May 31, 2017 10:02am
CYTX jumps +$0.04 or +4.08% to $1.01 with 113.05 shares traded – it’s still ONLY an OPTION - something is better than ... nothing!
CYTX and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR), have executed a contract option valued at approximately $13.4 million.
- The executed option will fund the CYTX’s RELIEF trial, a U.S. pilot clinical trial of Cytori Cell Therapy™ (DCCT-10) in thermal burn injury as the next step in development of Cytori technology as a medical countermeasure for thermal burn injury. The present option increases the overall BARDA commitment to Cytori technology to approximately $34.6 million thus far.
KEY words …. Unpublished preclinical data generated by Cytori under its BARDA-funded development program indicate that intravenous delivery of Cytori Cell Therapy was associated with increased formation of new skin (epithelialization) and earlier restoration of the barrier function of the newly-formed skin1. The RELIEF trial will apply the same approach in the clinic.
“The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. Subjects will have at least one deep partial or full thickness burn wound that is to be treated with a meshed autologous split thickness skin graft (STSG). Subjects will be randomized (1:2) to receive either usual care alone or usual care supplemented with Cytori Cell Therapy.
While primarily focusing on safety and feasibility, the RELIEF trial will also assess a series of parameters related to skin graft healing. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites with study initiation expected to occur in Q4 2017.
The Bottom Line: WHY such a slow response to the upside – it’s an OPTION ?
This project with BARDA was initiated to evaluate Cytori Cell Therapy as a potential medical countermeasure that could be used to treat thousands of patients with a combination of burn and radiation injury following detonation of an improvised nuclear device in a major USA metropolitan area.
The first step towards achievement of this goal was completed in pre-clinical studies which reported that intravenous delivery of Cytori Cell Therapy improved healing of full thickness burn wounds complicated by radiation injury (linked here).
The RELIEF clinical trial represents the next step in this path. The original contract with BARDA retains two as-yet unfunded options valued at up to $68 million. The first of these options is written to support a pivotal clinical trial that could potentially follow RELIEF and lead to FDA approval of Cytori Cell Therapy