Auto-Immune/Inflammatory Diseases and Other

Pipeline Table:

Project / Compound	Potential Indication	Clinical Phase
Debrase®(partner -MediWound Ltd.)	Removal of burn-injured tissue (eschar)	III (in Europe)
Diapep-277 (partner - Andromeda Biotech Ltd.)	Type I diabetes	III
Laquinimod	Crohn's Disease Lupus Nephritis	II II

Mediwound Ltd's Phase II/III Product: Debrase® Gel Dressing (DGD) for Burns

MediWound Ltd. is a biotechnology niche specialty company.
Established in 2001, MediWound is committed to develop, manufacture & commercialize global "added value" innovative products to address unmet needs in the fields of burn and wound management.
Medowound's product Debrase® Gel Dressing (DGD) is an innovative product consists off a mixture of proteolytic and used for the debridement of burn wounds. DGD dissolves the eschar within 4 hours of treatment providing an effective, selective, fast and safe alternative to current debriding means, such as surgery or non-surgical methods.

DGD Burn Treatment Benefits :

Selective and effective - In most cases, following a 4 hour application of DGD, >90% of the treated area is debrided. DGD will debride only the dead burn eschar without harming the vital dermis and epithelium that are essential for spontaneous healing of the burn wound. Therefore, treatment with DGD results in overall less area grafter and skin harvested from healthy donor sites.

Fast and non-traumatic debridement at patient bed - As a first line therapy, DGD can be applied within hours of admission regardless of burn degree diagnosis. A complete debridement of the burn wound can be achieved within the first 24 hours post admission. This procedure does not require special operating room facilities or personnel. Treatment with DGD is simple to perform and does not involve the risks associated with surgery (such as trauma, blood loss, and effects of general anesthesia).

Enables accurate diagnosis - The presence of the opaque eschar at the burn wound site does not permit accurate diagnosis of the wound's depth. DGD, by its selective and tissue sparing activity, exposes the various depths of the clean burn wound allowing early and accurate diagnosis of the various wound depths, followed by educated planning for the future treatment strategy.

Debridement of special areas - Burns of the face, hands and feet involve special risks and demands. Selective, early non-surgical debridement of hand burns with DGD provides a clean wound bed early in the treatment process. DGD facilitates preservation of all the viable tissues and structures in the delicate and anatomically crowded hand. These structures are at risk in non selective, traumatic surgery or in the slow non-surgical procedures. Early adequate care of the clean bed will offer an optimal wound healing process and good long term esthetic and functional results

Mediwound's Initial clinical experience is based on a retrospective, non-comparative, clinical trial of 154 patients with 401 wounds, adults and children, with deep second and third degree burns.

With DGD, debridement was achieved in 86.5 � 22% of the intended area.
Only 42.7% of the wounds were grafted. Mostly 3rd degree burns.
Of those, only 20.5% were excised prior to grafting.
Mean time to wound closure was 22.9 days.

Mediowund is currently conducting Phase II and III trials in a number of burn centers in the US and the EC.

Andromeda's Phase III Studies: DiaPep277 for type 1 diabetes (T1D)

Founded in 2007, Andromeda Biotech is focused on the development of innovative treatment for autoimmune diabetes. The Company's lead product, DiaPep277, currently in phase III clinical trials, is a novel therapeutic approach for treating type 1 diabetes (T1D). It is a unique peptide derived from the human protein, HSP60, which immunomodulates the immune system, prevents the destruction of pancreatic cells that secrete insulin, and preserves their natural function.

To date, there is no therapy that can prevent the destruction of insulin secreting beta cells. DiaPep277 is designed to treat type 1 diabetes patients with residual insulin secreting cells. Target populations include newly diagnosed adult patients, type 1 diabetic children, people with high risk to develop type 1 diabetes, and type 1 diabetes patients with slow progressing disease.

DiaPep277® is a synthetic peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide modulates the immune system that leads to autoimmune diabetes by diminishing or blocking the destruction of beta cells by the immune system. Treatment of type 1 diabetes patients with DiaPep277® may have several medical benefits including prevention of deterioration of disease, improved metabolic control, reduction of diabetic complications and reduction of daily insulin dose requirements.

Andromeda, owned by Clal Biotechnology Industries (90%) and Teva Pharmaceutical Industries (10%), running a phase III clinical study in 40 medical centers in Europe, Israel, and South Africa.

Laquinimod for Crohn's Disease and Lupus Nephritis

In addition to the efficacy shown in Phase II clinical trials related to MS, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Laquinimod is currently in Phase II development for Crohn's disease and Teva expects to initiate the clinical development of the compound for Lupus Nephritis in the near future.