|ACADIA Issues Multiple Presentations of Data from Trial of Pimavanserin; MEI Begins Phase II Trial of Pracinostat|
|By Staff and Wire Reports|
|Tuesday, 18 June 2013 18:51|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 18, 2013.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, presented data today from its Phase III program with pimavanserin for Parkinson's disease psychosis (PDP), including data from its pivotal -020 Study and the related, open-label safety extension study, at a poster session at the 17^th International Congress of Parkinson's Disease and Movement Disorders, which is taking place in Sydney, Australia from June 17 - 20, 2013.
“Data from our open-label safety extension study indicate that long-term administration of pimavanserin is generally safe and well tolerated in PDP patients and suggest that duration of antipsychotic effect may be maintained for longer than the six weeks investigated in our pivotal -020 Study,” said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. “The overall efficacy and safety profile observed to date shows that pimavanserin has the potential to offer a new treatment option that may provide significant advantages relative to current antipsychotics used off-label for the treatment of PDP.”
MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patients have been dosed in a Phase II clinical trial of its lead drug candidate Pracinostat in combination with Vidaza (azacitidine) in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS). The randomized, double-blind trial is designed to evaluate the safety and efficacy of Pracinostat compared to placebo when combined with Vidaza, a drug approved by the U.S. Food & Drug Administration (FDA) for the treatment of MDS.
Results from an earlier pilot study of Pracinostat in combination with Vidaza in patients with intermediate-2 or high-risk MDS presented at the American Society of Hematology (ASH) Annual Meeting in December 2012 showed an overall response rate of 89% (eight out of nine), including seven patients who achieved either a complete remission (CR) or a complete remission with incomplete blood count recovery (CRi).
"The initiation of this randomized Phase II trial is an important milestone in the clinical development of Pracinostat," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "The results from the pilot study reported at ASH were very exciting and helped to inform the design of this more robust, placebo-controlled trial. Now, our goal is to build on these preliminary data and get a more precise estimate of the clinical benefit of Pracinostat in combination with standard-of-care."
The multicenter Phase II trial is expected to enroll 100 patients with a one-to-one randomization. Completion of enrollment is anticipated by June 2014 with topline data in December 2014. The primary endpoint of the study is complete remission (CR). Secondary endpoints include overall response rate (CR+CRi+PR), hematologic improvement, duration of response, progression-free survival, rate of leukemic transformation, overall survival and safety. The trial is being conducted in collaboration with the Sarah Cannon Research Institute; Dr. Guillermo Garcia-Manero of the MD Anderson Cancer Center is the principal investigator. Additional information regarding the trial is available at www.clinicaltrials.gov.
"This represents the first in a series of Phase II studies we have planned for Pracinostat in the months ahead," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "We believe that Pracinostat truly has the potential to become a best-in-class drug. We intend to execute a comprehensive development program in order to realize its full potential and determine the most efficient registration path forward."
In addition to the randomized Phase II clinical trial in frontline MDS, the Company is also preparing for the initiation of two open-label Phase II trials of Pracinostat: one in combination with Vidaza in frontline acute myeloid leukemia (AML) in the fall of 2013 and the other in combination with Vidaza or Dacogen^® (decitabine) in patients with refractory MDS soon thereafter.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, presented data today from its Phase III program with pimavanserin for Parkinson’s disease psychosis (PDP), including data from its pivotal -020 Study and the related, open-label safety extension study, at a poster session at the 17th International Congress of Parkinson’s Disease and Movement Disorders, which is taking place in Sydney, Australia from June 17 - 20, 2013.
AMRI (NASDAQ: AMRI) announced today that its Burlington, Mass., site has received approval to expand its current U.S. Drug Enforcement Administration (DEA) registration to handle Schedule 2 and 2N controlled substances.
At the 2013 International Paris Air Show, Astro-Med, Inc (NASDAQ: ALOT) announced it has been awarded the flight deck printer contract for the Rockwell Collins (NYSE: COL) Pro Line Fusion flight deck to be installed on Bombardier Global 7000 and Global 8000 aircraft.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management and care coordination, today announced that it was named to Forbes' annual list of America's 25 Fastest-Growing Tech Companies for the second year in a row.
Biodel Inc. (Nasdaq:BIOD) today announced that it is offering to sell, subject to market and other conditions, shares of its common stock in an underwritten public offering.
Bristol-Myers Squibb Company (NYSE: BMY) today announced more than $500,000 in new grants to more than a dozen educational institutions and organizations working to enhance the teaching and learning of science, technology, engineering and mathematics (STEM) in K-12 schools and colleges in New Jersey.
Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR), a leader in functional, renewable plant proteins, will hold a conference call on Tuesday, June 25, 2013 at 5:00 p.m. Eastern time to discuss its results for the fourth quarter and year ended March 31, 2013.
