|Regeneron Reports Two-Year Results from Phase 3 VISTA Trail of Eylea; Sarepta Announces Positive Safety Results from Phase I Trial of Marburg|
|By Staff and Wire Reports|
|Monday, 10 February 2014 20:00|
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that in the Phase 3 VISTA-DME trial of EYLEA^® (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) and EYLEA 2 mg dosed every two months (after 5 initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation. The 52-week results (primary analyses) from this study have been previously reported.
Patients in the VISTA-DME trial were randomized to receive either EYLEA 2Q4 (n=155), EYLEA 2Q8 (n=152), or the comparator treatment of laser photocoagulation (n=154).
After two years, patients receiving EYLEA 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks). Patients receiving EYLEA 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks).
"These data showed that treatment with EYLEA in this trial improved vision and maintained the improvement over two years in patients with diabetic macular edema," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "These results are particularly encouraging given that 43 percent of patients in this study had previously received anti-VEGF therapy."
In this trial, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the EYLEA treatment groups and the laser control group. AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy. The most frequent ocular AEs observed in the VISTA-DME trial included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular AEs included hypertension, anemia, and urinary tract infection. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) were similar across the treatment groups and the laser control group with events occurring in 13 out of 155 patients in the EYLEA 2Q4 group, 11 out of 152 patients in the EYLEA 2Q8 group, and 9 out of 154 patients in the laser group. Eight out of 155 patients died in the EYLEA 2Q4 group, 4 out of 152 patients in the EYLEA 2Q8 group, and 3 out of 154 patients in the laser treatment group.
Full two-year data from the VISTA-DME trial will be presented at upcoming medical conferences. Two-year data from the similarly designed VIVID-DME trial are expected later in 2014. Both the VISTA-DME and the VIVID-DME trials will continue as planned up to 148 weeks.
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta's advanced and proprietary PMOplus™ chemistry, is the company's lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.
The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.
“We are very encouraged by the AVI-7288 study results announced today,” said Chris Garabedian, president and chief executive officer of Sarepta Therapeutics. “These safety data, combined with previously reported efficacy results showing up to 100 percent survival in infected animals, differentiates AVI-7288 as the most advanced medical countermeasure in development for the treatment of Marburg infection.”
"The new data for AVI-7288 add to a growing body of evidence supporting the safety and activity of Sarepta's PMO-based chemistries,” said Art Krieg, M.D., senior vice president and chief scientific officer of Sarepta Therapeutics. “Our proprietary RNA technologies offer a versatile drug development platform with broad potential utility across a spectrum of therapeutic areas.”
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Pacific Biosciences of California, Inc. (Nasdaq:PACB), provider of the PacBio® RS II DNA Sequencing System, announced that its Single Molecule, Real-Time (SMRT®) Sequencing technology will be featured in nine podium presentations and 29 posters at this year's Advances in Genome Biology and Technology (AGBT) meeting, with more than half presenting research on human and other complex genomes.
Poly Shield Technologies Inc., (OTCQB:SHPR) announces the signing of a consulting agreement with DNV GL to test and evaluate Poly Shield Technologies Inc.'s DSOX-15 Fuel Purification System's technology.
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that it has commenced an underwritten public offering of approximately $75 million of shares of its common stock.
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Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the appointment of Joseph I. DePinto to the newly created position of Executive Vice President and Chief Commercial Officer.
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