|Prosensa Reports Initial Findings from Further Clinical Data Analyses of Drisapersen; Alexion to Report Q4, FY 2013|
|By Staff and Wire Reports|
|Thursday, 16 January 2014 19:54|
Prosensa Holding N.V. (NASDAQ: RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet medical need, announced initial findings from further analyses from the aggregate data from the clinical development program of drisapersen for the treatment of Duchenne Muscular Dystrophy (DMD).
"We are encouraged by these results that suggest that treating earlier in the disease and treating longer shows a delay in the progression of the disease," said Hans Schikan, Prosensa's Chief Executive Officer. "These data encourage us to engage patient groups, clinical experts and regulators to explore a path forward for drisapersen, which includes the possibility of re-dosing."
Schikan will be presenting details of the further data analyses at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2014 at 10:00 AM Pacific Time. A live webcast of the presentation can be accessed through the Investors & Media section of the Prosensa corporate website at http://ir.prosensa.eu/events.cfm and will be archived for 90 days.
With data from more than 300 patients Prosensa has the largest clinical data set in DMD. In order to advance the general understanding of DMD, Prosensa has also announced that it will make certain data from the drisapersen clinical program available to the scientific community. In addition it has initiated a study to better understand the natural history of DMD and is also exploring potential biomarkers that could be of use as indicators of efficacy in DMD clinical trials.
The subset analyses focus on outcomes in DMD boys seven years or younger and those over seven years old as measured by the six-minute walk test (6MWT). In all studies, a treatment difference was seen in the younger patient population.
Notably, the preliminary analysis of the 96 week extension data from those participating in the phase III DMD114044 (DEMAND III) study shows a 49 meter difference between those on continual treatment (n=52) and those who had been on placebo for 48 weeks followed by active drug (n=31). Those previously participating in the DMD114117 study (DEMAND II) showed a 52 meter difference at 96 weeks (n=13, n=17, respectively).
Key safety findings are consistent with previous observations, including injection site reactions, proteinuria and mild to severe thrombocytopenia.
Schikan concludes, "We will continue to work closely with patient groups, clinical experts and regulators to ensure that we leave no stone unturned to bring treatments to boys affected by DMD."
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced that the Company will report its financial results for the fourth quarter and year ended December 31, 2013 on Thursday, January 30, 2014 before the US financial markets open. Following the release of the financial results, Alexion management will conduct a conference call and audio web cast on Thursday, January 30, 2014, at 10:00 a.m. Eastern Time (ET).
To participate in this conference call, dial 888-487-0361 (USA) or 719-325-2249 (International), passcode 9926357 shortly before 10:00 a.m. ET. A replay of the call will be available from 1:00 p.m. ET through a limited time thereafter. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 9926357. The audio web cast can be accessed on the Investor page of www.alexionpharma.com.
Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the District of Massachusetts on behalf of purchasers (the "Class") of securities of Aegerion Pharmaceuticals, Inc. (NASDAQ: AEGR) during the period of March 15, 2012 and January 9, 2014 (the "Class Period").
Cerner Corp. (Nasdaq:CERN) announced successful client deployments of the Ambulatory EMR Project supported by Canada Health Infoway to improve quality and accessibility of clinical documentation across the inpatient and outpatient venues of care while reducing costs of transcription and document scanning.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that company will conduct a non-deal road show, with meetings in Silicon Valley and New York for one week in February 2014.
Easton Pharmaceuticals Inc. (OTC: EAPH), a specialty pharmaceutical company that owns, designs, develops, and markets an array of topically-delivered drugs and therapeutic healthcare products, today announces an update to its previously announced Medical Marijuana initiatives.
EnWave Corporation (TSX VENTURE:ENW) (FRANKFURT:E4U), announced today that it has signed an extension with Gay Lea Foods Cooperative Ltd. ("Gay Lea") to allow them to continue working with the Company's Radiant Energy Vacuum ("REV™") technology for an additional 6 month period.
Golden Age Resources Inc., (OTC Pink: GDAR) announced today that its President and CEO was interviewed by CEO Live TV.
Medifocus Inc. (TSX VENTURE:MFS) (OTCQX:MDFZF) announced today the extension of the final closing of its non-brokered private placement (the Offering) of $6,000,000 previously announced in August 2013.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Center for Diagnostic Imaging (CDI), a national network of high-quality, cost-effective, outpatient medical imaging and related service providers, has extended their Merge partnership to include iConnect Network.
Micrel, Inc. (NASDAQ: MCRL), an industry leader in high-performance linear and power solutions, LAN and timing and communications solutions, will announce financial results for the fourth quarter and year ended December 31, 2013 after the market closes on Thursday, January 30, 2014.
Nuvilex, Inc. (OTCQB: NVLX) and a host of marijuana companies are keeping a close eye on what is happening with a petition drive in Florida to get the use of medical marijuana on ballots in time for the November election.
OPTIMIZERx Corporation (OTCQB: OPRX) today announced that its Chairman and CEO Mr. David Harrell will present at "TEN"; Noble Financial Capital Markets' Tenth Annual Equity Conference at Club Med in Sandpiper Bay, Florida, on Monday January 20, 2014 at 9:30 AM Eastern Time.
Palatin Technologies, Inc. (NYSE MKT: PTN), announced today that Dr. Carl Spana, President and Chief Executive Officer, will present at "TEN", Noble Financial Capital Markets' Tenth Annual Equity Conference at Club Med in Sandpiper Bay, Florida, on Monday, January 20, 2014 at 11:30 a.m. Eastern Time.
Prosensa Holding N.V. (NASDAQ: RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet medical need, today announced initial findings from further analyses from the aggregate data from the clinical development program of drisapersen for the treatment of Duchenne Muscular Dystrophy (DMD).
Stevia First Corp.(OTCQB: STVF), an early-stage agribusiness based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, today announced that its Company CEO, Robert Brooke will present at "TEN"; Noble Financial Capital Markets' Tenth Annual Equity Conference at Club Med in Sandpiper Bay, Florida, on Monday, January 20, 2014 at 4:30 pm EST in Room 1.