Delivery of certain drugs in a fibrin sealant

ZURICH, Switzerland & WOBURN, Mass., Sep 23, 2008 (BUSINESS WIRE) -- Kuros Biosurgery AG and Aeris Therapeutics, Inc., both privately held biotech companies, announced today that Kuros has granted Aeris an exclusive license in the field of lung volume reduction to certain patent rights Kuros exclusively licensed from the American Red Cross that cover the delivery of certain drugs in a fibrin sealant. In return for the license, Kuros will receive upfronts, milestones and royalties on the sale of Aeris' lead product, the AeriSeal(TM) Biologic Lung Volume Reduction (BLVR) System, a novel investigational emphysema treatment. Aeris is currently preparing for the initiation of Phase 3 clinical trials for the AeriSeal BLVR system.
Commenting on the license, Dr. David Dove, CEO of Aeris, said: "The licensing of this IP from Kuros is an important step in the continued development of our unique Biologic Lung Volume Reduction System. We believe that BLVR has the potential to offer patients suffering from emphysema a treatment option that can alleviate their symptoms of shortness of breath and improve quality of life."
The AeriSeal Biologic Lung Volume Reduction System is a non-surgical treatment in which a bronchoscope is used to deliver a proprietary mixture of drugs and biologics that form a bio-absorbable gel to diseased areas of the lungs. The gel is composed of a mixture of a fibrin sealant as a drug delivery system, an antibiotic to prevent infection and drugs designed to cause a reaction in targeted areas of the lungs. A unique element of the BLVR System is its use of the body's natural scar formation response to permanently collapse diseased areas of the lungs. This reduction in lung volume allows the less diseased parts of the lungs to function more effectively and thereby improves the breathing of patients with emphysema.

Omrix Biopharmaceuticals Completes Enrollment of Initial 90 Patients Needed to Conduct Interim Analysis in Fibrin Pad U.S.

Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.
The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
About the Fibrin Pad
The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

TraumaCure Receives CE Mark Clearance to Sell WoundStat in Europe

TraumaCure Inc. announced today that its ground-breaking hemostatic agent, WoundStat™, has received CE Mark approval, clearing the way for sales in the European Union and all countries recognizing the CE Mark. CE Mark approval from the European Union certifies WoundStat has met health, safety and environmental requirements for consumer safety.

Neose selling out to Novo Nordisk, BioGenerix

Neose Technologies Inc. reached agreements Thursday to sell its assets to two foreign drug company collaboration partners for about $43 million.
The struggling Horsham, Pa., biopharmaceutical company stock was trading at 23 cents a share when the deals with Novo Nordisk of Denmark and BioGenerix of Germany were signed.
The asset sales are the initial step in a contemplated liquidation of Neose.
Neose (NASDAQ:NTEC), which specializies in using its enzyme pegylation technology to remodel molecules and develop next-generation therapeutic proteins, has been working with BioGenerix on a treatment for chemotherapy-induced neutropenia (which causes a drop in infection-fighting white blood cells), and with Novo Nordisk on an improved hemostasis compound to inhibit bleeding.
Under the terms of the deal, Neose is retaining certain intellectual property rights, including those related to producing glycolipids, for “future disposition.”

ProFibrix Expands Management Team and Opens US Subsidiary

ProFibrix B.V., a Dutch biotech company focused on products to stop bleeding and initiate tissue repair, today announced that it has added Jan Ohrstrom, MD as COO to its Executive Management team. Dr. Ohrstrom was previously part of the Senior Management team that took ZymoGenetics Inc public, and played a key role in bringing Recombinant Human Thrombin to the US market. Dr. Ohrstrom will be based in Seattle, WA, where ProFibrix has established a wholly owned subsidiary. ProFibrix Inc. will facilitate the preparations of a global pivotal Phase II/III trial for the lead product FibrocapsTM, to be conducted in 2009/2010. Additionally, the subsidiary will allow ProFibrix significantly greater access to US pool of investors.
Dr. Jaap Koopman, Founder and CEO of ProFibrix said: "We are delighted with the decision of Dr. Ohrstrom to join ProFibrix. His extensive expertise in the management of drug development and business operations will be a tremendous asset to ProFibrix as we continue to move our products through clinical development towards commercialization and prepare for the next financing round early next year."
Dr. Jan Ohrstrom commented: "Joining the team at ProFibrix was a logical step, I have known the company for a number of years, assessed the FibrocapsTM technology and found it an excellent platform with several product opportunities. Within the field of haemostasis recombinant Fibrinogen could become the next big breakthrough, and ProFibrix is well positioned to bring this novel therapeutic protein successfully to patients. Our office in Seattle will expand the company's reach into additional drug development expertise and at the same time provide easy access to US investors for the follow-up financing of ProFibrix.
It's an exciting time for us to open ProFibrix Inc."

