FDA conditions met for Fast Track designation
– patient population has a serious condition with significant
morbidity.
Qualified for Accelerated Approval regulatory
program – Tetra confirms Patient-Reported Outcome (PRO) instrument
is a validated surrogate endpoint.
CAUMZ to be reviewed under the 505(b)(2)
pathway – leverage previously approved cannabinoid drugs.
FDA guidance allows expansion into a larger
cancer therapeutics market for CAUMZ and avoids direct competition
with QIXLEEF.
OTTAWA, Feb. 3, 2020 /CNW Telbec/ - Tetra Bio-Pharma
Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), a
leader in cannabinoid-derived drug discovery and development, is
pleased to announce that it has now received the much anticipated
response from the United States Food and Drug Administration (the
"FDA") following its previously announced Type B meeting with the
FDA for its drug-device combination product CAUMZ which is slated
for the management of patients with advanced incurable malignant
cancer, refractory to treatment, with symptoms uncontrolled by
standard of care.
This news release addresses the material aspects of the
decisions taken by the FDA and implications of the guidance
provided by the FDA. Tetra will provide information on the
other decisions provided by the FDA as well as further elaborate on
the implications of the material decisions once assessed by
management.
The purpose of the Type B meeting was to obtain (1) confirmation
of the eligibility of CAUMZ for Expedited Review programs Fast
Track and Accelerated Approval, (2) clarification on the
requirements for the medical device portion of the New Drug
Application ("NDA"), (3) validation of the nonclinical
safety program by indication (original NDA and supplement NDA), and
(4) guidance on the study protocols that would be used to bring
CAUMZ to the market.
Expedited Review programs Fast Track and Accelerated
Approval
Fast Track is a designation granted by the FDA for expedited
review of drug products which treat a serious or life-threatening
condition and fill an unmet medical need. In its response,
the FDA agreed that the target patient population has a serious
condition with significant morbidity. Tetra's clinical data
to date has allowed management to make the assessment that CAUMZ
will affect the survival of patients with an advanced cancer and
affect their day-to-day functioning. If the disease of the target
patient population is not treated with CAUMZ, their health and
wellbeing will continue to deteriorate to a more serious
condition. With regards to unmet medical need, this patient
population does not respond to any available therapy and CAUMZ will
provide an improved effect on a serious outcome of the
condition. These are the basic requirements for eligibility
to Fast Track and other Expedited Review Programs. The FDA
agreed that the Company, meeting the conditions in the regulations,
could now proceed to submit a Fast Track designation request to the
review division. The FDA reviews the request and, in general,
decides within sixty days.
The Fast Track designation reduces review time from an average
of 10 months to 6 months which is critical to provide patients
rapid access to new drugs. It also allows for frequent
communications with the FDA which ultimately reduces the risk of
delays by ensuring that all of the drug development issues are
adequately addressed by the development program.
The FDA reviewed Tetra's request that CAUMZ should qualify for
Accelerated Approval ("AA") for its target patient
population. Accelerated Approval is a regulatory program for
drugs, like CAUMZ, that are developed for the treatment of serious
conditions in which the use of a surrogate endpoint is justified
because the measured clinical benefit takes a long time to
measure. Pain is directly measured using several validated
pain scales and a drug being developed with an intended use of pain
relief would not be eligible for AA. The FDA then provided
guidance how Tetra could use a Patient-Reported Outcome
("PRO") instrument that could demonstrate the claimed
benefit in the target population.
Based on the FDA guidance, CAUMZ is a treatment intended for
cancer cachexia patients with an advanced, incurable and malignant
cancer that is refractory to treatment. CAUMZ is designed to
prolong survival and improve quality of life and the patient's
day-to-day functioning. Tetra confirms that it will be using
a validated surrogate endpoint that is a PRO instrument and that
the Company will be moving ahead with the clinical development of
CAUMZ based on the AA regulatory program.
The FDA stated that they had not previously approved a drug
product with this specific intended use and provided detailed
guidance on the development program. Dr. Guy Chamberland, CEO and Chief Regulatory
Officer of Tetra stated "With this feedback from the FDA we are
confident that we can develop QIXLEEF as botanical drug-device
combination product for cancer and noncancer pain indications and
that both products will be well differentiated from a medical point
of view. This refinement of the intended use for CAUMZ does
not affect the clinical trial patient population nor the clinical
sites participating in the Serenity© clinical
trial.
