Arena Reports Closing of Phase 1b Clinical Trial for APD811; Astex Shares On Watch Following Positive Top-Line Data for SGI-0110 Print E-mail
By Staff and Wire Reports   
Thursday, 29 August 2013 18:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 29, 2013.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announced the completion of a Phase 1b clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a Phase 2 clinical trial for APD811 in the first quarter of 2014.

"Arena's internal GPCR-focused efforts led to the discovery of this novel drug candidate," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We believe APD811 is a promising new chemical entity that could improve current patient care by providing an oral option for IP-targeted therapy. Based on the encouraging Phase 1 results, we look forward to initiating the Phase 2 program early next year."

This randomized, double-blind and placebo-controlled Phase 1b clinical trial evaluated the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD811. Arena previously evaluated single-ascending doses of APD811 in a Phase 1a clinical trial.

In the Phase 1b clinical trial, 40 healthy volunteers received APD811 and 15 received placebo, and the safety profile of APD811 was characteristic of IP receptor agonists. No serious adverse events were observed, and the most frequent treatment-emergent adverse events were headache, nausea and jaw pain. The results of the Phase 1 program led to the decision to proceed with Phase 2 development of APD811, which will include further exploration of dosing regimens in PAH patients.


Astex Pharmaceuticals, Inc. (Nasdaq: ASTX)
announced top-line results from the ongoing phase 2 of SGI-110 in patients with AML and MDS. The Phase 2 study is a randomized study of SGI-110 given either as 60 or 90 mg/m2 daily for 5 days in a 28-day course. As of end of June data cutoff, 67 AML patients had a minimum follow up of 3 months (50 patients representing the complete cohort of relapsed/refractory AML, and 17 patients in the treatment-naive elderly AML not suitable for induction chemotherapy cohort).

The primary endpoint is overall remission rate (Complete Remission or CR; Complete Remission with Incomplete hematologic recovery or CRi/CRp). There were 8 remissions in relapsed/refractory AML and 9 remissions in treatment-naive elderly AML for an overall complete remission rate (CR, CRi/CRp) of 17/67 or 25%. The detailed results have been submitted for presentation to the American Society of Hematology (ASH) meeting to be held later this year during December 7-10 in New Orleans, LA.

Also Thursday:

Apricus Biosciences, Inc. (Nasdaq:APRI)
, today announced that Swissmedic, the Agency for Therapeutic Products in Switzerland, has recommended against approval of marketing authorization for Vitaros® for the treatment of erectile dysfunction ("ED") based on certain quality related issues.

Aratana Therapeutics (Nasdaq: PETX)
, a development-stage biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets (pet therapeutics), today announced that it will host a Pet Therapeutics Primer and Product Update Event, to be held September 11, 2013, at the Four Seasons Hotel in Boston.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's first and largest private online health insurance exchange, is offering Medicare Advantage plans and Medicare Prescription Drug Plans (PDPs) from WellCare Health Plans, Inc. on its online marketplaces and now also through telephonic enrollment.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's first and largest private online health insurance exchange, announced today that it has added new supply of Medicare Advantage plans from Cigna-HealthSpring to its selection of Medicare products.

Eternity Healthcare Inc. (OTCQB: ETAH)
,a biopharmaceutical company with technologies in drug delivery, specialty pharmaceuticals and medical devices, announced today that it has completed a financing in the amount of $1,362,434 for issuance of 2,724,868 Common Shares to international investors.

is pleased to announce that its wholly owned subsidiary HPIL ENERGYTECH Inc., on August 26, 2013, entered into a Cooperation Agreement with O.R.C. SRL, a private company focused on investing in the energy sector.

Humana Inc. (NYSE: HUM)
, one of the nation's leading health and well-being companies, and Eli Lilly and Company (NYSE: LLY), a leading, innovation-driven corporation, today announced a joint research collaboration aimed at improving the health care of their members and patients.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA)
today announced that it has entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Cancer Institute (NCI) to evaluate the Company’s Toll-like receptor (TLR) antagonists as a potential approach to the treatment of certain genetically defined B-cell lymphomas.

Integra LifeSciences Holdings Corporation (Nasdaq: IART)
announced today that it will present at the following conferences in the next few weeks:  At 11:10 AM ET on Wednesday, September 11, 2013, Mr. Jack Henneman will present at the 2013 Morgan Stanley Global Healthcare Conference in New York, NY.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), during today's special meeting of shareholders of Medicago (the "Meeting"), is pleased to annouce that its shareholders have approved the resolution authorizing the previously announced plan of arrangement involving the Company, Mitsubishi Tanabe Pharma Corporation (the "MTPC") and 9284-9686 Québec Inc., a wholly-owned subsidiary of MTPC.

Medifocus, Inc. (OTCQX: MDFZF), (TSX VENTURE: MFS)
, a leader in the use of focused microwave energy to treat cancer and other tumors, is pleased to announce its financial results for its first fiscal quarter of 2014 ended June 30, 2013.

MGC Diagnostics Corporation (NASDAQ: MGCD)
, a global medical technology company, today reported financial results for the third quarter ended July 31, 2013.

Milestone Scientific Inc. (OTCQB: MLSS)
, the recognized leader in advanced, computer-controlled injection technologies, today announced a distribution agreement with Henry Schein, Inc., the world's largest provider of health care products and services to medical, dental, and veterinary office-based practitioners.

MWI Veterinary Supply, Inc. (NASDAQ: MWIV)
announced today that it has entered into a definitive agreement to acquire substantially all of the assets of IVESCO Holdings LLC for an enterprise value of $67.5 million.

Novadaq® Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ)
, a developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures, today announced that Dr. Arun Menawat, the company's President and Chief Executive Officer, will present Novadaq's corporate overview at the Stifel Healthcare Conference 2013.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
today announced that the second Phase III pivotal trial to evaluate elagolix for the treatment of endometriosis has been initiated by AbbVie.

Nutra Pharma Corporation (OTCQB:NPHC)
, a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that New Vitality, a marketing and distribution company, has placed and received their first order of the Company's all-natural, non-addictive pain reliever, Nyloxin®.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
today announced initiation of the Rainier™ clinical trial, an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen (OGX-427) in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine in patients with previously untreated metastatic pancreatic cancer.

ONMED Corporation (NASDAQ: CNMD)
, a medical technology company specializing in medical devices for orthopedic and general surgery, announced today that the Company will participate in CL King's 11th Annual Best Ideas Conference 2013 on Thursday, September 12, 2013 at 10:40 AM Eastern Time.

OPKO Health, Inc. (NYSE: OPK) and PROLOR Biotech, Inc. (NYSE MKT: PBTH) jointly announced today the completion of the acquisition of PROLOR by OPKO.

PuraMed BioScience®, Inc., (OTCBB:PMBS)
, a researcher, developer, and marketer of over-the-counter (OTC) medicinal and healthcare products, announced that it will discuss LipiGesic M on Armed Forces Network.

Pharmacyclics, Inc. (Nasdaq: PCYC)
today announced that the U.S. Food and Drug Administration (FDA)  has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
, announced today that it will present at the Rodman and Renshaw 2013 Annual Global Investment Conference in New York City from September 8th to 10th, 2013.

ThermoGenesis Corp. (Nasdaq: KOOL)
, a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today reported financial results for the fourth quarter and year-ended fiscal 2013.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health care delivery system, today announced certain preliminary information regarding the quarter ended June 30, 2013.

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