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Salix Pharmaceuticals (Nasdaq: SLXP) $24.25. Today announced that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
“We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years,” stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. “We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today’s independent recommendation from the outside experts comprising the advisory committee reinforces the Company’s confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition.”
The committee reviewed data from the Company’s 299-subject, double-blind, placebo-controlled, multinational, Phase 3 study. This study demonstrated a statistically significant and clinically meaningful reduction in the risk of recurrent overt HE.1 The primary endpoint – the risk of experiencing a breakthrough overt HE episode – was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p<0.0001). The key secondary endpoint – risk of experiencing HE-related hospitalization – was reduced by 50 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p=0.0129). The committee also reviewed supporting evidence from the Company’s long-term, open-label, Phase 3 study, as well as evidence derived from clinical studies in acute HE, three-month and six-month studies from the published literature and meta-analyses.
What They Do: Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
Vical Incorporated (Nasdaq: VICL) $3.31. Today announced today the publication in the online edition of Vaccine1 detailed data from two Phase 1 trials of the company's Vaxfectin-adjuvanted DNA vaccines for H5N1 (avian-origin) influenza, demonstrating the potential of DNA vaccines for rapid deployment in future pandemics.
"Our Phase 1 results clearly demonstrated the ability of DNA vaccines against H5N1 avian-origin influenza to achieve antibody responses in the same range as conventional vaccines," said Larry Smith, Ph.D., Vical's Vice President of Vaccine Research and the lead author on the paper. "These trials are key to expanding the use of our Vaxfectin adjuvant as they provided its first successful safety evaluations in humans. We seized the opportunity to further demonstrate the potential of our technology during the 2009 H1N1 pandemic influenza outbreaks. We completed successful pilot lot production and initiated animal immunogenicity testing of a Vaxfectin-adjuvanted DNA vaccine for H1N1 pandemic influenza before conventional vaccine manufacturers even received the seed virus needed to start production. We published these data in late 2009, and expect to begin a U.S. government-funded Phase 1 clinical trial of our H1 pandemic influenza vaccine soon."
The double-blind, placebo-controlled, dose-escalation H5N1 Phase 1 trials were conducted in approximately 100 healthy volunteers age 18 to 45 at three U.S. clinical sites. The trials were designed to assess safety and immunogenicity following vaccination, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines at various doses. The vaccines were well-tolerated in the trial, and induced antibody responses and T-cell responses against a matching strain of influenza virus, and cross-clade antibody responses against different strains.
What They Do: Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
Fuel Tech, Inc. (Nasdaq: FTEK) $6.20. Today announced receipt of air pollution control contracts totaling $2.0 million.
Principal among these was the award of two ULTRA systems for two 660 MW units in a single power generation site in northwest China. The systems will provide ammonia reagent in support of large coal-fired electric generating units outfitted with selective catalytic reduction (SCR) systems for nitrogen oxide (NOx) control. Equipment deliveries are scheduled for the third and fourth quarters of 2010.
Fuel Tech’s ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent in the selective catalytic reduction of NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia.
What They Do: Fuel Tech is a leading technology company engaged in the worldwide
development, commercialization and application of state-of-the-art proprietary
technologies for air pollution control, process optimization, and advanced
engineering services.
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