LOS ANGELES, CA – 23 May, 2016 – Good results without adverse effects reported by doctors and ALS patients.
Since June 2015, Genervon Biopharmaceuticals has been providing GM604 to individual ALS patients in five countries across five continents under their government health agencies’ special access schemes. This follows the successful Phase 2A placebo controlled randomized double-blind trial of GM604 that was conducted in the USA in 2014.
Genervon acknowledges that these treatments are not conducted with the scientific rigor of a clinical trial in the U.S. These are not randomized double-blind trials, there is no placebo group, and a much wider range of ALS patients have been treated than would be accepted in a clinical trial. However, observations are being recorded by physicians before, during and after treatment, and there is a very high degree of consistency in the reports we received from doctors and patients using GM604:
1. No adverse effects have been reported in any of the international patients treated with GM604.
2. In all cases, doctors noted that treatment with GM604 coincided with a period of slower ALS disease progression or no discernable progression in the patients. In some cases, reversals in ALS disease progression have been recorded during, and in the four weeks after treatment.
3. Doctors documented patients’ responses and/or improvements through ALSFRS-R, FVC scores, and other clinical observation as per the treatment protocol during and after the completion of treatment.
4. These improvements are consistent with the 2014 Phase 2A trial results in that they underline our own assertion that GM604 is a promising safe and efficacious treatment for ALS.
“Providing GM604 for use by doctors to individual patients in multiple locations across many countries does present challenges, but Genervon has also been able to use this process to refine its treatment protocols for this heterogeneous disease,” said Dorothy Ko.
Genervon is in the early stages of planning for Phase 3 trials. However Genervon remains absolutely committed to finding a faster way of demonstrating the safety and effectiveness of GM604 and getting it to ALS patients who simply can’t wait-out the three to five years needed for Phase 3 trials. Three to five years would deny an entire ALS generation around the world the possibility of benefitting from this promising treatment.”
An updated case report document of comments from patients and doctors can be seen via this link: http://www.genervon.com/genervon/PR20160519.php
Distributed by Press Release Jet
Company Name: Genervon Biopharmaceuticals LLC
Contact Person: Emily Wang
Country: United States