Wednesday, December 11, 2013

Baxter submits application to FDA for pediatric indication of Rixubis to treat Hemophilia B

Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B.

The submission was based on a Phase II/III clinical trial, designed to assess the efficacy and safety of Rixubis in 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B.

In 2013, the company had secured FDA approval for Rixubis in the US for adults with hemophilia B and it had filed for marketing approval in Europe in November.

During the trial, patients were treated with a twice-weekly Rixubis prophylaxis regimen (median dose 56 IU/kg) over six months or for a minimum of 50 exposure days (EDs).

The company said that the median annualized bleeding rate (ABR) was 2.0 (0.0 for spontaneous bleeds and joint bleeds).

In the trial nine patients (39.1%) experienced no bleeds and 23 patients (88.5%) were treated with 1-2 infusions.

The company said that out of the 26 bleeds seen in the trial, only two (in two patients) were spontaneous and no reports of inhibitor development, no allergic reactions, and no thrombotic or treatment-related adverse events were observed among the study participants.

Baxter BioScience vice president of global research and development Anders Ullman said the positive results among a pediatric patient population are consistent with those observed in the Rixubis pivotal study among adult patients with hemophilia B.

"We submitted these data as part of our application for a pediatric indication for RIXUBIS to advance effective therapeutic solutions for children with hemophilia B," Ullman said.

New dissolving patch delivers clotting factor directly to injury to stop bleeding faster

Hemorrhage is a primary cause of mortality in trauma patients even though most injuries suffered are potentially survivable. Increasing survival is simply a matter of effectively controlling hemorrhage. Current hemostatic dressings range from simple gauze to aluminosilicates from natural or synthetic clay Combat GauzeTM, or chitosan from shellfish or algae (CeloxTM). These dressings stop the bleeding by direct compression of injured vessels and/or activation of the intrinsic coagulation pathway. In trauma patients however, this system is often compromised.

Current dressings are also unstable, which increases the chance of rebleeding due to movement. The next generation of advanced dressings will likely incorporate plasma-coagulation factors such as fibrinogen that would directly form fibrin clots and seal injured vessels. Hemostasis would be independent of a person’s injuries, and re-bleeding would be less likely also.

St. Teresa Medical, Inc., a medical device company in Minnesota, is commercializing this kind of hemostatic technology platform called FASTCLOT®. The patent-pending FASTCLOT products use an electrospun nano-fiber dextran matrix carrier along with fibrin producing proteins such as thrombin and fibrinogen. The carrier in all FASTCLOT products dissolves in seconds to minutes when in contact with fluid, effectively releasing the clot forming proteins at the bleeding site. As a result, the clotting cascade is accelerated, generating a quick and robust clot in both arterial and venous bleeding, preventing excess blood loss. Most importantly, the FASTCLOT platform technology is the only completely dissolvable and absorbable fibrin sealant that will be available in the market. As opposed to other fibrin sealants, FASTCLOT products leave nothing behind in the patient’s body, eliminating the risk for scarring, inflammation and re operative surgery.

The FASTCLOT technology was developed by a research team at Virginia Commonwealth University and is exclusively licensed by St Teresa Medical. The company is developing products for both surgery (SURGICLOT®) and trauma (WRAPCLOT®), for civilian and military markets. St. Teresa Medical also owns a subsidiary, St. Francis Veterinary Medical, where the product ANIMALCLOT® designed for animal use and developed using the same FASTCLOT technology is currently being sold.

Fibrin dressings have great life-saving potential but their use is limited by availability, cost and safety. CEO and co-founder Phil Messina said St Teresa Medical products can overcome these limitations. St Teresa has completed several pre-clinical animal studies demonstrating the safety and efficacy of the technology. All studies indicated no allergic, immunogenic or thrombolytic events. The FASTCLOT products are reliable, robust and inexpensive hemostatic agents, Messina said.

“We create value for the patient, surgeon, hospital and payer delivering better clinical outcomes,” he said.

St. Teresa Medical products have an estimated global market potential of several billion dollars. Surgical applications represent the single largest market. The company has raised up to $4 million since its inception. St Teresa Medical expects a CE Mark approval on its SURGICLOT fibrin sealant in mid 2014 in Europe and subsequent approval in the US through a Biologics License Application (BLA) submission approximately 18 months later.

Cohera Medical, Inc.® Successfully Completes Clinical Trial and Confirms Safety of Sylys® Surgical Sealant

PITTSBURGHDec. 10, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has successfully completed a clinical trial confirming the safety of Sylys®Surgical Sealant designed to significantly reduce anastomotic leakage in intestinal procedures. The European study included patients enrolled at two sites in the Netherlands.
Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur.
"Sylys enhances standard closure techniques, advancing the healing process and reducing post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "With the completion of this study, we are a step closer to providing patients with the best opportunity for a successful outcome following intestinal anastomosis procedures."
On average, anastomotic leaks occur in 3-15% of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1-4B market.