Bio PRs. Acasti Pharma Inc., a Neptune Techn
Post# of 63700
Posted On: 12/18/2012 7:56:22 AM
Bio PRs.
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.
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced the appointment of Joel Schaedler as vice president of market access and Daniel Martin as vice president of marketing.
BioLargo, Inc. (OTCBB: BLGO) announced today that it had accomplished a number of significant achievements in its march toward commercialization of advanced wound care products featuring its patented BioLargo technology.
BioNeutral Group, Inc. (OTCBB: BONU) a specialty life science technology based company is proud to announce today that the Board of Directors of BioNeutral has appointed Robert Machinist as Chairman of its audit committee, and Ben Hanafin as Chairman of its executive compensation committee.
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.
Entia Biosciences (OTCBB: ERGO), a food science biotechnology company and emerging leader in the fields of Nutrigenomics and Targeted Nutrition, has received a Patent Notice of Allowance from the Canadian Intellectual Property Office covering the use of Ergothioneine and its genetic transporter (SLC22A4) in the treatment of a wide variety of diseases, including those affecting the immune and central nervous systems.
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.
La Jolla Pharmaceutical Company (OTCQB: LJPC) (the "Company" and "La Jolla"), a leader in the development of therapeutics that target galectin-3, announced today the results of a mouse study examining the effect of GCS-100 on liver fibrosis.
LiveWire Ergogenics, Inc. (OTCBB: LVVV) (OTCQB: LVVV), makers of the innovative LiveWire Energy™ Chew products, announced today the release of an in-depth initiation report by Patrick Murphy, CFA, principal of fee-based independent research firm Murphy Analytics.
Medifocus Inc. (TSX VENTURE:MFS) (OTCQX:MDFZF) (Medifocusor the Company) announces that it granted incentive stock options to the directors and officers of the Company to purchase an aggregate of 4,825,000 common shares.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today announced that it is offering a special MMR Platinum service which is replacing the MedicAlert® Gold ("MAGold") service that has been powered by MyMedicalRecords for more than six years.
Neurobiological Technologies, Inc. (OTC Markets: NTII) (NTI or the Company) announced today that its board of directors has declared an extraordinary dividend of $0.05 per share of common stock, which will be paid on December 27, 2012 to stockholders of record as of December 20, 2012.
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.
SmartMetric, Inc. (OTCQB: SMME) ("SmartMetric"), developer of "Chip & Swipe"™ Credit, Health and Identity Biometric Activated and safeguarded memory products, such as the SmartMetric, Inc. Biometric fingerprint activated MedicalKeyring (www.medicalkeyring.com) that is soon to be released in the United States.
VaporBrands International, Inc. (PINKSHEETS: VAPR) ("VAPR") is pleased to announce today that Tom Herdman has been appointed Vice President Marketing of VAPR's Asian Sales and Distribution
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.
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced the appointment of Joel Schaedler as vice president of market access and Daniel Martin as vice president of marketing.
BioLargo, Inc. (OTCBB: BLGO) announced today that it had accomplished a number of significant achievements in its march toward commercialization of advanced wound care products featuring its patented BioLargo technology.
BioNeutral Group, Inc. (OTCBB: BONU) a specialty life science technology based company is proud to announce today that the Board of Directors of BioNeutral has appointed Robert Machinist as Chairman of its audit committee, and Ben Hanafin as Chairman of its executive compensation committee.
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.
Entia Biosciences (OTCBB: ERGO), a food science biotechnology company and emerging leader in the fields of Nutrigenomics and Targeted Nutrition, has received a Patent Notice of Allowance from the Canadian Intellectual Property Office covering the use of Ergothioneine and its genetic transporter (SLC22A4) in the treatment of a wide variety of diseases, including those affecting the immune and central nervous systems.
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.
La Jolla Pharmaceutical Company (OTCQB: LJPC) (the "Company" and "La Jolla"), a leader in the development of therapeutics that target galectin-3, announced today the results of a mouse study examining the effect of GCS-100 on liver fibrosis.
LiveWire Ergogenics, Inc. (OTCBB: LVVV) (OTCQB: LVVV), makers of the innovative LiveWire Energy™ Chew products, announced today the release of an in-depth initiation report by Patrick Murphy, CFA, principal of fee-based independent research firm Murphy Analytics.
Medifocus Inc. (TSX VENTURE:MFS) (OTCQX:MDFZF) (Medifocusor the Company) announces that it granted incentive stock options to the directors and officers of the Company to purchase an aggregate of 4,825,000 common shares.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, today announced that it is offering a special MMR Platinum service which is replacing the MedicAlert® Gold ("MAGold") service that has been powered by MyMedicalRecords for more than six years.
Neurobiological Technologies, Inc. (OTC Markets: NTII) (NTI or the Company) announced today that its board of directors has declared an extraordinary dividend of $0.05 per share of common stock, which will be paid on December 27, 2012 to stockholders of record as of December 20, 2012.
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.
SmartMetric, Inc. (OTCQB: SMME) ("SmartMetric"), developer of "Chip & Swipe"™ Credit, Health and Identity Biometric Activated and safeguarded memory products, such as the SmartMetric, Inc. Biometric fingerprint activated MedicalKeyring (www.medicalkeyring.com) that is soon to be released in the United States.
VaporBrands International, Inc. (PINKSHEETS: VAPR) ("VAPR") is pleased to announce today that Tom Herdman has been appointed Vice President Marketing of VAPR's Asian Sales and Distribution
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