PlasmaTech Announces Initiation of Enrollment of MuGard® Trial for Afinitor®; Ironwood Initiates Phase I Clinical Study of IW-1973 Print E-mail
By Mary Davila   
Thursday, 05 March 2015 20:08
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 5, 2015.

PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI)
, announced enrollment has begun in a clinical trial at UCLA's Jonsson Comprehensive Cancer Center that is evaluating MuGard in the prevention and treatment of stomatitis in breast cancer patients using everolimus (marketed by Novartis Oncology under the trade name Afinitor®).

The title of the trial is "Phase II Randomized Trial of MuGard Compared with Best Supportive Care for Prevention and Treatment of Stomatitis in Women With Hormone Receptor Positive Breast Cancer Initiating Treatment With Everolimus-based Endocrine Therapy" and details on the trial design and enrollment can be found on, under the identifier NCT02015559.

Commenting on the trial, David Nowotnik, Ph.D., PlasmaTech's Senior Vice President, Research and Development stated, "The Company is pleased to see that the clinical community continues to evaluate usage, and expand the body of clinical evidence, that supports the use of MuGard in the treatment of patients experiencing the debilitating side effect of oral mucositis and stomatitis. The Company believes that the incidence of oral mucositis, and the problems it causes for patients and patient compliance, continues to grow as important new therapies such as everolimus expand commercially. MuGard offers clinicians an important option in the management of this challenging side effect."




Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
announced dosing has begun in a Phase I clinical study of IW-1973, the first clinical compound in a broad, pharmacologically-differentiated library of soluble guanylate cyclase (sGC) stimulators discovered by Ironwood. Data are expected in the second half of 2015. Ironwood expects to advance a second sGC stimulator, IW-1701, into a Phase I clinical study later this year.

“We look forward to exploring the potential of sGC stimulators across multiple, select therapeutic opportunities within a broad potential range that may span cardiovascular diseases, fibrosis, muscular dystrophy, glaucoma, dementia and diabetic complications,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “It is rare in drug discovery to have the opportunity to modulate one of the fundamental regulators in the human body, and we are fortunate to have the pharmacologic expertise to advance what we believe can be strongly differentiated molecules in this space.”

The randomized, double-blind, placebo-controlled Phase I clinical study is designed to assess the safety, pharmacokinetic profile and pharmacodynamic effects of IW-1973 in healthy volunteers.

The IW-1973 Phase I study is the seventh clinical study ongoing in Ironwood’s research and development pipeline this year. Other clinical studies conducted by Ironwood include an ongoing Phase IIa clinical study of IW-9179 in diabetic gastroparesis and a recently completed Phase IIa clinical study of IW-3718 for refractory gastroesophageal reflux disease. Clinical studies ongoing with partners include Phase III trials with linaclotide for adults with irritable bowel syndrome with constipation for China and for Japan, as well as a Phase III trial with a 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation and a Phase II clinical study of linaclotide for adults with opioid-induced constipation, both in the U.S.


Also Thursday:

Amedica Corporation (Nasdaq:AMDA)
, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced financial results for the fourth quarter and full year ended December 31, 2014.

Anavex Life Sciences Corp. (OTCQX:AVXL)
, a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced the appointment of Corinne Lasmézas, DVM, PhD, to the Company's Scientific Advisory Board. A Professor at The Scripps Research Institute for the past 10 years and multiple TED speaker, Dr. Lasmézas is an internationally recognized expert in the field of neurodegenerative diseases with a focus now on studying the mechanisms of neurodegeneration.

Avalanche Biotechnologies, Inc. (Nasdaq:AAVL)
, a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today reported financial results for the fourth quarter and year ended December 31, 2014.

AXIM Biotechnologies, Inc. (OTC:AXIM)
proudly presented its line of the world's first oral care and cosmetic products that include cannabigerol (CBG) during a recent news conference.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in Circulating Tumor Cells (CTCs) and Circulating Tumor DNA (ctDNA) biomarker analysis, today announced that Jason Poole, Ph.D. has joined the Company as Senior Director, Molecular Assay Development.

Bio-Reference Laboratories, Inc. (Nasdaq:BRLI) announces first quarter results. Except for per share data or where otherwise noted, numbers are in thousands.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it is currently enrolling a Phase II clinical trial with Cenderitide, a dual receptor natriuretic peptide agonist that has previously been used in approximately 270 patients including those suffering from acute decompensated heart failure.

Calithera Biosciences, Inc. (Nasdaq:CALA),
a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today an exclusive global license agreement with TransTech Pharma, a clinical stage pharmaceutical company, granting Calithera exclusive world-wide rights to research, develop and commercialize TransTech's portfolio of hexokinase II inhibitors.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, a developer and producer of fully functioning human cells in industrial quantities to precise specifications, today reported financial results for the fourth quarter and for the fiscal year ended December 31, 2014.

The Cooper Companies, Inc. (NYSE:COO)
today announced financial results for the fiscal first quarter ended January 31, 2015.

Fibrocell Science, Inc. (Nasdaq:FCSC)
, an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that it will report fourth quarter and full year 2014 financial and operating results on March 13, 2015.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Julie Hambleton, M.D., Chief Medical Officer, will present at the Barclays Global Healthcare Conference on Thursday, March 12, 2015 at 1:05 PM Eastern Daylight Time.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today reported its financial results for the quarter and year ended December 31, 2014 and provided a business update.

Inovio Pharmaceuticals, Inc. (Nasdaq:INO)
, a leader in the development of immunotherapies for cancer and infectious diseases, announced today that Nancy Wysenski joined its Board of Directors.

Islet Sciences, Inc. (OTCQB:ISLT)
, a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today a Notice of Claims Allowance for the U.S. Patent Application No. 12/511,654 entitled "Progression inhibitor for disease attributed to abnormal accumulation of liver fat" (Patent number: US8,951,976).
Prothena Corporation plc (Nasdaq:PRTA)
, a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today reported financial results for the fourth quarter and full year ended December 31, 2014 and provided 2015 financial guidance and an update on its lead programs.

ScripsAmerica Inc. (OTCBB:SCRC)
, today announced that the Company's Florida-based pharmaceutical distributor, PIMD International LLC, reported $554,411 in revenue during the month of February 2015.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR)
, a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic hepatitis B infection (HBV), announced that it will hold a conference call and webcast on Thursday, March 12, 2015 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) to provide a corporate update and report on its financial results for the fourth quarter and year ended December 31, 2014.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced today the results from its Phase 1 first-in-human study of XOMA 358, an allosteric modulating monoclonal antibody that binds to insulin receptors and attenuates insulin action, will be presented at the Endocrine Society's 97th Annual Meeting, taking place from March 5-8, 2015, in San Diego, California.

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