs toward advanced clinical read-outs and partner opt-ins," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "This is the second of four randomized Phase 2 programs expected to begin by late 2014 or early 2015. In addition to tarextumab in SCLC and pancreatic cancer, which are both now under way, we are very close to enrolling patients in randomized studies of our anti-DLL4 antibody, demcizumab, in pancreatic and non-small cell lung cancer. Our aim is to have multiple randomized Phase 2 data results between now and by the end of 2016."


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MeadWestvaco Corporation (NYSE: MWV)
has received a grant to provide its Medication Event Monitoring System (MEMS™) to The Bill & Melinda Gates Foundation. The system is being used in the foundation's new demonstration projects on pre-exposure prophylaxis (PrEP) medications to help prevent the spread of HIV/AIDS in sub-Saharan Africa and India. The four studies launched in October 2014.

Orally administered PrEP medications represent an important tool in the efforts to eradicate HIV/AIDS worldwide. These medications are given to high-risk but HIV-negative people, and have been shown to prevent transmission of the virus when people are adherent to their medication program1. MWV's MEMS System measures, monitors and improves adherence. It has previously been used in pivotal studies for HIV medications including Gilead's TRUVADA®, the first oral HIV medication the U.S. Food and Drug Administration approved for PrEP.

“PrEP medications are transforming the way we approach the global HIV/AIDS battle, offering a promise of protection against this deadly virus,” said Bernard Vrijens, PhD, chief science officer, MWV Healthcare. “However, this transformational intervention is only effective when people adhere to the prescribed dosing regimen. MWV Healthcare is grateful for the opportunity to join with the Gates Foundation in this important research, helping to understand and increase adherence to these life-changing medications.”

MWV Healthcare's system utilizes its MEMSCap™ smart electronic medication packaging. The system tracks each time the medication bottle is opened, a proven corollary for measuring when a pill is taken. These data are wirelessly transferred to MWV Healthcare's MedAmigo™ platform, a secure, web-based program for data analysis and modeling.

During the foundation's trials, MWV's scientific staff will analyze adherence data and provide trial coordinators with real-time feedback about each participant's adherence. When provided to participants, this real-time feedback at the point of care has been shown to be the most effective adherence intervention available2. In recent draft guidance, the FDA has recommended using smart medication packaging to measure and enhance adherence in clinical trials.3



Also Monday:





Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM)
, a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the US Food and Drug Administration (FDA) has granted orphan-drug designation for Actimab-A, an alpha radiolabeled antibody being developed for newly diagnosed AML in patients over the age of 60. Actimab-A is currently in a multicenter Phase 1/2 trial clinical trial.

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced that Pratik Shah, Ph.D., President and Chief Executive Officer, will present at the Piper Jaffray Healthcare Conference on Tuesday, December 2, 2014 at 9:50 a.m. EST at the New York Palace Hotel in New York City.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that it will present at the 26th Annual Piper Jaffray Healthcare Conference in New York on Tuesday, December 2, 2014.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX),
a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that Patrick J. McEnany, Chief Executive Officer, and Steven Miller, Ph.D., Chief Operating Officer and Chief Scientific Officer, will present at the Piper Jaffray 26th Annual Healthcare Conference held at The New York Palace Hotel in New York City, Dec. 2-3.

Galena Biopharma, Inc. (Nasdaq:GALE),
a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 1 clinical trials of GALE-401, or Anagrelide Controlled Release, will be presented at the upcoming 56th American Society of Hematology (ASH) Annual Meeting & Exposition.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that Jeff Wolf, CEO, will present a corporate update at the 26th Annual Piper Jaffray Healthcare Conference, taking place at the New York Palace Hotel, December 2-3, 2014.

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that at 8:35 AM ET on Thursday, December 11, 2014, Mr. Nissim Mashiach, Macrocure's President and Chief Executive Officer, will present at the Oppenheimer 25th Annual Healthcare Conference in New York City.

MedAssets (Nasdaq:MDAS) today announced a strategic partnership with Procured Health to deliver a holistic approach to implementing best-practice clinical value analysis programs. Under terms of the agreement, MedAssets will augment its industry-leading clinical value analysis consulting and services with Procured Health's proprietary data intelligence and collaboration technology platform.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
, a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib, the Company's novel oncology drug candidate, as a first-line treatment in combination with Abraxane® and gemcitabine in patients with metastatic pancreatic cancer. Momenta recently announced the successful completion of Part A of the Phase 1/2 study and has initiated the Part B (Phase 2 proof-of-concept) study.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
, a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International's biopharmaceutical business.

NeoStem, Inc. (Nasdaq:NBS)
, a biopharmaceutical company developing novel cell based therapies, announced today that the Company and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), will present at multiple upcoming conferences in December.

Neothetics, Inc. (Nasdaq:NEOT)
, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the closing of its initial public offering of 4,650,000 shares of its common stock at an initial public offering price of $14.00 per share.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced today that it has obtained an exclusive worldwide license from Austrianova Singapore Pte Ltd to use the unique and proprietary Cell-in-a-Box® cellulose-based live cell encapsulation technology in combination with compounds, known as cannabinoids, obtained from constituents of Cannabis for the development of disease treatments.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "PINNACLE" clinical trial of its anti-Notch2/3 cancer stem cell antibody, tarextumab (OMP-59R5), for the treatment of small cell lung cancer (SCLC).

Otonomy, Inc. (Nasdaq:OTIC)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that the company has achieved target enrollment in its Phase 2b clinical trial of OTO-104 in patients with Ménière's disease.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP)
today announced that on November 25, 2014, as a key requirement of the Company's strategy of strengthening its leadership team and employee base, continuing the expansion of its commercial activities into new territories, and increasing the expansion of its product development programs, the board of directors approved inducement stock option awards to new hire employees pursuant to the Raptor Pharmaceutical Corp. 2014 Employment Commencement Stock Incentive Plan.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company primarily focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced, together with IntelGenx Corp. (TSXV:IGX) (OTCQX:IGXT), a Canadian drug delivery company focused on oral drug delivery, that the German Federal Institute for Drugs and Medical Devices (BfArM) validated the Marketing Authorization Application (MAA) for RIZAPORT™, an oral thin film formulation of rizatriptan for acute migraines, and has initiated the formal review process of the application on November 25, 2014.

SANUWAVE Health, Inc. (OTCQB:SNWV)
today announced that the Company has enrolled its 130th patient in the Phase III supplemental clinical trial using dermaPACE® for treating diabetic foot ulcers (DFU's), which represents the number of patients the Company must enroll for the second interim analysis by the independent Data Monitoring Committee (DMC).

TG Therapeutics, Inc. (Nasdaq:TGTX)
announced today the initiation of a multi-center, Phase I trial to evaluate the safety and efficacy of the combination of TGR-1202 and ibrutinib for patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

uniQure N.V. (Nasdaq:QURE)
, a leader in human gene therapy, today announced results for the third quarter of 2014.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Turnpike catheters, a new line of catheters designed for use in complex coronary and peripheral interventions.

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced the publication of a long-term Phase 3 open-label study, which showed that Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, were generally safe, well-tolerated and effective in treating chronic pain for up to one year.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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