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Source: CollPlant Ltd & reported by http://www.prnewswire.com/
CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive final extended clinical trial results for Vergenix™STR for the treatment of tendinopathy. The Company anticipates receiving CE mark approval for Vergenix™STR in the third quarter of 2016.

The prospective, open label, single-arm trial was conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), and the trial's objective was to demonstrate the safety and performance of Vergenix™STR in 40 patients suffering from inflammation of the elbow tendon, commonly referred to as tennis elbow. All patients were followed for a total of six months after a single treatment. Product performance was assessed by measuring reduction in pain and recovery of motion, as reported by the specific Patient Related Tennis Elbow Evaluation questionnaire ("PRTEE").

At three months following treatment, Vergenix™STR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, Vergenix™STR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.
Read more: http://www.prnewswire.com/news-releases/collplant-reports-positive-final-extended-clinical-trial-results-with-vergenixstr-for-treatment-of-tendinopathy-590460101.html

Source: Radius Health & reported by https://globenewswire.com/
WALTHAM, Mass., Aug. 16, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and other endocrine diseases, today announced that positive results from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were published in the Journal of the American Medical Association (JAMA). This landmark trial enrolled 2,463 patients to evaluate the safety and efficacy of investigational drug abaloparatide for the treatment of postmenopausal women with osteoporosis. The ACTIVE results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (p < 0.001) and nonvertebral fractures (p = 0.049) compared to placebo. “The landmark ACTIVE trial results are important and further validate abaloparatide’s potential to consistently, substantially and rapidly reduce both new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis,” said Dr. Paul Miller, Medical Director at the Colorado Center for Bone Research and lead author of the paper. “Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for affected women by diminishing their independence and quality of life. There is a great unmet medical need for therapies which could provide more consistent potent and early benefits to patients.” Read more: https://globenewswire.com/news-release/2016/08/16/864583/0/en/JAMA-Publishes-Positive-Phase-3-Data-for-Abaloparatide-in-Postmenopausal-Women-With-Osteoporosis.html

Source: http://www.businesswire.com/
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive top-line results from the Phase 2b AURA-LV (AURA) clinical study in patients with active lupus nephritis (LN). The trial achieved its primary endpoint, demonstrating statistically significantly greater complete remission (CR) (as defined by confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg at 24 weeks and confirmed at 26 weeks) in patients treated with 23.7 mg of voclosporin twice daily (p=0.045). Both treatment arms, 23.7 mg and 35.9 mg twice daily also showed a statistically significant improvement in the rate of achieving partial remission (PR) at 24 weeks (p=0.007; p=0.024). Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5 mg/day by week 8 and 2.5 mg by week 16. No unexpected safety signals were observed and voclosporin was shown to be well tolerated.

“We are very pleased by these encouraging results and are grateful to those that participated in our clinical trials,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “The AURA study was conducted under rigorous and stringent criteria, enhancing our confidence in voclosporin’s potential ability to provide a substantial improvement over the currently accepted standard of care, especially given that study participants had such active disease and were exposed to such a low corticosteroid load. We continue to work diligently towards our goal of improving long-term outcomes for these patients.”

Read more: http://www.businesswire.com/news/home/20160815005340/en/Aurinia-Pharmaceuticals-Announces-Voclosporin-Meets-Primary-Endpoint

Source: Ascendis Pharma & reported by http://www.prnewswire.com/
COPENHAGEN, Denmark, Aug. 11, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biopharmaceutical company that applies its innovative TransCon technology to address significant unmet medical needs, today announced the initiation of the global Phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD). The heiGHt Trial initiation follows End-of-Phase 2 discussions with the U.S. Food and Drug Administration (FDA), as well as various discussions with regulatory agencies worldwide.

"The Phase 3 heiGHt Trial initiation marks a major milestone for Ascendis and our TransCon Growth Hormone program as we move into the next stage of development," said Jonathan A. Leff, M.D., Senior Vice President and Chief Medical Officer at Ascendis. "This pivotal trial mirrors the design of our Phase 2 study in pediatric GHD that demonstrated comparable safety, efficacy, and tolerability of once-weekly TransCon Growth Hormone to a daily growth hormone therapy. This global trial is designed to support planned regulatory applications worldwide, including in the United States and Europe."
Dr. Leff continued, "The Phase 2 data for our once-weekly sustained-release TransCon Growth Hormone demonstrated the strong efficacy and favorable safety, tolerability, and convenience profile of our product candidate. As the only long-acting growth hormone that provides the same mode of action as daily growth hormone, we believe TransCon Growth Hormone can become a best-in-class option for physicians and patients to address the ongoing unmet need for an effective and convenient long-acting growth hormone therapy."
Read more: http://www.prnewswire.com/news-releases/ascendis-pharma-as-initiates-phase-3-registration-trial-for-transcon-growth-hormone-in-children-with-growth-hormone-deficiency-300312262.html

Source: https://globenewswire.com/
Copenhagen, 11 August 2016 – Zealand Pharma (Zealand) announces supportive results from a Phase II trial with a single-dose version of dasiglucagon as rescue treatment of severe hypoglycemia in insulin dependent diabetic patients. Dasiglucagon, formerly referred to as ZP4207, is a glucagon peptide analog, invented and fully owned by Zealand and observed to have a favorable physical and chemical stability in liquid solution. In June 2016, dasiglucagon was proposed as an International Nonproprietary Name (pINN) for this product candidate.

