Bio PRs big board. Acasti Pharma Inc., a N
Post# of 5789
Posted On: 12/18/2012 7:59:01 AM
Bio PRs big board.
Acasti Pharma Inc., a Neptune Technologies & Bioressources Inc. (NASDAQ: NEPT) subsidiary, announces a clinical study update and announces the first ever human data of safety and efficacy of its patented prescription drug candidate CaPre®.
Acasti has achieved significant progress in the two presently ongoing clinical studies. The registrational phase II double blind placebo controlled clinical study has completed its first of two interim analysis. The review committee assembled to evaluate the progress of the study reviewed the interim analysis relative to drug safety and efficacy, and agreed, unanimously, that the study should continue as planned. All committee members were convinced that there are no concerning toxicity issues and that the signals of possible CaPre® therapeutic effect, noted as reduction of triglyceride in the groups evaluated, were reassuring and clinically significant to allow the further continuation of the study. As it is customary, the data was provided to the committee members blind, meaning that the identity of the three groups was not revealed. Since the data showed no safety concerns and a strong clinical signal the decision was made, by the committee, that it is safe to continue the study and that there is no need to unblind the data.
The second phase II open label clinical study should be completed by the end of the first quarter of 2013. It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4g/day CaPre® treatment group, following a FDA recommendation to evaluate the effect of a 4g dose. Acasti was able to obtain completed clinical data from a cohort of patients that completed an eight-week treatment with 2g CaPre® per day, which will not be included in the primary analysis under the amended protocol. Test results of 23 patients were analysed of whom 19 had baseline triglyceride levels between 204 and 476mg/dl. The data showed a statistically significant 25% (p<0.05) reduction in triglycerides after eight weeks of treatment. Besides the important decrease in triglycerides, CaPre® also decreased Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and non-HDL lipids and increased High Density Lipoprotein (HDL).
The first patient has been implanted with the Boston Scientific Corporation (NYSE: BSX) next generation INGEVITY™ pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads. Pacing leads are insulated wires that connect an implantable pacemaker to the heart for treatment of bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen. Pacemakers work in conjunction with leads to sense and stimulate (or pace) the heart, thus maintaining an appropriate heart rate for a given level of physical activity.
The INGEVITY pacing lead platform is designed to provide key enhancements in maneuverability, reliability , fixation and electrical performance compared to standard leads available today. In addition, INGEVITY leads are specifically engineered to function in the magnetic resonance imaging (MRI) environment. Many patients with pacemakers are restricted from undergoing MRI scans, as powerful magnets may interfere with pacemaker functionality.
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OTREXUP™, a combination product for the delivery of methotrexate (MTX) using Medi-Jet™ technology.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced a significant capacity expansion of its Kangaroo™ ePump and Kangaroo™ Joey enteral feeding pumps and sets.
GenVec, Inc. (NASDAQ: GNVC) announced today that data were presented on its HSV vaccine program at the Keystone Symposia meeting on Immunological Mechanisms of Vaccination, which is taking place in Ottawa, Ontario from December 13 to December 18, 2012.
GTx, Inc. (Nasdaq: GTXI) today announced that it has attained its enrollment goal for both of its pivotal Phase III clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™ (linaclotide) is now available in pharmacies throughout the United States
Northwest Biotherapeutics, Inc. (NASDAQ: NWBO; NWBOW) (NW Bio),a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that it is scheduled to ring The NASDAQ Stock Market Opening Bell on Tuesday, December 18, 2012 to celebrate the Company's recent financing and up-listing to the NASDAQ Capital Market .
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the Japanese approval of the CoRoent Large Impacted (LI) and CoRoent Large Tapered (LT) titanium alloy implants.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that its Board of Directors has elected N. Anthony Coles, M.D., Chairman of the Board.
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced results for the three and six months ended October 31, 2012.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's non-instrumented molecular diagnostic test -- the AmpliVue C. difficile Assay -- for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification (HDA) with its lateral flow detection technology.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has significantly expanded its intellectual property (IP) around isoquinolinamine, a class of potent anti-cancer compounds.
