Rich Pharmaceuticals Announces Completion of the Manufacture of RP-323 Study Drug in Connection with Obtaining FDA's Final Approval of The Investigational New Drug (IND) Application For The Treatment of Acute Myelocytic Leukemia
BEVERLY HILLS, Calif., Feb. 4, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTCQB: RCHA) ("Rich" or the "Company"), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, announced today that it has competed a GMP clinical batch of RP-323 study drug that was manufactured at the state-of-the-art Wuxi Apptec Biopharmaceutical's facility based in Shanghai, China. This new batch of RP-323 represents a new second-generation compound with improved product usability and stability. Rich Pharmaceuticals developed the new formulation and all regulatory required testing methods in 2014 and transferred the proprietary technology successfully to Wuxi Apptec for the GMP production of RP-323. Currently, the new study drug is in the final examination stage at Wuxi Apptec and is expected to be shipped to clinical sites starting mid-February 2015 for the upcoming planned clinical trials.
Rich Pharmaceuticals submitted its Investigational New Drug (IND) Application for a Phase 2 multi-center study to evaluate the safety and efficacy of RP-323 in patients with AML and MDS in October 2014. In connection with the IND, Rich Pharmaceuticals was required to manufacture sufficient quantities of RP-323 under GMP.
"We believe RP-323 has best-in-class potential and holds significant promise for patients suffering from AML and MDS," said Ben Chang, Rich Pharmaceuticals' Chief Executive Officer. Mr. Chang further stated, "We are especially excited to have a partner in the manufacture of RP-323 of the high caliber of Wuxi Apptec. We expect to pursue the approval of the IND promptly and to be in clinical studies in the very near term."
About Rich Pharmaceuticals:
Rich Pharmaceuticals, Inc. (OTCQB: RCHA) is a biopharmaceutical company developing a treatment for Acute Myelocytic Leukemia (AML)/white blood cell elevation, Hodgkin's Lymphoma and other blood related diseases. Rich Pharmaceuticals' goal is to extend refractory patients life expectancy and increase quality of life. Rich Pharmaceuticals' primary development stage product candidate, RP-323, is being designed to treat blood and cancer related diseases through non-evasive outpatient facilities. Find out more at www.richpharmaceuticals.com.
Notice Regarding Forward-Looking Statements:
This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our business and product development plans, our financial projections or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to develop and commercialize products based on our technology platform, competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.
Contact:
Ben Chang, CEO
9595 Wilshire Blvd., Suite 900
Beverly Hills, CA 90212
424-230-7001 EXT 105
SOURCE Rich Pharmaceuticals, Inc.
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