KGI Professor Ian Phillips Awarded Defense Grants for Medical Combat Research

CLAREMONT, Calif., Sept 17, 2008 /PRNewswire via COMTEX/ -- Keck Graduate Institute (KGI) today announced that Ian Phillips, PhD, KGI's Norris Professor of Applied Life Sciences, has received two grants from the US Department of Defense (DoD) in support of his medical research to reduce battlefield fatalities among American military personnel.
"With battlefield injuries, soldiers can bleed to death before medics are able to reach them," said Phillips. "We are working to produce an automatic anti-hemorrhaging system that would allow a wounded soldier's own body to produce a blood-clotting protein, thus giving him or her potentially life-saving minutes until their injuries can be treated."
The anti-hemorrhaging system, known as the Automatic Hemostat Vector, would be given as an injection to soldiers before going into battle. Phillips research is focusing on a molecule that "switches on" a gene to produce a blood clotting protein, Factor VII.
When a blood vessel is broken, the bleeding reduces oxygen. Low oxygen would activate the Hemostat causing Factor VII to be made in the injured tissue. Factor VII seals broken blood vessels, and as oxygen levels are restored, the Hemostat would turn off automatically in the body.
In addition to helping soldiers, the Hemostat has potential for use in civilian surgery and cases of hemophilia and hemorrhagic stroke. Phillips is also working on ways to add a stem cell homing factor gene to the Hemostat system that would cause stem cells to be drawn to the injury from bone marrow and begin healing the wound even while the injured soldier is on the battlefield.
Phillips' research is funded by a sub-grant from the DoD's Defense Threat Reduction Agency and the US Army's Telemedicine and Advanced Technologies Research Center to the University of South Florida. To date, Phillips has received $323,000 from the Defense Department in support of his research.
The Hemostat system will be developed at KGI and tested at the University of South Florida and the US Army Surgical Institute in San Antonio.
Phillips holds a MERIT Award from the National Institutes of Health, the 2002 Christopher Columbus Award for science and technology and the Lucian Award for research on circulatory disease.

CryoLife Expands Distribution of Hemostase MPH(R) to France through Laboratoire Gamida

CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that it has begun distribution in France, through Laboratoire Gamida, of Hemostase MPH for use in general, cardiac and vascular surgery.
CryoLife began distributing Hemostase MPH in the U.S., the United Kingdom and Germany in the second quarter of 2008. Distribution in other markets outside the U.S. is planned for later in 2008 and in 2009.
Hemostase MPH is developed using Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this hemostatic or antibleeding agent facilitates the formation of a resilient, natural clot within just a few minutes. Hemostase MPH received CE Mark approval in 2003 and FDA pre-market approval in September 2006.
Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional operating room preparation or special storage conditions. In addition, pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks or more to fully break down.
"As a complement to CryoLife's BioGlue(R) product line, Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, and we are pleased to begin offering this product in France," stated Steven G. Anderson, president and chief executive officer. "We will showcase Hemostase MPH at the European Association of Cardiothoracic Surgeons meeting in Lisbon, Portugal later this week."

TraumaCure Receives Health Canada Licensure

TraumaCure Inc. today announced that Health Canada has issued a medical device license for WoundStat™, a ground-breaking hemostatic agent for control of bleeding in high-pressure arterial wounds. The availability of WoundStat in Canada enables military, emergency medical services, law enforcement services, rescue services, and other first responders to stop arterial bleeding within seconds and stabilize an injured person, giving the time needed to seek advanced medical help and save lives.
TraumaCure also announced an exclusive distributor agreement with Canadian Tactical and Operational Medical Solutions Inc. (CTOMS), the highly regarded provider of Combat Casualty Care training and supplier of high quality medical equipment, to make WoundStat immediately available throughout Canada. CTOMS is based in Edmonton, Alberta

