Rich Pharmaceuticals Inc(OTCBB:RCHA), a clinical-stage biotech firm that develops novel therapies in oncology, said that it has accomplished a GMP clinical batch of its key RP-323 trial drug. It was developed at the advanced facility of Wuxi Apptec Biopharmaceutical in Shanghai.
Rich Pharmaceuticals Inc(OTCBB:RCHA)’s new batch of its trial drug RP-323 represents a second-generation compound that has enhanced levels of usability and stability. The company developed the new batch and all regulatory testing initiatives last year. It transferred the technology to Wuxi Apptec for further processing of RP-323. Currently, the study drug is in the final testing phase at Wuxi Apptec. It is anticipated to reach clinical sites in coming month for the upcoming scheduled clinical trials.
New Drug Application
Rich Pharmaceuticals submitted Investigational New Drug Application for its Phase 2 study to assess the safety and efficacy of drug RP-323 in patients with MDS and AML in October 2014. As per the requirement of IND, Rich Pharmaceuticals Inc(OTCBB:RCHA) was required to produce sufficient quantities of drug RP-323 under GMP guidelines.
Rich Pharmaceuticals CEO, Ben Chang, said that RP-323 is a potential drug candidate of company that can prove to be an effective treatment for people suffering from AML and MDS. The study of RP-323 is going on as planned with the help of Wuxi Apptec, who is a partner in the manufacturing process of RP-323. Rich Pharmaceuticals Inc(OTCBB:RCHA) expects to get approval for its IND soon.
Rich Pharmaceuticals Inc(OTCBB:RCHA) is a leading biopharmaceuticals firm that intends to develop promising treatments for Acute Myelocytic Leukemia. AML is a problem of white blood cell elevation. It also wants to develop treatments for Hodgkin’s Lymphoma and other severe blood related diseases. The primary goal is to increase refractory patients’ life expectancy and also quality of life. Its lead product candidate, RP-323 is developed to cure blood and cancer-related diseases by using non-evasive outpatient facilities.