Rich Pharmaceuticals Retains Theradex Systems To Finalize Investigational New Drug Application And Initiate Next Phases Of Clinical Trials
BEVERLY HILLS, Calif., Oct. 7, 2015 /PRNewswire/ -- Rich Pharmaceuticals, Inc. (OTCPK: RCHA) ("Rich" or the "Company") announced today it has entered into an agreement with Theradex Systems, Inc. ("Theradex"), a leading global contract research organization ("CRO") with extensive expertise in oncology clinical development. Through this new partnership, Theradex will lead the Company 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.
"We selected Theradex to take over CRO duties for RP-323 development in AML because of Theradex's proven excellence in oncology clinical research and their reliability working in conjunction with the FDA in drug development and the FDA approval process." said Ben Chang, CEO of Rich. "After our most recent discussion with the FDA, we believe we now have clear direction for finalizing the IND, and we are optimistic that we will be able to move into clinical trials in 2016. The expansion of our team, through our collaboration with Theradex, should allow us to advance the RP-323 program as efficiently and quickly as possible and is expected to help Rich take the last step needed to fulfill the FDA's final requirements."
Rich Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative therapies in oncology, with initial concentration in treating AML, Myelodysplastic Syndromes (MDS) and Hodgkin's Lymphoma. The lead "platform drug" (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. TPA induces PKC to produce NF kappa, which produces NF kappa B that has the ability to regulate cellular responses by entering into the nucleus of cell. 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.
Acute Myelocytic Leukemia (AML), also known as acute myelogenous leukemia, is the most common acute leukemia type that affects 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., about 18,000 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 myeloid leukemia and occurs in about 1 out of 3 people with MDS.
Hodgkin's lymphoma is a cancer that is found most frequently in two different age groups: 15 – 35 and over 55, and occurs in both sexes although it is more common in males and individuals with HIV. Malignant Reed Sternberg cells invade and destroy the architecture of the lymph nodes and infiltrate major organs such as the liver and spleen. Radiation and chemotherapy are used routinely but these treatments can later result in morbidity and mortality as a result of causing second malignancies. In the U.S., over 100,000 people suffer from Hodgkin's lymphoma.
About Rich Pharmaceuticals:
Rich Pharmaceuticals, Inc. (OTCPK: RCHA) is a biopharmaceutical company developing a treatment for Acute Myelocytic Leukemia (AML), Myelodysplastic Syndromes (MDS), and Hodgkin's Lymphoma. 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.
About Theradex Systems, Inc.:
Theradex Systems, Inc. is an international contract research organization providing complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases. Theradex conducts studies that lead to marketing approval of significant medical advances; and has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfills all regulatory requirements. Theradex's expertise is also available to assist client personnel in expedited development planning and execution. Find out more at www.theradex.com
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 MDS see for example:
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 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
Logo - http://photos.prnewswire.com/prnh/20151006/274760LOGO
SOURCE Rich Pharmaceuticals, Inc.
Related Links
http://www.richpharmaceuticals.com
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article