BEVERLY HILLS, Calif., Sept. 27, 2016 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTC Markets: RCHA) ("Rich Pharmaceuticals" or the "Company"), a biopharmaceutical company focused on developing and commercializing innovative therapies in oncology, announced today several of the milestones it had reached during the past quarter, and those that it intends to pursue in the upcoming quarters.
Rich Pharmaceuticals has:
- Received clearance from the U.S. Food and Drug Administration (FDA) to commence its Phase 1/2 clinical trials for the treatment of Acute Myelocytic Leukemia (AML) and Myelodysplastic Syndrome (MDS) patients.
- Submitted full clinical package to a major Southeast US University Medical school to conduct the AML study. The package is currently in review with the University's Scientific Review Board (SRB) and Institutional Review Board (IRB).
- Submitted full clinical package to a major Thailand medical center to conduct the AML study. The package is currently in review with the Center's Scientific Review Board (SRB) and Institutional Review Board (IRB) currently, in review with SRB and IRB.
- Retained the services of an Asian Contract Research Organization ("CRO"), CMIC ASIA-PACIFIC, PTE. LTD. ("CMIC"), to run Rich's upcoming Phase 1/2 clinical for the treatment of AML and MDS patients in connection with Asian Phase 1/2 clinical trials. CMIC is considered to be one of Asia's top CRO's for running clinical oncology studies.
- A protocol for Hodgkin's Lymphoma is in final review and being prepared for submission to the FDA using the company's existing Investigational New Drug (IND).
In the upcoming quarters, and subject to receiving sufficient capital, Rich intends to:
- Receive IRB approval from the US University to commence the Phase 1/2 study in the US.
- Receive IRB approval from the Thailand medical to commence the Phase 1/2 study in the Thailand.
- Enroll the first patient in US and Thailand.
- Submit the Hodgkin's Lymphoma protocol to the FDA
- Submit Hodgkin's Lymphoma clinical package to the medical Universities and medical centers in the last quarter of 2016 for SRB and IRB review.
"As warranted, but no less than once a quarter, Rich Pharmaceuticals intends to provide an update on the milestones it has reached in the previous quarter, and those it intends to pursue in the subsequent quarter(s)," said Ben Chang, CEO of Rich Pharmaceuticals. "Of course, Rich Pharmaceuticals' ability to reach any specific milestones is subject to many factors, including, but not limited to, raising sufficient capital, licensing of technology, manufacturing of the drug, availability of clinical sites and patients, and timing. As of today, we do not have the capital to fund the milestones we are pursuing, but we intend to continue to pursue the capital markets, and to seek potential licensing opportunities, to obtain the funds necessary to be able to pursue these objectives. We cannot guarantee that we will be able to obtain the necessary funds to achieve these milestones. Nevertheless, we remain optimistic that we will be able to carry out our mission to eventually develop and commercialize drugs to treat cancer and stroke in patients with the greatest unmet medical needs," continued Mr. Chang.
"We have reached these milestones with minimal funding and are extremely satisfied with the accomplishments we have achieved. The milestones we have to look forward to achieving are significant, not only for the company but for patients who suffer from AML, MDS and Hodgkin's Lymphoma," said Ben Chang, CEO. "Management remains aggressive in pursuing activities designed to unlock value over the next few quarters," continued Mr. Chang. "I believe that being in parallel studies in multiple sites and countries would strengthen the company's position."
About Rich Pharmaceuticals:
Rich Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies in oncology, with initial concentration in treating AML, 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. RP-323 is a phorbol ester, which induces differentiation and/or apoptosis in multiple cell lines and primary cells, activates protein kinase C (PKC), and modulates the activity of multiple downstream cell signaling pathways, including mitogen-activated protein kinase (MAPK) pathways. RP-323 induces PKC to produce NF kappa, which then produces NF kappa B that has the ability to regulate cellular responses by entering into the nucleus of cells. NF kappa B binds to DNA and changes the nature of the cell and (1) induces differentiation; (2) induces proliferation; (3) cytokine induction; (4) and/or apoptosis. 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 commence clinical trials and 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.
Ben Chang, CEO
9595 Wilshire Blvd., Suite 900
Beverly Hills, CA 90212
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SOURCE Rich Pharmaceuticals, Inc.