Rich Pharma Receives FDA Approval For A Phase 1/2 Study In AML & MDS
BEVERLY HILLS, Calif., Dec. 28, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTC Markets: RCHA) ("Rich Pharmaceuticals" or the "Company") is pleased to announce that the Company has received approval from the U.S. Food and Drug Administration (FDA) to commence its Phase 1/2 clinical for the treatment of Acute Myelocytic Leukemia (AML) and Myelodysplastic Syndrome (MDS) patients. The FDA has approved the Company's Investigational New Drug (IND) application and has approved the Company's commencement of a clinical program titled "A Phase 1/2, Evaluation of the Safety and Efficacy of RP-323 in Combination with all-trans-Retinoic Acid, Sodium Butyrate, and 1, 25-dihydroxyvitamin D3 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)". This approval gives the Company an immediate go ahead to start patient enrollment for a Phase 1/2 study using Rich Pharmaceuticals' lead compound RP-323 in clinical trials.
"This is a very exciting time at Rich Pharmaceuticals. I am pleased to announce that we have reached our most significant milestone to date," said Chief Executive Officer, Ben Chang. "Our team is enthusiastic with this development and we look forward to considerable advancement as we plan to begin clinical trials in the upcoming year."
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
Acute Myelocytic Leukemia (AML), also known as Acute Myelogenous Leukemia, is the most common acute leukemia type that affects mostly adults. AML is an aggressive form of cancer of the blood and the bone marrow, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal white blood cells. In the U.S., over 20,000 new cases of AML are diagnosed annually.
Myelodysplastic Syndrome (MDS) occurs when the blood-forming cells in the bone marrow are damaged which leads to low numbers of one or more types of blood cells. In MDS, some of the cells in the bone marrow are damaged and have problems making new blood cells. Many of the blood cells that are made by these damaged cells are not normal. The abnormal blood cells die sooner than normal cells, leaving the person without enough normal blood cells and with low blood counts. MDS can turn into a fast-growing cancer of bone marrow cells called acute myelocytic leukemia and occurs in about 1 out of 3 people with MDS.
For more information about AML see for example:
http://www.cancer.gov/cancertopics/pdq/treatment/adultAML/Patient/page1
http://www.cancer.org/cancer/leukemia-acutemyeloidaml/
For more information about Hodgkin's Lymphoma see for example:
http://www.cancer.gov/cancertopics/types/hodgkin
http://www.cancer.org/cancer/hodgkindisease/
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.
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SOURCE Rich Pharmaceuticals, Inc.
