BEVERLY HILLS, Calif.,
Feb. 23, 2015 /PRNewswire/ -- Rich
Pharmaceuticals, Inc. (OTCQB: RCHA) ("Rich Pharmaceuticals" or the
"Company"), a clinical-stage biotechnology company focused on
developing innovative therapies in oncology, with initial
concentration in treating Acute Myelocytic Leukemia (AML) and
Hodgkin's Lymphoma based on its proprietary differentiation agent
RP-323,
12-O-tetradecanoylphorbol-13-acetate (TPA), highlights the
Company's 2014 significant accomplishments.
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.
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
175,000 people suffer from Hodgkin's lymphoma.
Rich Pharmaceuticals' 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.
In 2005, a leading oncologist at the University of Medicine and Dentistry of New Jersey
(UMDNJ) conducted a Phase 1 investigator-sponsored trial in 35
patients using the study drug, TPA. This study determined the
maximum tolerated dose and described the side effects of the study
drug. The results of this Phase 1 trial led to interest by
the same investigator to initiate the next Phase of study.
See: Schaar, D., Goodell, L., Alisner,T., Cui X. X., Han,
Z. T., Chang, R.L., Marrtin, T., Grospe, S., Dudek, L., Riley, T.,
Manago, T., Lin, Y., Rubin, E. H., Conney, A. H., and
Stair, R. K.: A phase 1 clinical trial of
12-0-Tetradecanoylphorbol-13-acetate for patients with
relapsed/refractory malignancies. Cancer Chemptheray
and Pharmacol pp. 789-795, 2005.
Rich Pharmaceuticals submitted an investigational new drug
(IND) application in October
2014, to conduct a clinical trial for its lead
compound RP-323 in Acute Myelocytic
Leukemia (AML) and Myelodysplastic Syndrome (MDS) with the U.S.
Food and Drug Administration (FDA). Rich Pharmaceuticals
plans to initiate a multicenter, clinical study using RP-323 to treat AML and MDS patients. In
connection with the IND, Rich Pharmaceuticals was required to
manufacture sufficient quantities of RP-323 under GMP, which was recently completed at
state-of-the-art Wuxi Apptec Biopharmaceutical's facility based in
Shanghai, China.
On July 23, 2014, Rich
Pharmaceuticals retained Therinova Development, Inc., a
San Diego, CA based contract
research organization (CRO), to file its investigational new drug
(IND), and identify and supervise the next phase of clinical
development trial sites for the use of RP-323 in Acute Myelocytic Leukemia patients.
Therinova provides comprehensive product development
solutions for the biopharmaceutical industry, with offices in
San Diego, California. For
more information on Therinova, visit: www.therinova.com
On October 13, 2014, Rich
Pharmaceuticals entered into an agreement with Richard L. Chang
Holdings, LLC for ownership to its investigational cancer patent
assignment using Phorbol Esters in the treatment of Hodgkin's
Lymphoma. Under terms of the agreement, Rich Pharmaceuticals
will obtain complete ownership and all interest in the indication,
patents and intellectual property related to treatment of Hodgkin's
Lymphoma, utility patent application number 61998397, entitled
COMPOSITIONS AND METHODS OF USE OF PHORBOL ESTERS FOR
THE TREATMENT OF HODGKIN'S LYMPHOMA.
"We are elated about the progress we made in 2014. I
would like to personally thank our entire staff and consultants for
the tireless work they have and will be devoting to Rich
Pharmaceuticals to attempt to bring RP-323 to additional clinical studies. We
look forward to one day when there is a more effective non-evasive
treatment for AML and Hodgkin's lymphoma," said Ben Chang, Rich Pharmaceuticals'
CEO.
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.
For more infomraiton 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 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
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plans, expectations or intentions will prove to be accurate.
Investors should consult all of the information set forth herein
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SOURCE Rich Pharmaceuticals, Inc.