Rich Pharmaceuticals selects clinical site, CRO for Ph I/II trial
CMIC is an Asian pharmaceutical service provider headquartered in Japan with operations in China, Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand, Vietnam.
The study, which is for the treatment of Acute Myelocytic Leukemia (AML) in refractory patients, will be conducted in cooperation with investigators at Phramongkutklao Hospital in Bangkok, Thailand.
According to the company, the site has been cleared following a site selection visit.
Additionally, both companies are preparing submission packages for the hospital’s internal review board (IRB) and the Thailand Food and Drug Administration.
“The Company has purchased product liability insurance, the package is near completion and we hope to submit in the coming days,” Ben Chang, Rich Pharmaceuticals CEO said in the press release.
The company’s lead candidate, RP-323, is being developed for the treatment of blood and cancer-related diseases.
In March 2015, the biopharmaceutical company contracted the CRO Theradex Systems, Inc. to manage its Phase I/II clinical trial in the US.
"We selected Theradex to manage our clinical sites in the United States, due to Theradex’s invaluable assistance in finalizing the Investigational New Drug Application (IND #124642) with the U.S. FDA for Rich’s lead drug RP-323 in patients with AML,” Chang said at the time.
Rich Pharmaceuticals has not responded to a request for comment.
