Clinical Pipeline

当社の研究開発は、加齢に伴う変性疾患のための新しい治療法の開発とオーファンドラッグに焦点を当てています。重症心不全・糖尿病壊疽・癌のT細胞治療・目の病などのBio Material・幹細胞・自己Growth factorTherapy、そして患者自身の自己Stem Cellからの自己Hiaruronsanや自己Collagenを使用した加齢予防・加齢治療などをメインに、更に世界初の自己幹細胞・自己Growth factorから製造したCosmetics製品など、世界最先端のRegenerative Medicineグループとして研究開発・臨床をめております。

 

当社がライセンス契約を取得済みのアメリカでのフェーズ3の終了した販売承認取得済み製品といたしましては2製品があります。

また、フェーズ3後半製品としては、大きなマーケットを持つ糖尿病壊疽のBio Material製品が控えています。

I-Horus Inc.およびその子会社による比較的短期の製品開発としてはす。眼科領域の角膜再生があります。これは、Placenta Sheetを使用した、Orphan Drugとしてのライセンス契約を取得済みです。

 

  

  


R & D Pipeline

By Melvin Silberklang, Ph.D.

Studies with the Bilayered Cellular Matrix, OrCel®
i-Horus Inc. scientists  have developed a new tissue-engineered wound healing product, a bilayered cellular matrix produced from allogeneic living skin cells, trademarked OrCel®. This product contains cultured donor neonatal human keratinocytes and fibroblasts in separate compartments of a bilayered collagen sponge. OrCel®ís first FDA approvals were obtained last year for treatment of acute surgical excisions, such as contracture release sites and donor sites in Epidermolysis Bullosa patients undergoing hand reconstruction surgery and donor sites in burn victims undergoing excision and autografting. Since the cells used to produce Orcel® are extensively expanded in vitro, they cease to express significant levels of HLA-II antigens and, upon application to a wound bed, are apparently not immediately recognized by the recipientís immune system as foreign.

 

This has been confirmed in both clinical trial and commercial experience, as no clinical observations of signs of tissue rejection have ever been reported. In addition, in a recent pilot study with the experimental cryopreserved OrCel® product, no HLA-cytolytic antibody response to alloantigens in the product was detected in a cohort of 13 patients after four sequential weekly product applications. Resorption appears to take place gradually, with no remnants of the donor cells or matrix being detectable by two weeks post-treatment. Our working hypothesis is that extracellular secretion of cytokines and growth factors by the living cells in OrCel® is a major contributing factor to the productís ability to accelerate wound healing.

 

Under in vitro culture conditions, the close keratinocyte-fibroblast proximity afforded by the matrix enhances the ability of each cell type to exert a paracrine effect on the other through extracellular diffusible factors it expresses. The composite cytokine and growth factor expression profile of a keratinocyte-fibroblast co-culture exhibits synergistic features that significantly exceed the individual contribution of either cell type when grown alone. Studies conducted by I-Horus Inc. also reveal differences between growth factor expression by OrCel® and competitive products. Interestingly, the net composite expression by OrCel® in vitro has also been found to closely resemble the net profile of secreted endogenous growth factors measured in normal clinical volunteers in vivo in acute skin wound fluid from experimental donor sites. Thus, when placed into contact with a wound bed, the product appears to be capable of supplementing the endogenous wound fluid with an exogenous supply of normally balanced growth factors characteristic of a healthy, healing acute wound.

 

Our clinical results with the treatment of donor sites demonstrate an acceleration of time to 100% healing. In the case of chronic wounds, we hypothesize that OrCel®ís balanced mixture of exogenous growth factors contributes to the activation of the patientís own local cells to resume a healing profile. Finally, a very practical feature of OrCel® is its ability to be cryopreserved and to recover full potency upon thawing. Cryopreserved OrCel® can provide a sophisticated off-the-shelf wound treatment, available on demand at point of use.

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