ReJoin for Knee Osteoarthritis用于治疗膝骨性关节炎的ReJoin疗法

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Indication: Knee Osteoarthritis (KOA)

Technology Platform: Human Adipose-Derived Mesenchymal Progenitor Cells (haMPC)

Trial Phase: Clinical Trial Phase IIb, all patients completed treatment as of August 2014

The Trial . In 2013, we completed a Phase I/IIa clinical trial, in China, for our Knee Osteoarthritis (KOA) therapy named ReJoin™ . The trial tested the safety and efficacy of intra-articular injections of autologous haMPCs in order to reduce inflammation and repair damaged joint cartilage. The 6-month follow-up clinical data showed ReJoin™ therapy to be both safe and effective.

In Q2 of 2014 we completed patient enrollment for the Phase IIb clinical trial of ReJoin™ for KOA. The multi-center study has enrolled 53 patients to participate in a randomized, single blind trial. We published 48 weeks follow-up data of Phase I/IIa on December 5, 2014. The 48 weeks data indicated that patients have reported a decrease in pain and a significant improvement in mobility and flexibility, while the clinical data shows our ReJoin™ regenerative medicine treatment to be safe. We announced interim 24 week results for ReJoin™ on March 25, 2015, which confirmed that the primary and secondary endpoints of ReJoin™ therapy groups have all improved significantly compared to their baseline. We plan to release 12 month follow-up data in late 2015.

Our ReJoin™ human adipose-derived mesenchymal progenitor cell (haMPC) therapy for KOA is an interventional therapy using proprietary device, process, culture and medium:
• Obtain adipose (fat) tissue from the patient using our CFDA approved medical device, the A-Stromal™ Kit; and
• Expand haMPCs using our proprietary culture medium (serum-free and antibiotics-free); and
• formulated for ReJoin™ therapy using our proprietary formulation.

Our process is distinguishable from sole Stromal Vascular Fraction (SVF) therapy.
The immunophenotype of our haMPCs exhibited multiple biomarkers such as CD29+, CD73+, CD90+, CD49d+, HLA-I+, HLA-DR-, Actin-, CD14-, CD34-, and CD45-. In contrast, SVF is merely a heterogeneous fraction including preadipocytes, endothelial cells, smooth muscle cells, pericytes, macrophages, fibroblasts, and adipose-derived stem cells (ASCs).

About Knee Osteoarthritis
Osteoarthritis is a degenerative disease of the joints. KOA is one of the most common types of osteoarthritis. Pathological manifestation of osteoarthritis is primarily local inflammation caused by immune response and subsequent damage of joints. Restoration of immune response and joint tissues are the objective of therapies. According to International Journal of Rheumatic Diseases, 2011, 53% of KOA patients will degenerate to the point of disability.

Conventional treatment usually involves invasive surgery with painful recovery and physical therapy. As drug-based methods of management are ineffective, the same journal estimates that some 1.5 million patients with this disability will degenerate to the point of requiring artificial joint replacement surgery every year. However, only 40,000 patients will actually be able to undergo replacement surgery, leaving the majority of patients to suffer from a life-long disability due to lack of effective treatment.

KOAprocess Our KOA therapy is not surgically invasive – it uses a small amount (30ml) of adipose tissue obtained via liposuction from the patient, which is cultured and re-injected into the patient. The injections are designed to induce the body’s secretion of growth factors promoting immune response and regulation, and regrowth of cartilage. The down-regulation of the patient’s immune response is aimed at reducing and controlling inflammation which is a central cause of KOA. We believe our proprietary method, subsequent haMPC proliferation and processing know-how will enable haMPC therapy to be a low cost and relatively safe and effective treatment for KOA. Additionally, banked haMPCs can continue to be stored for additional use in the future.

适应症: 膝骨性关节炎(KOA)

技术平台: 源于脂肪的成人间充质祖细胞(haMPC)

试验阶段: 临床试验阶段IIb,所有患者在2014年8月前完成治疗

试验

我们已经完成了KOA治疗阶段I/IIa临床试验。我们进行了为期三个月的阶段I/IIa后续追踪数据分析,显示WOMAC,NRS-11,SF-36和KSCRS膝骨性关节炎指数与基准数据相比有了大幅改善,患者膝关节疼痛得到缓解,膝关节移动和行走距离增加。经过MRI检查,发现最快在治疗三个月之后患者的软骨厚度便出现增加。我们对三位患者进行了为期六个月的后续追踪,数据证明了上述结果。在对2013年四季度最后一名患者六个月后续追踪数据进行分析后,发现患者移动性和灵活性显著改善,疼痛减少。我们已经进行了额外的研究确认软骨再生。2014年6月我们已经为阶段IIb的临床试验招募了48名患者,这些患者的治疗将在2014年8月完成。

关于膝骨性关节炎

骨性关节炎属于关节再生疾病。KOA是一种常见的骨性关节炎。骨性关节炎的病理表现主要为免疫反应造成的局部炎症,以及后续的关节损伤。治疗的主要目标是恢复免疫反应和关节组织。
根据2011年的国际风湿病杂志,最终有53%的KOA患者会出现残疾。传统治疗方式通常包括侵入式手术,以及痛苦的恢复和物理治疗。由于基于药物的疾病管理方法无效,因此该杂志预计每年大约有150万名患者最终需要进行人工关节更换手术。不过,只有四万名患者最终会进行更换手术,而大部分的患者由于缺乏有效的治疗,最后会导致终生残疾。

关于haMPC

haMPC目前被视为治疗骨性关节炎的有效疗法,拥有巨大的潜在市场。骨性关节炎是发达国家十大致残疾病之一。在全球超过60岁的男性和女性中,具有症状性骨关节炎的比例分别为9.6%和18.0%。2010年全球骨性关节炎治疗市场规模为44亿美元,预计每年复合年增长率为3.8%,到2018年将会增加至58亿美元。

为了将基于haMPC的KOA疗法推向市场,我们的市场战略为:(a)在上海和北京建立符合现行药品优良制造规范的地区实验室,并获得中国监管机构的批准;和(b)与三甲医院共同提交在临床试验环境中使用haMPC治疗KOA的申请。

KOAprocesszh

我们的KOA疗法没有手术侵入性——通过抽脂方式从患者体内获得少量(30毫升)的脂肪组织,然后进行培养,最后重新注射到患者体内。注射的作用是引发患者体内生长因子的分泌,促进患者免疫反应和调节,以及软骨再生。患者免疫反应下调的目的是减少和控制炎症,这是造成KOA的主要原因

我们认为本公司的专有方法,以及后续的haMPC增殖和加工技术能够让haMPC疗法成为低成本且相对安全并高效的KOA治疗措施。另外,储备的haMPC可以用于未来使用。