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Promore Pharma enters Phase III clinical collaboration

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Promore Pharma and Cellastra, a clinical stage developer of pharmaceutical assets, has announced the signing of a term sheet, towards a strategic collaboration for the Phase III clinical development of PXL01 and subsequent registration and marketing in the US and Canada.

“This co-development initiative for PXL01 in the US market is pivotal to our strategic approach and Cellastra is an ideal partner for us,” said Jonas Ekblom, President of Promore Pharma, “Together we will deploy our combined development capabilities and networks to expedite the development of this first-in-class pharmaceutical product for the North American market.”

The collaboration will target a first indication of prevention of post-surgical adhesions after tendon- and nerve-repair procedures in the hand, arm and foot.Adhesions frequently occur during the healing process, when scar tissue forms and connects tendons to the surrounding tendon sheath, thereby impeding normal tendon function.

Adhesions are common to all invasive surgical procedures, in particular after tendon injuries in the hand. Hand injuries usually affect young, active and otherwise healthy people and are often caused by sports or recreational injuries or work-related accidents. These adhesions tend to cause reduced mobility and difficulties performing everyday work task and recreational activities that involve fine motor skills such as the use of machinery, computers, playing instruments and sports. The result may be a substantial and permanent impairment of quality of life. An estimated target market of more than 350,000 tendon and nerve repair procedures with a high risk of incapacitating post-surgical adhesions/scars are conducted annually in North America. There are no pharmaceutical products available on the market to prevent adhesions and scars.

“PXL01 is an advanced clinical-stage asset with a perfect fit for Cellastra’s strategy around first- and best-in class products for tissue repair and wound healing – the treatment focus-area where our US development expertise can be leveraged optimally,” commented Karl Mettinger, co-founder, President and CEO, Cellastra Inc.

“PXL01 addresses the large unmet medical need that exists because 30-50 percent of sports and many work and home activity injuries involve tendons, all with substantial quality of life consequences and substantial cost of health care,” said Professor Christopher H. Evans, Rochester, Maurice Müller Professor of Orthopaedic Surgery Emeritus, Harvard Medical School. He is a new member of the Cellastra Scientific Advisory Board and senior author of a recent review publication of new treatment modalities for tendon repair2.

Deal terms of the collaboration have not been disclosed.