News and Media

Rexgenero, a regenerative medicine company pioneering the development of advanced cell-based therapies to treat chronic limb-threatening ischemia (CLI), announces today that it will present at the upcoming Solebury Trout Private Company Showcase in New York City, USA, on 18 October 2019.

The annual Solebury Trout Private Company Showcase, now in its fifth year, features presentations and panel sessions from a select number of privately held biotech companies from around the globe.

Joe Dupere, CEO, will present the Rexgenero investment opportunity to an audience of US investors focused on growth-stage private, emerging biotech companies, including an update on REX-001, Rexgenero’s lead clinical candidate for CLI, and the associated Phase III SALAMANDER clinical trials.

Joe Dupere, CEO of Rexgenero commented, “With our manufacturing bases in Europe up and running, and Phase III clinical trial sites ongoing and opening across multiple countries in Europe, our ambition is to expand our reach into the USA and build relationships within the US investor community. We believe our autologous cell-based product, coupled with promising Phase I/II results and an adaptive Phase III clinical trial design, means we are well positioned for value growth and trial success. We aim to achieve regulatory and market approval in both Europe and the US over the coming years and are keen to establish new investor relationships to support our goals and help bring life-changing treatments to patients.”

Rexgenero’s presentation will take place in Presentation Room 2 at 16:20 pm (local time), 18 October 2019.

Chronic limb-threatening ischemia
CLI is the most serious form of peripheral arterial disease and is characterized by chronic ischemic at-rest pain, ulcers or gangrene in one or both legs. The condition affects an estimated 3–4 million patients in the US and Europe and represents an area of high unmet medical need as there are currently no approved therapies that successfully treat the CLI patient population.

The existing state-of-the-art minimally invasive surgical procedures and reconstruction techniques typically used fail to address the full complexity of the disease, with many CLI patients undergoing amputation as the disease progresses, highlighting the importance and market opportunity presented by Rexgenero’s advanced clinical candidate.

REX-001 and the Phase III SALAMANDER clinical trials
REX-001 consists of bone-marrow-derived white blood cells extracted from the patient (autologous) and has shown efficacy in 80% of patients in Phase II and I/II studies.

Rexgenero is in the process of treating a total of 138 patients with CLI and diabetes in two pivotal, placebo-controlled, double-blind and adaptive Phase III clinical trials (dubbed the ‘SALAMANDER’ clinical trials) at approximately 30 sites across Europe.

The clinical trials use a highly innovative and adaptive trial design with novel primary endpoints that increase the sensitivity of the study and increase the likelihood of REX-001 succeeding as a breakthrough treatment for CLI.