'Pervasis Case Study\r'

'Pervasis Receives divest drug appellation in Europe for Vascugel® to Prevent Arteriovenous get at Failure in Patients Undergoing Hemodialysis Cell-Based Therapy Aims to decide the Body’s Healing Response, Promoting vascular Repair, Reducing the Need for Repeat working(a) Procedures and Improving Patient Outcomes Cambridge, Mass. , March 1, 2011 †Pervasis Therapeutics, Inc. proclaimed today that the European Commission (EC) has given(p) Orphan Drug Designation for Vascugel® for the cake of haemodialysis vascular overture affliction in patients with end stage nephritic disease (ESRD).The designation follows a affirmatory opinion from The Committee for Orphan medicinal Products (COMP) within the European Medicines Agency (EMA) to begin with this year. Vascugel is a novel endothelial carrell-based therapy that aims to spoil the automobile trunk’s ameliorate re unitingder following surgical interpositions to create vascular admittance which ar e necessary for ESRD patients entirelyowing hemodialysis.By promoting and enhancing vascular repair, Vascugel reduces the essential for repeat surgical interjections and improves overall patient outcomes. ESRD is an advanced and irreversible break treated mainly by hemodialysis or kidney transplantation. It is estimated that more than 250,000 ESRD patients in the EU receive hemodialysis, a blood purge therapy designed to replace vituperative kidney functions †much(prenominal) as filtering waste.Orphan Drug Designation by the EC provides regulatory and financial incentives for companies to forge and market therapies that treat a severe or chronically debilitating precedent affecting no more than quintet in 10,000 persons in the European junction (EU). In addition to a 10year terminus of marketing exclusivity in the EU after crop approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product dev elopment phase, direct access to centralize marketing authorization, as well as reductions in authoritative fees. We are move to bringing Vascugel to patients with end stage renal disease who currently must(prenominal) belong serious complications and repeat surgical procedures so they can continue to receive life-saving hemodialysis treatment,” Frederic Chereau, president and chief executive policeman of Pervasis. â€Å"Receiving Orphan Drug Designation in the EU is an important step, as it entrust help to advance the development process, and promote our ability to deliver our novel cellbased therapeutical approach to address this significant unmet aesculapian need. Vascugel has show proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access in order to undergo hemodialysis. In these trials, Vascugel exhibited an excellent safety profile, and load-bearing(a) efficacy trends were observed, including improved duration of obviousness (or unimpeded blood flow) and a stay put in time to first interpellation as compared to placebo. In 2009, Pervasis received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Vascugel in patients with ESRD. Pervasis announced weather month that the FDA had granted Fast course of action review status for Vascugel. Last year, Pervasis reached an savvy with the FDA for a Phase 3 clinical trial of Vascugel under the Agency’s Special Protocol Assessment (SPA) procedure, whereby FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking parvenu drug approval.Failure of Hemodialysis Access Points Leads to forgetful Outcomes During hemodialysis, blood is removed from the body, filtered through a dialyzer, or artificial kidney, and then returned to the body. Patients must undergo a surgical intervention to create a vascular access that enables blood to fl ow from the body to the dialyzer and back to the body. AV fistulae (created by at present joining an arteria and vein) and AV grafts (created apply a synthetic tube to join an artery and vein) are the two old types of hemodialysis access.Due to an subversive cascade triggered by surgical intervention, the vascular access much has difficulty healing, and quickly become useless or clot rapidly, prompting the need for additional, recurring surgeries to create a reinvigorated access which can lead to sevenfold complications. Up to 60 percent of all arteriovenous (AV) grafts require re-intervention after ace year. 1, 2 AV access sorrow is the most mutual reason for hospitalisation among hemodialysis patients and can lead to anemia, infection, heaviness loss, jaundice, prolonged bleeding, and other serious complications. Vascugel® †Combating hullabaloo and Promoting Healing Pervasis’ novel approach to cell therapy uses adult-differentiated allogeneic endothel ial cells (donor endothelial cells with a extremely targeted biologic function) embedded in a polymer matrix to enhance the body’s natural healing response. The endothelium is the thin social class of cells that lines the interior surface of blood vessels in the body. Endothelial cells are critical to create from raw stuff repair and health, and have a well-understood region in regulating many of the body’s healing processes, including those associated with vascular repair.Vascugel, which utilizes Pervasis’ secure endothelial cell-based course of study, is placed on the outdoor(a) of the blood vessel at the AV access site during the surgical intervention to create the access. The endothelial formulation in Vascugel secrete several factors that combat inflammation and promote proper vascular healing, cut down thrombosis (or clotting) and the formation of intimal hyperplasia, or a thickening of the blood vessel palisade in response to injury. After near four to eight weeks, Vascugel is safely resorbed by the body.Pervasis’ other areas of clinical investigation intromit improving outcomes in patients with peripheral artery disease (PAD) following surgical procedures such as percutaneous transluminal angioplasties (PTAs) with stenting, the chastenings of which result in serious complications and a significant improver in checkup costs. Earlier this year, Pervasis announced it has also embarked on an oncology development programme using its proprietary endothelial cellbased platform to prevent unwavering tumor growth, crabmeat recurrence and metastatic disease. About Pervasis Dixon et al.DAC battleground Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009; 360: 2191-2201. 2 Hayashi et al. Vascular access for hemodialysis. Nat Clin Pract Nephrol 2006; 2: 504-513 3 Castner D. Recommendations for tracking arteriovenous access complications using a charting-by-exception model. Anna Journal, 1998; 25(4): 393-396. 1 Pervasis Inc. is a clinical stage company that is create groundbreaking endothelial cellbased therapies designed to watch the body’s natural healing and repair processes in various critical therapeutic areas.The company has initially think on developing therapies to improve the outcomes of common vascular interventions, such as arteriovenous access, angioplasties, stent placements, and peripheral and coronary bypass grafts †the failure of which result in serious complications and a significant increase in medical costs. The company’s lead program, Vascugel®, has demonstrated proof of concept and safety in two Phase 2 clinical trials.Pervasis is also applying its endothelial cell-based platform applied science to develop an oncology therapy focused on preventing solid tumor growth, cancer recurrence and metastatic disease, as well as products for inflammatory disease and orthopedic injury. Pervasis is a in camera held compa ny with funding from Flagship surmisals, Polaris Venture Partners, Highland Capital Partners and the Richter Family Fund. For more information, satisfy visit www. pervasistx. com. This news release contains certain forward-looking statements that involve endangerments and uncertainties.Such statements are whole predictions and the companys actual results whitethorn differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the measure of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not meet approval to market its products. Company contact: Margaret O’Toole Pervasis Therapeutics, Inc. 617-871-1201 [email protected] com Media Contact: Liz Falcone Feinstein Kean healthcare 617-256-6622 liz. [email protected] com\r\n'