AzurRx BioPharma, Inc. (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, that the first three patients in the Phase IIa clinical trial with MS1819-SD for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) have been enrolled.
The open-label, dose escalation Phase II study is being conducted in two sites in Australia, The Royal Adelaide Hospital and Linear Clinical Research in Perth, as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch. The study is projected to complete 12-15 patients with EPI caused by chronic pancreatitis over the next several months. Read this and more news for AZRX at http://marketnewsupdates.com/news/azrx.html
The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with CP. The secondary objective is to investigate the efficacy dose response of MS1819-SD in these patients by analysis of the coefficient of fat absorption (CFA) and its change from baseline. Safety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests. The Company anticipates reporting data periodically during this trial, with results from the first group of patients enrolled expected to be reported in the first half of 2017.
In other Biotech/Pharma developments of note in the markets this week:
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of cancer, recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted full approval to Erivedge® (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. Erivedge is also approved in the U.S. for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) this week announced it has entered into an exclusive option, collaboration and license agreement for the global development and commercialization of its first-in-class, orally active pan-caspase inhibitor emricasan with Novartis. Under the terms of the agreement with Novartis, Conatus will receive $50 million upfront, and is eligible to receive $7 million following the exercise of the license option. Conatus can borrow up to $15 million in the form of convertible promissory notes under an investment agreement with Novartis.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), a rare cancer-focused innovative biotechnology company, this month announced clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in ALK-positive (ALK+) non-small cell lung cancer (NSCLC) patients who had experienced disease progression on crizotinib therapy. As of May 31, 2016, the data show that of patients on the 180-mg regimen with a median follow-up of 11 months, 55 percent achieved confirmed objective response as assessed by the investigator. In this arm, the median progression-free survival (PFS) was 15.6 months in this post-crizotinib setting, by both investigator and independent review committee (IRC) assessment. Additionally, in this arm, 67 percent of patients with measurable brain metastases achieved a confirmed intracranial objective response, and intracranial PFS was 18.4 months among patients with any brain metastases at baseline.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) yesterday announced positive top-line results from its Phase II exploratory study (-019 Study) of pimavanserin in patients with Alzheimer's disease psychosis (AD Psychosis). As a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, pimavanserin has a different biological mechanism than other marketed antipsychotics. Pimavanserin has been approved by the United States Food and Drug Administration (FDA) for hallucinations and delusions associated with Parkinson's disease psychosis and currently is being studied in several other disease states, including AD Psychosis. The FDA has not approved any drug to treat AD Psychosis.
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