Jaguar Animal Health Announces Positive Topline Results of University Study of Second-Generation Formulation of Neonorm Calf and Commercialization Strategy Updates

Advances commercialization strategy for equine and companion animal drug product candidates
 
SAN FRANCISCO -- Jaguar Animal Health, Inc. (JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced positive topline results today from its study conducted in conjunction with researchers from Cornell University College of Veterinary Medicine (“Cornell”) to evaluate the efficacy of the prophylactic use of a second-generation, powder formulation of Neonorm™ Calf, administered in liquid, on naturally occurring diarrhea in preweaned dairy calves and to investigate the possible prebiotic benefit of the product.
 
Neonorm™ Calf, one of the Company’s lead non-prescription products, has been formulated and clinically tested to help proactively retain fluid in dairy calves and reduce the severity of diarrhea—aiding the animals in avoiding debilitating, dangerous levels of dehydration associated with scours. The powder form of the product allows for ease of administration for entire herd management.
Published: 17 June 2016
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Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin(TM) by FDA

Company remains on track and anticipates final submission in Q4 2016 FDA accepts Spectral's 510(k) filing for its standalone pump for review
TORONTO, ONTARIO--(Marketwired - Jun 16, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (EDT.TO) (EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016.
 
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, President and CEO of Spectral. "This particular section contains key pre-clinical data on the use of Toraymyxin™ for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need."
Published: 16 June 2016
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Capricor Therapeutics Reports Positive 12-Month Data from the DYNAMIC Clinical Trial

CAP-1002 Demonstrates Durable Efficacy Signal Over 12 Months in Patients with Advanced Heart Failure
 
LOS ANGELES, June 16, 2016 -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced positive preliminary 12-month data from its DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial, which evaluated CAP-1002 in patients with advanced heart failure. CAP-1002 is Capricor's investigational allogeneic cardiosphere-derived cell (CDC) therapy.
 
In DYNAMIC, 14 patients with New York Heart Association (NYHA) Class III heart failure were treated with multi-vessel intracoronary infusion of CAP-1002 in four escalating dose cohorts. All patients received a one-time, triple-vessel infusion of CAP-1002 at doses ranging from 37.5 million to 75 million cells. Patients were followed for 12 months, and all echocardiographic studies were read by a core lab.
Published: 16 June 2016
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Pulmatrix's iSperse(TM) Drug Delivery Potential "Game Changer" In Lung Disease Battle

In An Interview with CEOCFO Magazine, Dr. Robert Clarke Explains How Pulmatrix's Innovative Inhaled Drugs Can Fight Serious Infections and Tackle Major Unmet Medical Needs
 
PHILADELPHIA, PA / June 13, 2016 / CEOCFO Magazine, an independent investment and B2B publication that conducts interviews with company CEOs, announced today that it has published an interview with Robert Clarke, PhD, CEO of Pulmatrix, Inc. (PULM).
 
As Dr. Clarke describes in the interview, Pulmatrix is a small pharmaceutical company developinginnovative inhaled drugs to treat respiratory diseases. "Specifically, we look at COPD, asthma, cystic fibrosis, and idiopathic pulmonary fibrosis, all of which are major diseases of the lung," Dr. Clarke says.
 
Pulmatrix has created a novel engineered dry powder technology, called iSPERSE™, for delivering drugs deep into the lungs. "What differentiates it from traditional inhaled approaches is that the particles fly very easily into the patients' airways," Dr. Clarke explains. That boosts the efficiency of drug delivery and makes it possible to deliver high doses when needed.
Published: 16 June 2016
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Cellectar Biosciences Announces Results of In Vivo Study Demonstrating PDC Platform Delivery of Paclitaxel to be Superior in Tumor Targeting to Free Paclitaxel

CLR 1602 Tumor Selectivity Shown to be Approximately 30 Times Greater than Paclitaxel Alone
 
MADISON, Wis., June 15, 2016 -- Cellectar Biosciences, Inc. (CLRB) ("the company"), an oncology-focused biotechnology company, today announces the results of a preliminary tumor-targeting study that shows its prototype paclitaxel chemotherapeutic conjugate, CLR 1602, may be up to 30 times more tumor selective in comparison to free paclitaxel.
 
The preliminary in vivo study demonstrated that tumor uptake of CLR 1602’s paclitaxel payload increased by more than 30-fold over free paclitaxel, and also displayed an extended plasma half-life relative to free paclitaxel. The extended plasma half-life may, in part, explain the enhanced tumor uptake. Unlike free paclitaxel, which was rapidly cleared from plasma within 24 hours, CLR 1602 displayed prolonged retention even at 96 hours.
Published: 15 June 2016
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  2. Sophiris Bio Inc ( SPHS )
  3. Jaguar Animal Health Inc ( JAGX )
  4. Sarepta Therapeutics Inc ( SRPT )
  5. Oncothyreon Inc ( ONTY )