Cannabis Science Continues Forward with FDA IND Process as Patients Report Successful Cancer Treatments
03 April 2012 - 2:31AM
Business Wire
Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech
company developing cannabis pharmaceutical and over the counter
nutraceutical products, is pleased to report it is moving forward
with its FDA IND process. We have kept the public up to date with
self-medicated skin cancer patients who are benefiting from topical
cannabis-based extracts. These patients have experienced dramatic
reduction in tumor burden and for some apparent eradication of
their skin cancers.
The Company has received from our consultants its initial review
for Pre-IND preparation work and for the submitting Pre-IND request
letter. With several questions answered and confirmed for the
Company, the Company will sign off and its’ consultants will
prepare the Pre-IND meeting submission package.
The Company and its FDA specialists understand the regulatory
strategy and guidance, the timelines for preparation, and the
conduct required at the FDA pre-IND meeting. These timelines are
determined by FDA policy with the aim of facilitating the
application process. The budget review was positive and
realistic consisting of estimates of consultant hours, costs,
activities, recurring activities, travel and other direct
expenses.
Federal law requires that a marketing application for a new drug
be approved before the drug can be transported or distributed over
state lines. A sponsor will want to ship the investigational drug
to clinical investigators, and therefore must seek an exemption
from any existing legal restrictions. When a drug is in preclinical
development, the sponsor’s primary goal is to make sure the product
is safe for initial testing on humans and that the pharmacological
activity justifies commercial development. When a product is
determined to be a viable candidate for further development, the
sponsor collects data and information necessary to establish that
the product will not harm humans or exposes them to unreasonable
risks when used in limited clinical studies.
Cannabis Science and cancer patients look forward to benefiting
from the company’s formulations when they become available on the
mainstream market. Cannabis Science is confident as to the efficacy
of its products since they are currently used by patients on a
limited intra-state basis.
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of pharmaceutical
grade medical marijuana research and development. The second
formulations will address the needs of patients choosing to use
concentrated cannabis extracts to treat their ailments. Eventually,
all Americans will have access to a safe and effective FDA approved
medicine regardless of which state they live in. To maintain that
marijuana is a dangerous, addictive drug with no medical value is
scientifically absurd. Cannabis medicines, with no effective lethal
dose, are far safer than aspirin, acetaminophen, and most other OTC
drugs that kill thousands of Americans every year.
The Company works with world authorities on phytocannabinoid
science targeting critical illnesses, and adheres to scientific
methodologies to develop, produce and commercialize
phytocannabinoid-based pharmaceutical products. In sum, we are
dedicated to the creation of cannabis-based medicines, both with
and without psychoactive properties, to treat disease and the
symptoms of disease, as well as for general health maintenance.
Forward Looking Statements
This Press Release includes forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Act of 1934. A statement containing
works such as "anticipate," "seek," intend," "believe," "plan,"
"estimate," "expect," "project," "plan," or similar phrases may be
deemed "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Some or all of
the events or results anticipated by these forward-looking
statements may not occur. Factors that could cause or contribute to
such differences include the future U.S. and global economies, the
impact of competition, and the Company's reliance on existing
regulations regarding the use and development of cannabis-based
drugs. Cannabis Science, Inc. does not undertake any duty nor does
it intend to update the results of these forward-looking
statements.