MONTREAL, Sept. 11 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE), a Montreal-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, and to 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 severity of 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's fibrin 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 to apply 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. The previous study, conducted in April 2008, also demonstrated that the use of Haemacure's fibrin sealant resulted in a statistically significant reduction in 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 study used 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 timely manner", 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 to US$150-$200 million in fibrin sealant sales.
Haemacure Corporation is a specialty biotherapeutics company developing high-value human plasma-derived protein products for commercialization. Haemacure's research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical haemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. Haemacure has identifie