CAUMZ targeting survival indications in advanced incurable cancer.
Eligible for Fast Track designation and Accelerated Approval regulatory program.
505(b)(2) NDA pathway provides significant cost savings.
OTTAWA, Feb. 25, 2020 (GLOBE NEWSWIRE) — 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 provide additional information on the drug development program for CAUMZ™ following the previously announced Type B meeting with the US Food and Drug Administration (FDA).
The first indication for CAUMZ™ will be the treatment of cancer cachexia patients. To ensure minimal time to market, the first target patient population will be cancer cachexia patients that have an 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. Providing these types of benefits to a cancer patient with cachexia would provide an important contribution to the care of these patients and their wellbeing.
Cancer cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. Its pathophysiology is characterised by a negative protein and energy balance driven by a variable combination of reduced food intake and abnormal metabolism. The agreed diagnostic criterion for cachexia was weight loss greater than 5%, or weight loss greater than 2% in individuals already showing depletion according to current bodyweight and height (body-mass index [BMI] <20 kg/m2) or skeletal muscle mass (sarcopenia).3
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A key aspect to Tetra’s technology is the selective delivery of cannabinoids to the central nervous system using the CAUMZ™-kit technology. Avoiding the first pass metabolism that occurs with the oral or sublingual route of administration is important to minimize the formation of metabolites associated with some of the side effects. The highly purified cannabinoid molecules are also an important element in the future success of CAUMZ™. CAUMZ™-kit results in the inhalation of cannabinoid molecules and not any compounds such as excipients, preservatives or oils.
The manufacturing technology licensed from Vitiprints LLC (disclosed on February 13, 2020 new release) allows Tetra to manufacture cannabinoid drugs for inhalation and does not involve the use of other ingredients. This is critical for ensuring the safety and tolerability of CAUMZ™ in patients.
Drugs developed with cancer indications that involve claims for survival typically go down the Accelerated Approval (“AA“) regulatory path. Regulators agree that it is too long to wait for the demonstration of survival in patients to grant marketing approval. Instead regulators allow for the use of validated surrogate endpoints to expedite bringing the drug to patients. Once approved under the AA, the company continues to assess survival directly to obtain the non-conditional approval. CAUMZ™ is designed to prolong survival and improve quality of life and the patient’s day-to-day functioning. These are all important benefits for a patient with advanced cancer.
Tetra expects to obtain the Fast Track designation from the FDA for expedited review of its CAUMZ™ drug product which treats a serious condition and fills an unmet medical need. As stated in a previous news release, the FDA agreed that the target patient population has a serious condition with significant morbidity. If the disease of the target patient population is not treated with CAUMZ™, the patient’s health and wellbeing will continue to deteriorate to a more serious condition. In fact, if the cachectic state is not reversed the patient does not have a good probability of survival since the disease is incurable.
As CAUMZ™ shares similarities to QIXLEEF™, the FDA confirmed in the Type B meeting that CAUMZ™ would be eligible for waivers of some of the standard nonclinical toxicology studies. “Confirmation of the waivers represents a short-term savings of over $5 million dollars for the first marketing application of CAUMZ™ as well as further potential savings” stated Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra.
The decision by FDA that the CAUMZ™-kit would be approvable under the 505(b)(2) New Drug Application (NDA) approval pathway is very favorable to Tetra as this will provide additional significant cost savings to the Company. The Company’s NDA application would rely upon literature to support the nonclinical requirements of the NDA, Tetra expects additional short-term savings of over $2 million dollars. The additional financial benefit to Tetra is that the FDA, under the 505(b)(2) pathway recognizes the safety of each of the two drugs, THC and CBD, used alone. Tetra therefore only needs to address the safety of the combination and aspects unique to the inhalation route of administration. The latter being addresses by the clinical trials of CAUMZ™. This reduced clinical burden will also translate into a third short-term savings by over $2 million dollars. Chamberland added, “The 505(b)(2) pathway does not prevent Tetra from a Fast Track and Accelerated Approval. These cost savings will ultimately translate back to the patient.”
The FDA reviewed Tetra’s proposed approach to ensuring the quality of the CAUMZ™-kit, device component and drug product specifications. In the case of CAUMZ™, there are no scientific challenges for demonstrating lot-to-lot because of the high purity and quality of the drug product. Tetra must still demonstrate to the FDA that the CAUMZ™ drug batches used in clinical trials will be comparable to those of the commercial lots as well as those that were used at every stage of the drug development program. However, this task will be the same as for any other prescription drug because CAUMZ™ only contains cannabinoids in the drug product.
According to BCC Research (Jan 2019 report: Global Cancer Therapeutics Market: Emphasis on Recurrent and Metastatic Divisions), the global cancer therapeutics market is growing from $128.1 billion in 2018 to $182.0 billion by 2023 at a compound annual growth rate (CAGR) of 7.3%. “With this feedback from the FDA we are confirming CAUMZ™ now represents a strategic priority as Cancer Cachexia is currently an unsatisfied market and we believe that CAUMZ™ will also become an important therapeutic in the overall battle against cancer. Tetra will also investigate the use of CAUMZ™ as an adjunct to anticancer therapies with the hope of demonstrating improved disease-free survival, improved quality of life and improving the patient’s day-to-day functioning. CAUMZ™’s route of administration (inhalation), odorless characteristics and selective delivery to the central nervous system will allow the CAUMZ™-kit to carve a place in this huge market” commented Dr. Chamberland.
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