Cerner (Nasdaq:CERN) has launched a pilot program to deliver the Primary Health Network, an innovative model that connects, incentivizes, and aligns consumers and providers toward improved health.
Chembio Diagnostics, Inc. (Nasdaq:CEMI) a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it's SURE CHECK® HIV 1/2 Assay has received CE Mark approval from European regulators.
China Cord Blood Corporation (NYSE: CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its preliminary unaudited financial results for the fourth quarter and full year of fiscal year 2013 ended March 31, 2013.
CodeSmart Holdings, Inc. (OTCQB:FICFD), with its subsidiary, The CODESMART™ Group, Inc. (collectively, "CODESMART™"), a premier ICD-10 education and solutions group that offers CODESMART™ UNIVERSITY, its on-line education solution and customizable training solutions, announces today that it has commenced a strategic partnership with CIRACET Corp. based in Ponce, Puerto Rico to offer ICD-10 consulting and education to the Puerto Rico healthcare market. CIRACET is the largest healthcare consulting firm in the Puerto Rico healthcare market serving the 47 hospitals in Puerto Rico and also over 3,000 physicians.
CollabRx, Inc. (Nasdaq:CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, today announced a collaboration with the thoracic oncology program at the University of Chicago Medical Center, one of the nation's leading cancer treatment centers with innovative clinical and translational research programs in cancer genetics and therapeutics.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, announced today that it is set to join the broad-market Russell 3000® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, 2013, according to a preliminary list of additions posted on June 14, 2013 and available at www.russell.com/indexes.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it received CE Mark (European regulatory approval) for Focal.One®, its new and innovative robotic HIFU device fully dedicated to focal therapy of prostate cancer.
Exact Sciences Corp. (NASDAQ: EXAS) today announced the pricing of its previously announced underwritten public offering of 5.5 million shares of its common stock, offered at a price of $12.35 per share to the public.
Gevo, Inc. (Nasdaq:GEVO) today announced that it has resumed commercial production of isobutanol at its Luverne, Minn. plant in single train mode, successfully utilizing its proprietary Gevo Integrated Fermentation Technology® (GIFT®).
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that population pharmacokinetic (PK) modeling and dosing simulations were reported in The Journal of Clinical Pharmacology based on data from four Phase 2 and 3 trials that collectively enrolled patients with urea cycle disorders (UCDs) ages 2 months to 72 years.
Integrated Environmental Technologies, Ltd. (OTCBB:IEVM), today announced that it entered into an Asset Purchase Agreement with Benchmark Performance Group, Inc. ("Benchmark") to purchase nineteen EcaFlo™ machines owned by Benchmark as well as the rights to the Excelyte® trademark and certain other intangible assets.
MediciNova, Inc. (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced the presentation of preliminary results from a Phase 1b study of MN-166 (ibudilast) in methamphetamine addiction at the 75th Annual Meeting of the College on Problems of Drug Dependence (CPDD) in San Diego on June 18, 2013.
Medical Marijuana Inc. (OTC:MJNA) and PhytoSPHERE Systems are pleased to inform shareholders and the general public that the company has expanded hemp production significantly. With the expansion, the company has increased production of the industry's first natural pharmaceutical-grade CBD-rich oils and derivatives.
Based on its recent analysis of the advanced battery market, Frost & Sullivan recognizes mPhase Technologies, Inc. (OTCBB: XDSL) with the 2013 North America Frost & Sullivan Technology Innovation Award for its pioneering nanobattery technology.
Nuvilex, Inc.'s (OTCQB: NVLX) subsidiary, Medical Marijuana Sciences, Inc., has already declared its focus will be on pancreatic cancer and cancers of the brain, and that research will put the company right in the middle of what is turning into a real explosion in the industry.
OxySure® Systems, Inc. (OTCQB: OXYS), a medical device innovator of life-saving, easy-to-use emergency oxygen solutions with its "oxygen from powder" technology, today announced that it has signed a non-exclusive distributor agreement with Aventric Technologies ("Aventric") to sell OxySure's full portfolio of products.
PositiveID Corporation (OTCBB:PSID), a developer of biological detection and diagnostics solutions, today published to its website a presentation given by Chief Technology Advisor Dr. Kimothy Smith at the 21st International Conference for Biodetection Technologies 2013 in Alexandria, VA.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it closed a $20 million debt financing with Hercules Technology Growth Capital, Inc.
Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 IU/kg. Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the signing of a Distribution Agreement with S4S (UK) Limited for exclusive distribution rights in the United States to market the U.S. patented and FDA cleared titratable sleep appliance hardware sold under the trademark "Sleepwell™".
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has completed its previously announced call for redemption of $400 million in aggregate principal amount of 3.35% Convertible Senior Subordinated Notes due 2015.