Combination Product Regulations & 505(b)(2) NDA
Pathway
CAUMZ is the next generation of QIXLEEF that was
created based on the intellectual property developed by the
Company. The clinical development program of CAUMZ was
designed to address a potential decision by the FDA that the
medicinal component of the CAUMZ-kit was a drug-drug combination
product. The FDA response stated that the CAUMZ drug
component is a drug-drug combination product and that Tetra would
have to address the interaction of these two drugs (specifically
CBD and THC) in its clinical development program. The
information package submitted for the Type B meeting contained how
Tetra intended to address this interaction and the FDA provided
detailed guidance on the approach.
Subsequent to the above decision, the FDA stated that Tetra had
proposed a 505(b)(2) NDA in its Information Package, meaning that
the Corporation's NDA application could rely upon literature to
support the nonclinical requirements of the NDA. The decision
by FDA of the drug-drug combination product and the NDA 505(b)(2)
approval pathway is favorable to Tetra.
Essentially, the 505(b)(2) pathway allows a corporation to avoid
unnecessary duplication of studies already performed on a
previously approved drug and it legally allows the FDA to rely on
data not developed by Tetra. The 505(b)(2) type of NDA
contains the complete safety and efficacy reports but allows that
some of the data required for approval, such as safety and efficacy
information on the THC and CBD drugs, to come from studies not
conducted by Tetra. Dr. Guy
Chamberland, commented "our shareholders may benefit from
this decision as the 505(b)(2) results in a lower overall cost of
development and faster route to marketing approval." He
added, "This pathway does not prevent Tetra from a Fast Track or
Accelerated Approval. "
Chamberland added "Based on the FDA decisions and guidance,
Tetra confirms that CAUMZ will be able to benefit from three
regulatory decisions-programs: 505(b)(2) which will lower overall
costs, Fast Track designation, and Accelerated Approval which may
reduce the time to market." With this feedback from the FDA,
Tetra has two novel drug products that will be well differentiated
from a medical point of view. QIXLEEF will continue to be
developed as a drug-device combination product, benefit from the
botanical aspects of the drug and be evaluated by the analgesic
drug division. QIXLEEF is being developed for cancer and
noncancer pain indications. CAUMZ will be developed as
drug-device combination product with the drug component being a
drug-drug combination product and it will be evaluated by the
oncology drug division of the FDA. This prescription drug
product is inline with Tetra's mission to bring safe and
efficacious alternatives to patients suffering from cancer or any
chronic pain condition."
About Tetra Bio-Pharma
Tetra Bio-Pharma
(TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in
cannabinoid-based drug discovery and development with a Health
Canada approved, and FDA reviewed and approved, clinical program
aimed at bringing novel prescription drugs and treatments to
patients and their healthcare providers. The Company has several
subsidiaries engaged in the development of an advanced and growing
pipeline of Bio Pharmaceuticals, Natural Health and Veterinary
Products containing cannabis and other medicinal plant-based
elements. With patients at the core of what we do, Tetra Bio-Pharma
is focused on providing rigorous scientific validation and safety
data required for inclusion into the existing bio pharma industry
by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
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Forward-looking statements
Some statements in this
release may contain forward-looking information. All statements,
other than of historical fact, that address activities, events or
developments that the Company believes, expects or anticipates will
or may occur in the future (including, without limitation,
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Company to differ materially from those discussed in the
forward-looking statements. Factors that could cause actual results
or events to differ materially from current expectations include,
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Company to obtain sufficient financing to execute the Company's
business plan; competition; regulation and anticipated and
unanticipated costs and delays, the success of the Company's
research and development strategies, including the success of this
product or any other product, the applicability of the
discoveries made therein, the successful and timely completion and
uncertainties related to the regulatory process, the timing of
clinical trials, the timing and outcomes of regulatory or
intellectual property decisions and other risks disclosed in the
Company's public disclosure record on file with the relevant
securities regulatory authorities. Although the Company has
attempted to identify important factors that could cause actual
results or events to differ materially from those described in
forward-looking statements, there may be other factors that cause
results or events not to be as anticipated, estimated or intended.
Readers should not place undue reliance on forward-looking
statements. The forward-looking statements included in this news
release are made as of the date of this news release and the
Company does not undertake an obligation to publicly update such
forward-looking statements to reflect new information, subsequent
events or otherwise unless required by applicable securities
legislation.
SOURCE Tetra Bio-Pharma Inc.