PSDV
ALIM
RVX.TO
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX - News) announces that the Company's Phase 2 clinical trial, called ASSURE (ApoA-1 Synthesis Stimulation in Acute Coronary Syndrome patients), has made important modifications to the design of the trial which have the potential to demonstrate a more powerful endpoint for the planning of future clinical trials for RVX-208.
Key changes to this clinical trial include: - Raising the number of patients to be recruited from 120 to over 230. - All patients will now undergo an intravascular ultrasound (IVUS) assessment versus the previously planned 60 patients. - Trial sites increase from 20 to approximately 45. - Clinical trials will be conducted in multiple countries to accelerate recruitment. - The study will include patients with low HDL. - Primary endpoint is now plaque regression.
Donald J. McCaffrey, President & CEO of Resverlogix noted, "The most important take away message is that by moving the end point to atherosclerosis regression this will provide a more robust proof of concept. Achieving plaque regression could potentially reduce the development time for RVX-208 by two years."
IRWD
announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation.
Results from a second Phase 3 trial of linaclotide is expected in the fourth quarter.
ALXA
With an FDA decision due in early October, Alexza Pharmaceuticals' (ALXA) stock has been reacting very nicely in anticipation, making a string of higher highs and higher lows since early August.
"The data we have seen from the Staccato loxapine trials are compelling," said Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX. "The product exhibits a rapid and predictable reduction in agitation, and appears to have a favorable safety profile in these patient populations."
seekingalpha.com
BIOD --> GNBT
Linjeta is a more rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. Linjeta provides quicker glucose control than standard insulin, and also touts the benefits of reducing the usual weight gain and life-threatening hypoglycemic events seen in insulin users. Current insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike. The formulation of insulin in Linjeta promotes a more rapid absorption, which more closely mirrors the effects of naturally produced insulin in non-diabetics, thereby providing more effective blood glucose control
seekingalpha.com
DARA
DARA Announces Analytical Results in Efficacy and Dose Response of KRN5500 in Patients with Chemotherapy Induced Peripheral Neuropathy and Advanced Cancer
finance.yahoo.com
BSDM
BSD Medical Reports Receipt of Safety Certification for MicroThermX Microwave Ablation System
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radio frequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system, which the Company will introduce to the market this year, has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue.
ALNY
Alnylam Pharmaceuticals (Nasdaq: ALNY) and Cubist Pharmaceuticals (Nasdaq: CBST) are working on a treatment for RSV -- Synagis and motavizumab are just prophylactics that prevent infection -- but it's still in phase 2 development, so AstraZeneca can enjoy its Synagis sales for a while.
“We are excited by the research being presented at this meeting, which together illustrate the very significant progress Alnylam scientists are making in the discovery and development of RNAi therapeutics. Certainly, these cumulative data demonstrate Alnylam’s continued scientific leadership in the advancement of RNAi therapeutics as a new class of innovative medicines,” said Muthiah Manoharan, Ph.D., Senior Vice President, Drug Discovery. “Some notable highlights from our presentations include results showing superior properties of canonical siRNAs compared with so-called ‘dicer substrate’ constructs, the application of ‘click chemistry’ approaches to the synthesis of siRNA conjugates, and the synthesis of novel cationic lipids for systemic delivery of siRNAs with lipid nanoparticles.”
XNPT
Shares of XenoPort Inc. /quotes/comstock/15*!xnpt/quotes/nls/xnpt (XNPT 6.90, -0.14, -1.96%) rallied early Monday after the biotech group said it plans to advance its drug candidate arbaclofen placarbil, also known as XP19986, into Phase III testing.
The compound is being tested for the treatment of spasticity in multiple sclerosis patients.
XenoPort shares were up 9% at $6.76. The drug sector's two key indexes also moved higher in early action. The
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