Alafair Biosciences develops cross-linked polysaccharide hydrogel films to addres

描述（由申请人提供）：这个STTR项目的目标是开发一种预先形成的、天然的水凝胶术后粘连屏障，具有改进的处理特性、腹腔镜分娩能力和一致的疗效。我们的技术是基于一种新颖的专利工艺，赋予通常脆，弱材料非凡的弹性和韧性。术后粘连给公众健康带来了沉重的负担。每年用于粘连相关并发症的住院费用为34.5亿美元。尽管为解决这种不想要的疤痕形成做出了巨大的努力，但目前还没有一致有效和安全的解决方案。为了满足理想粘合屏障的标准并克服当前抗粘合技术的限制，我们提出了一种预成型屏障，它具有优异的处理性能和改进的抗粘合效果。我们的细胞膜由透明质酸（HA）和海藻酸盐组成，它们是天然多糖，用于伤口愈合和抗粘连。基于ha的抗粘附屏障已被fda监管超过14年。透明质酸在酶降解后代谢，并且通过无毒修饰，降解率可以调整。海藻酸盐为基础的伤口敷料已经被FDA监管了20多年。海藻酸盐迅速水解，随后肾脏清除。我们的薄膜采用了我们实验室开发的一种新颖的专利加工技术，使其具有弹性和韧性等机械性能。这种简单的处理方法不需要专门的或昂贵的设备，有毒成分，并且很容易扩大规模。在第一阶段，我们将优化抗粘膜的处理性能和降解可调性，并进行安全性和有效性的中试研究。这些测试的目标将是a)了解支持从预植入膜到完全生物吸收的机械行为的基础科学，以及b)确保安全有效预防粘连的可行性。在II期，我们将通过解决产品开发、监管和其他临床相关问题，为我们的技术商业化做好准备。这些问题包括保质期稳定性、体内降解率、组织粘附时间、预防的愈合机制、局部抗粘附效果和次要使用指征。最后，我们将根据FDA指南和国际标准化组织（ISO） 10993标准外包特定的生物相容性评估。在第二阶段项目结束时，我们将开发和制造最终产品，并将完成首次人体试验的所有先决条件。

DESCRIPTION (provided by applicant): The goal of this STTR project is to develop a pre-formed, naturally-based hydrogel postoperative adhesion barrier with improved handling characteristics, laparoscopic deliverability, and consistent efficacy. Our technology is based on a novel, patented process that imparts exceptional elasticity and toughness on normally brittle, weak materials. Postoperative adhesions carry a profound public health burden. An annual $3.45 billion (US) is spent in hospitalization costs associated with adhesion-related complications. Despite tremendous efforts to resolve this unwanted scar formation there exists no consistently efficacious and safe solution. To meet the criteria of an ideal adhesion barrier and to overcome current anti-adhesion technology limitations, we propose a pre-formed barrier that exhibits exceptional handling properties and improved anti- adhesive effectiveness. Our membrane consists of hyaluronic acid (HA) and alginate, natural polysaccharides well established for wound healing and anti-adhesion. HA-based anti-adhesion barriers have been FDA-regulated for over 14 years. HA is metabolized following enzymatic degradation, and with non-toxic modification, degradation rate can be tuned. Alginate-based wound dressings have been FDA- regulated for over 20 years. Alginate is quickly hydrolyzed with subsequent renal clearance. Our films utilize a novel, patented processing technology developed in our lab that enables mechanical properties such as elasticity and improved toughness in otherwise weak materials. This simple processing method does not require specialized or expensive equipment, toxic components, and is easily scaled up. In Phase I, we will optimize our anti-adhesive membrane for handling properties and degradation tunability, and perform a pilot safety and efficacy study. The goal of these tests will be to a) understand the basic science supporting the mechanical behavior from pre-implanted membrane to fully-bioabsorbed, and b) ensure feasibility of safe and effective adhesion prevention. In Phase II, we will to prepare our technology for commercialization by addressing product development, regulatory, and other clinically relevant issues. These issues include shelf-life stability, in vivo degradation rate, tisue adherence timing, healing mechanism for prevention, localized anti-adhesive efficacy, and secondary indication of use. Finally, we will outsource specific biocompatibility assessment per FDA guidance and International Organization for Standardization (ISO) 10993 standards. At the end of the Phase II program we will have developed and manufactured a final product and will have accomplished all prerequisites to initiate first in human trials. PUBLIC HEALTH RELEVANCE: The goal of this program is to develop a postoperative adhesion barrier with improved handling characteristics, laparoscopic deliverability, and consistent efficacy. The problem we address is that of post-surgical adhesions. Patients undergoing surgery have an 80% risk of developing post-surgical adhesions. Adhesions are a result of the body's natural healing process causing one or more tissues to tether to other tissues that should remain separate and freely glide past one another. $3.4 Billion dollars were spent in 2008 on hospitalizations for adhesion related illnesses annually in the US alone. The current clinical barrier options, including Genzyme's Seprafilm(R) (the leading product on the market), do not adequately address the profound public health burden that results from postoperative adhesions. Our proposed material is composed of alginate and hyaluronic acid, which are already used clinically, thus making them excellent candidate biomaterials for ultimate clinical utility. Our unique patented in situ crystallization process results in a robust, elastic, conformable and bioresorbable membrane. Ultimately, our solution will result in a significant decline in readmission for adhesion related illness, pain, suffering, reoperations, and the potential multimillion or billion dollar savings.