18.06.2014 06:57:29
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CANF In For The Long Haul, CLTX Awaits Busy Q4, DSCO Gets Richer, ECYT Slumps
(RTTNews) - Can-Fite BioPharma Ltd. (CANF) has completed enrollment in its phase II/III trial of its drug candidate CF101 for the treatment of psoriasis with over 300 patients through 17 clinical centers in the U.S., Israel and Europe. Top line results from the trial are expected in the first quarter of 2015.
CANF closed Tuesday's trading at $3.70, unchanged from the previous day's close.
Celsus Therapeutics Plc (CLTX) has received the go-ahead from the Israeli Ministry of Health to conduct a phase II trial of MRX-6 cream 2% in pediatric patients with atopic dermatitis. The company expects to report results from this trial in the fourth quarter of 2014.
A phase II clinical program of MRX-6 cream 2% is expected to begin in the U.S. in early 2015.
Discovery Laboratories Inc. (DSCO) has been awarded the final $1.9 million of a $2.4 million Fast Track Small Business Innovation Research Grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health. The fund will support the ongoing phase 2a clinical trial for AEROSURF, Discovery Labs' investigational combination drug/device product for respiratory distress syndrome (RDS) in premature infants.
DSCO closed Tuesday's trading at $1.73, up 1.17%.
Shares of Endocyte Inc. (ECYT) dropped more than 19 percent to $6.22 in extended trading on Tuesday, following Merck & Co.'s (MRK) decision not to pursue development of the investigational cancer treatment Vintafolide.
Vintafolide was licensed by Merck from Endocyte in 2012 in a deal valued at up to $1 billion.
Merck pulled the plug on a phase III trial of Vintafolide in ovarian cancer, dubbed PROCEED, last month as the drug candidate did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival.
Vintafolide is also under a phase 2b trial in patients with non-small cell lung cancer, dubbed TARGET. According to initial results announced in March, the TARGET trial met its primary progression-free-survival (PFS) endpoint and overall response rates and early overall survival (OS) trends were positive.
Now that Endocyte has regained the worldwide rights to Vintafolide in all indications from Merck, Endocyte will evaluate Vintafolide for future development opportunities pending final results from the Phase 2b TARGET trial.
Endologix Inc. (ELGX) has achieved $10 million in trailing twelve month international sales of the Nellix EndoVascular Aneurysm Sealing System. The achievement triggers a milestone payment to the former Nellix, Inc. stockholders, in the form of 2,666,555 shares of Endologix common stock.
Flexion Therapeutics Inc. (FLXN) announced positive topline results from a phase 2a study of FX006, which demonstrated, for the first time, that a single intra-articular injection of FX006 can provide therapeutic concentrations of drug in joint fluid for at least 12 weeks.
The company expects to share more details from the phase 2a trial at an upcoming scientific meeting and to receive topline data from a phase 2b confirmatory trial in the first half of 2015.
FLXN closed Tuesday's trading at $12.88, down 1.15%. In after-hours, the stock was up 1.32% to $13.05.
Mirati Therapeutics Inc. (MRTX) announced that its investigational compound Mocetinostat has been granted Orphan Drug Designation by FDA as a treatment for myelodysplastic syndrome.
Mocetinostat is being developed in Phase 2 clinical studies in combination with approved cancer drug Vidaza as a treatment for intermediate and high-risk MDS, as well as a single agent treatment in patients with diffuse large B-cell lymphoma (DLBCL) and bladder cancer targeting specific genetic mutations in histone acetylation that increase the likelihood of response in tumor cells.
MRTX closed Tuesday's trading at $19.69, down 0.51%.
Recro Pharma Inc. (REPH) has dosed the first patient in a phase IIb clinical trial of Dex-IN in patients undergoing bunionectomy surgery. The company expects to report top line data from this trial by the end of 2014.
REPH closed Tuesday's trading at $7.32, up 1.10%.
The UK's cost-effectiveness watchdog National Institute for Health and Clinical Excellence, or NICE, has recommended the use of Sucampo Pharmaceuticals Inc.'s (SCMP) AMITIZA in the treatment of chronic idiopathic constipation and associated symptoms in adults who have failed laxatives.
AMITIZA has been commercially available in the U.K. since December 2013.
SCMP closed Tuesday's trading at $7.40, up 0.14%.
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