Haemacure Confirms Effectiveness of its Fibrin Sealant in Second Preclinical Study

Haemacure Corporation (TSX : HAE), aMontreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, disclosed today the positive results of a second preclinical study conducted on the use of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN,in preventing the formation of post-surgical adhesions in a bleeding surgical model. The study compared Haemacure's fibrin sealant to untreated controls, andto two major FDA-approved adhesion prevention products: Interceed(TM)Absorbable Adhesion Barrier (Ethicon) and Seprafilm(R) Adhesion Barrier(Genzyme). Use of Haemacure's fibrin sealant in the presence of blood resulted in a statistically significant reduction in the incidence, extent and severityof adhesions, as compared to the untreated control group. Haemacure's fibrin sealant also was statistically significantly more effective than both Interceed and Seprafilm. For example, the extent of adhesions in both the untreated and Seprafilm groups was three times (54.2%) that in the Haemacure'sfibrin sealant group (18%). It was even higher, four times, in the Interceed group (71.7%). Liquid fibrin sealants, such as Haemacure's, are much easier toapply to treatment sites than adhesion barriers such as Interceed. They also lend themselves to laparoscopic application much better than these types of barriers. This second study, conducted in July 2008, confirms and extends previous pre-clinical results demonstrating the effectiveness of Haemacure's fibrin sealant in adhesion prevention, using its current haemostasis formulation. Theprevious study, conducted in April 2008, also demonstrated that the use of Haemacure's fibrin sealant resulted in a statistically significant reductionin the incidence, extent and severity of adhesions, as compared to untreated controls. Both studies were designed to evaluate the efficacy of Haemacure's fibrin sealant in a rabbit uterine horn abrasion model. The previous studyused a model where bleeding was absent or minimal. "We are very excited with the results of this latest study, as it opens a new market with a significant unmet medical need and allows Haemacure to leverage its technology, past clinical data and experience in a timelymanner", said Joseph Galli, Chairman and CEO of Haemacure. The use of Haemacure's current fibrin sealant haemostasis formulation for adhesion prevention could significantly accelerate time to market for this indication, by three to five years. This reduced timeframe accelerates Haemacure's ability to address a significant unmet medical need with a potential additional indication for its fibrin sealant. Post-surgical adhesions are estimated to cost the U.S. healthcare system in excess of$2.1 billion annually. The U.S. market for adhesion prevention products in gynaecological surgery is estimated today at $100 million and could grow toUS$150-$200 million in fibrin sealant sales.

Cubist Pharmaceuticals Provides Update on Advancing Product Pipeline

Ecallantide for the prevention of bleeding in cardio-thoracic surgery:
Unmet Medical Need:
Cubist estimates that more than 650,000 patients annually undergo on-pump cardiothoracic surgery (CTS), which includes coronary artery bypass grafting (CABG) and heart valve replacement or repair procedures, in order to correct myocardial ischemia or diseased valves that cannot be treated with less invasive procedures. When a patient's blood comes into contact with the artificial surface of the cardiopulmonary bypass (CPB) machine and tubing, serious complications can result, including the systemic inflammatory response syndrome (SIRS), a whole body inflammatory state that compromises heart and lung function in already fragile patients. Blood loss also occurs as a result of this major surgery and can be exacerbated by SIRS. Aprotinin, an agent previously approved and marketed for the reduction of blood loss during on-pump surgery, was withdrawn from the market in 2008, creating a large unmet medical need.
Key Scientific/Clinical Data:
In a proof of concept study of ecallantide for the reduction of blood loss in CTS conducted by Dyax Corp, from whom Cubist obtained the rights to develop and commercialize ecallantide in North America and Europe for surgical indications in April, 2008, the magnitude of the treatment benefit, approximately a 50% reduction in transfusion volume compared with placebo, was consistent with the effects of aprotinin. In clinical trials to date, ecallantide has been well tolerated in healthy subjects and in patients undergoing CTS.
Status:
Cubist’s goal is to bring ecallantide rapidly to market as a therapy to reduce bleeding in CTS. To achieve this goal, Cubist plans to advance ecallantide as quickly as possible to a Phase 3 randomized controlled clinical trial. Cubist currently is developing the protocol for a definitive dose ranging study that the company expects will represent the completion of Phase 2 development.
Upcoming Milestones: Cubist plans to initiate a Phase 2 dose-ranging study year-end 2008.