Rexgenero Presents Update on Phase III Clinical Trials with REX-001, a Cell-based Therapy for Critical Limb Ischaemia

April 24, 2019 Off By BusinessWire

At the Alliance for Regenerative Medicine’s Cell and Gene Therapy
‘Meeting on the Med’ in Barcelona

LONDON–(BUSINESS WIRE)–Rexgenero, a regenerative medicine company pioneering the development of
advanced cell-based therapies to treat critical limb ischaemia (CLI),
today presented an update on its two Phase III SALAMANDER trials being
conducted across Europe for its lead development programme REX-001 to
treat CLI in patients with diabetes.

During Rexgenero’s presentation at the Cell and Gene Therapy Meeting on
the Med in Barcelona, organised by the Alliance for Regenerative
Medicine (ARM), Joe Dupere, CEO provided an update on the Phase III
programme with REX-001. Twelve of the 25 planned trial sites are now
open and treating patients in Spain, Austria, Portugal, Poland, Czech
Republic, and Hungary, with additional hospitals expected to be
initiated by the end of the year in three additional countries.

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 planning to treat 138 patients
in two Phase III SALAMANDER trials. The presentation highlighted
encouraging clinical improvements in two patients treated in Spain with
REX-001 out of protocol, as they did not meet the trial criteria.

CLI is a chronic condition and the most serious form of PAD, in which a
build-up of fatty deposits in the arteries restricts blood supply to leg
muscles. CLI is characterized by chronic ischemic at-rest pain, ulcers,
or gangrene in one or both legs. The condition represents an area of
high unmet medical need with very limited treatment options currently on
the market, highlighting the importance of Rexgenero’s pipeline of
clinical candidates.

Joe Dupere, CEO of Rexgenero commented, “We are at a hugely
exciting time for the company and, more importantly, for patients with
CLI, as our Phase III trial sites for REX-001 are now treating patients
in many countries including Spain. With our Spanish heritage, the
location of ARM’s Meeting on the Med is particularly significant for
Rexgenero. We are on track to open further clinical trial sites across
Europe.”

Rexgenero was incorporated in 2015 to progress therapies developed by
the Andalusian Health Authority – the government-run health system for
the autonomous community of Andalusia – and the Andalusian Initiative of
Advanced Therapies. Rexgenero has expanded with the headquarters now in
London, UK, but retaining R&D and manufacturing operations in Seville
(Spain) as well as manufacturing in Frankfurt (Germany). Spain is a
world leader in advanced stem cell therapies and has invested hundreds
of millions of euros into the industry.

Rexgenero benefits from its close association with the clinical and cell
therapy communities in Spain. The Phase
III SALAMANDER trials are open in Spain and are actively recruiting
patients in Cordoba, Cadiz, Badalona and Barcelona.

The Phase III SALAMANDER trials use a highly innovative trial design
with novel primary endpoints that increase the sensitivity of the study
and increase likelihood of success.

– ENDS –

Alliance for Regenerative Medicine (ARM) Cell and Gene Therapy
‘Meeting on the Med’

ARM’s Meeting on the Med is a highlight on the Cell & Gene Therapy
conference calendar, bringing together company executives, investors,
patient advocates and large pharma representatives for expert-led
panels, in-depth keynote speeches, interactive fireside chats, and over
fifty presentations by leading publicly traded and privately held
companies from around the globe.

For more information, please visit www.meetingonthemed.com.

About Rexgenero

Rexgenero is a clinical-stage regenerative medicine company developing
innovative cell-based therapies targeting serious diseases with unmet
medical needs.

The Company’s lead candidate REX-001, is a highly innovative autologous
cell therapy that is being studied in a Phase III clinical programme in
patients with critical limb ischemia (CLI) with diabetes, a poorly
treated disease with a high risk of amputation and death. REX-001 has
been shown to be effective in Phase I/II and Phase II trials,
alleviating CLI in the majority of patients, offering the potential to
increase the quality of life of CLI patients by reducing pain,
alleviating ulcers, increasing mobility, improving sleep and reducing
the need for amputation. Rexgenero is developing REX-001 in a range of
indications and, pending approval, intends to launch and market this
specialty product in major territories.

Rexgenero is a privately-owned company, which draws on an exceptional
understanding of the fundamental science of cell therapies developed by
the Andalusian Health Authority (Servicio Andaluz de Salud) and
Andalusian Initiative of Advanced Therapies.

The Company was founded in 2015 and is headquartered in London (UK) with
R&D and manufacturing operations in Seville (Spain) and Frankfurt
(Germany).

For more information, please visit www.rexgenero.com.