|PlasmaTech Announces Initiation of Enrollment of MuGard® Trial for Afinitor®; Ironwood Initiates Phase I Clinical Study of IW-1973|
|By Mary Davila|
|Thursday, 05 March 2015 20:08|
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 onhttp://clinicaltrials.gov, 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.
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