Acasti Pharma Inc., a Neptune Technologies & Bioressources Inc. (NASDAQ: NEPT) subsidiary, announces a clinical study update and announces the first ever human data of safety and efficacy of its patented prescription drug candidate CaPre®.
Acasti has achieved significant progress in the two presently ongoing clinical studies. The registrational phase II double blind placebo controlled clinical study has completed its first of two interim analysis. The review committee assembled to evaluate the progress of the study reviewed the interim analysis relative to drug safety and efficacy, and agreed, unanimously, that the study should continue as planned. All committee members were convinced that there are no concerning toxicity issues and that the signals of possible CaPre® therapeutic effect, noted as reduction of triglyceride in the groups evaluated, were reassuring and clinically significant to allow the further continuation of the study. As it is customary, the data was provided to the committee members blind, meaning that the identity of the three groups was not revealed. Since the data showed no safety concerns and a strong clinical signal the decision was made, by the committee, that it is safe to continue the study and that there is no need to unblind the data.
The second phase II open label clinical study should be completed by the end of the first quarter of 2013. It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4g/day CaPre® treatment group, following a FDA recommendation to evaluate the effect of a 4g dose. Acasti was able to obtain completed clinical data from a cohort of patients that completed an eight-week treatment with 2g CaPre® per day, which will not be included in the primary analysis under the amended protocol. Test results of 23 patients were analysed of whom 19 had baseline triglyceride levels between 204 and 476mg/dl. The data showed a statistically significant 25% (p<0.05) reduction in triglycerides after eight weeks of treatment. Besides the important decrease in triglycerides, CaPre® also decreased Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and non-HDL lipids and increased High Density Lipoprotein (HDL).
The first patient has been implanted with the Boston Scientific Corporation (NYSE: BSX) next generation INGEVITY™ pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads. Pacing leads are insulated wires that connect an implantable pacemaker to the heart for treatment of bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen. Pacemakers work in conjunction with leads to sense and stimulate (or pace) the heart, thus maintaining an appropriate heart rate for a given level of physical activity.
The INGEVITY pacing lead platform is designed to provide key enhancements in maneuverability, reliability , fixation and electrical performance compared to standard leads available today. In addition, INGEVITY leads are specifically engineered to function in the magnetic resonance imaging (MRI) environment. Many patients with pacemakers are restricted from undergoing MRI scans, as powerful magnets may interfere with pacemaker functionality.
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OTREXUP™, a combination product for the delivery of methotrexate (MTX) using Medi-Jet™ technology.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced a significant capacity expansion of its Kangaroo™ ePump and Kangaroo™ Joey enteral feeding pumps and sets.
GenVec, Inc. (NASDAQ: GNVC) announced today that data were presented on its HSV vaccine program at the Keystone Symposia meeting on Immunological Mechanisms of Vaccination, which is taking place in Ottawa, Ontario from December 13 to December 18, 2012.
GTx, Inc. (Nasdaq: GTXI) today announced that it has attained its enrollment goal for both of its pivotal Phase III clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™ (linaclotide) is now available in pharmacies throughout the United States
Northwest Biotherapeutics, Inc. (NASDAQ: NWBO; NWBOW) (NW Bio),a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that it is scheduled to ring The NASDAQ Stock Market Opening Bell on Tuesday, December 18, 2012 to celebrate the Company's recent financing and up-listing to the NASDAQ Capital Market .
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the Japanese approval of the CoRoent Large Impacted (LI) and CoRoent Large Tapered (LT) titanium alloy implants.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that its Board of Directors has elected N. Anthony Coles, M.D., Chairman of the Board.
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a development stage biomedical company focused on developing oxygen-rich intravenous and topical products, today announced results for the three and six months ended October 31, 2012.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's non-instrumented molecular diagnostic test -- the AmpliVue C. difficile Assay -- for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification (HDA) with its lateral flow detection technology.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has significantly expanded its intellectual property (IP) around isoquinolinamine, a class of potent anti-cancer compounds.
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