Severe hypoglycemia is a potential life threatening condition and the most feared side effect associated with insulin treatment of diabetes. At present, hypoglycemia rescue treatments are based on native glucagon and solely available as a lyophilized powder, which requires reconstitution with sterile water in a multi-step process prior to use.

The primary objective of this Phase II trial was to characterize the pharmacological profile of an optimized formulation of dasiglucagon and compare it to an approved glucagon rescue product. Results from the trial showed that all subjects treated with one of the three highest doses of dasiglucagon or with the approved glucagon product achieved a blood glucose concentration of >70 mg/dL within 30 minutes of dosing. In the same dose groups, time to clinically relevant plasma glucose increases of >20 mg/dL was shown to be similar for dasiglucagon and approved glucagon with a median time of 9-10 minutes. In the trial, dasiglucagon was observed to be well tolerated and have a similar safety profile compared to approved glucagon. The full Phase II results will be published at a later date.

Read more: https://globenewswire.com/news-release/2016/08/11/863678/0/en/Phase-II-results-with-dasiglucagon-ZP4207-support-its-potential-for-use-in-a-ready-to-use-rescue-pen-to-treat-severe-hypoglycemia-in-diabetes.html

Source: http://www.prometic.com/
LAVAL, QUEBEC, CANADA – August 11, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that it has completed enrolment of the congenital plasminogen deficient patients in its pivotal phase 2/3 clinical trial required for the accelerated regulatory approval pathway with the Food and Drug Administration (“FDA”).

The FDA has agreed to an accelerated regulatory approval pathway, given the rarity of the condition and the related unmet medical need. To secure an accelerated pathway approval, a drug must treat a serious condition, provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

“We are very pleased with the timely completion of patients’ enrolment in our pivotal plasminogen phase 2/3 trial”, said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The achievement of this important milestone allows us to confidently proceed with the last phase of the plasminogen congenital deficiency clinical program as we get ready to start filing the required BLA modules necessary to secure licensure from the FDA”.

Dr John Moran, Chief Medical Officer of ProMetic commented: “The ongoing clinical trial has enabled us to meet the primary end-point of achieving the targeted increase in plasma concentration of plasminogen and to define the optimal treatment regimen. We have also observed major clinical benefit in patients with long-standing lesions related to their plasminogen deficiency. As in the patients who have been treated outside the trial on an emergency basis, both the rapidity and the magnitude of the improvement has been remarkable, knowing that in many cases the lesions have been present for years”.
Read more: http://www.prometic.com/prometic-completes-patients-enrolment-in-pivotal-plasminogen-phase-23-clinical-trial/

Source: http://www.cardiome.com/
VANCOUVER, Aug. 9, 2016 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that XYDALBA™ (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500mg vials) followed one week later by 500 mg (a single 500mg vial).

"We are pleased that the EMA has approved the single dose administration of XYDALBA™," said Kiran Bhirangi, M.D., Cardiome's Head of Medical Affairs. "This approval aligns the dosing regimen with the U.S. label, but more importantly, it could enhance the convenience of antibiotic administration for both healthcare providers and their patients. We anticipate that XYDALBA™ will be available to physicians within some of the major territories under license by Cardiome during the fourth quarter of 2016."

XYDALBA™ was approved by the EMA in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.
Read more: http://www.cardiome.com/investors/news/archives/2016/cardiome-announces-xydalba%E2%84%A2-single-dose-infusion-approval-european-medi

Source: http://www.phasebio.com/
Malvern, PA, August 8, 2016 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on biopolymer-based drugs for orphan, cardiopulmonary and metabolic diseases, today announced the dosing of the first patients in Part One of a Phase 2a clinical study of PB1046, a once-weekly vasoactive intestinal peptide (VIP) receptor agonist in development for the treatment of cardiopulmonary disorders. Part One will assess PB1046 in adult subjects with stable heart failure with reduced ejection fraction. Part Two, which PhaseBio expects to initiate later in 2016, will examine PB1046 in subjects with cardiac dysfunction secondary to Duchenne muscular dystrophy.

“There is a clear need for heart failure treatments that both alleviate symptoms and slow or reverse disease progression,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “We look forward to building on our compelling preclinical data in models of heart failure, and the positive data from our Phase 1 studies, which demonstrated the safety and tolerability of PB1046 at efficacious doses in patients with hypertension.”

Part One is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic response following four weeks of once-weekly subcutaneous injections of PB1046 in 28 adults with heart failure. Dose levels shown to be safe and well-tolerated in Part One will be selected for evaluation in Part Two of the study.
Read more: http://www.phasebio.com/pages/news/releases/PhaseBioAnnouncesDosingofFirstPatientsinTwo-PartPhase2aStudyofPB1046inCardiopulmonaryDi.php