Imitrex injection for sale clinical trials. We have also developed a second treatment, cetuximab, which has been clinically approved for T cell cytotoxic therapy B-cell malignancies and systemic lupus erythematosus.
In 2013, we initiated our first clinical trial of cetuximab and adalimumab, our cetuximab-based monoclonal antibody for the treatment of multiple sclerosis.
We have not received any nonclinical license applications or orders for the development of our cetuximab drug candidates related to the use of our drugs. Also, we have never received regulatory approval from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other regulatory authorities outside the United States for use of our cetuximab drugs in the United States for treatment of primary CNS cancers.
Cannabis for Medical Treatment
In 2012, we received approval for a Phase 2, randomized, double-blind, placebo-controlled trial, which evaluated the safety and tolerability of our CBD-based drug product CBD (2.5 mg/kg/day, peroral and mucosal adjuvant) in patients having an advanced stage of multiple myeloma. An adverse event review of the trial Imitrex 25mg $580.94 - $4.84 Per pill was completed in August 2014. We have received a separate regulatory approval from the Health Canada, under Access to Cannabis for Medical Purposes Regulations, to acquire, manufacture, produce and supply our CBD-based drug product.
We have an exclusive license from Health Canada under the Access to Cannabis for Medical Purposes Regulations, to produce and sell medical cannabis under the Access to for Medical Purposes Regulations eligible persons who are authorized to produce or possess industrial hemp under the Marihuana for Medical Purposes Regulations and includes designated producer producer's production limit of no more than 30,000 kg in the initial production year and no more than 30,000 kg thereafter. The company expects to begin producing medical cannabis for sale with production of the first product in fourth quarter of 2016 and to obtain a license produce medical cannabis from Health Canada to produce additional amounts of product for sale throughout 2017.
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Our CBD product is now in Phase 2 clinical trials patients who have early stage multiple myeloma. We anticipate that our first product will commence its commercial release in the second quarter of 2017 and enter into commercial production in the fourth quarter of 2016. In early 2016, the FDA issued a complete and mandatory warning to the manufacturers of CBD, terpene content and other potential safety issues proposed a number of regulatory amendments to the Marihuana for Medical Purposes Regulations, which has affected the status of our product candidates being investigated by Health Canada and we expect to be the only company in Canada that is licensed to manufacture and sell our CBD product. In early January 2016, the European Medicines Agency completed a first stage study that examined the safety, tolerability and pharmacokinetics of CBD, as well its antitumor activity, in patients with advanced melanoma. We expect our clinical trial of second product, adalimumab, in patients with relapsed or refractory multiple myeloma based on our first product CBD and expected approval from Health Canada based on the results of that trial.
We believe our research and the development of our pharmaceutical grade CBD-based product, CBD, may lead to the development of other novel cannabinoid-based drug applications in the future. At this time, we do not have any clinical research data to support other clinical applications of our drug candidates for the treatment of pediatric, pediatric anorexia-associated, autoimmune diseases, or any other indication.
Non-clinical Data
Our proprietary platform of drug products combines the biological and pharmacological activity of our proprietary CBD-based drug products with our proprietary gene sequencing expertise. platform of bioinformatics tools and genetic molecular analysis algorithms has been engineered to identify therapeutic potentials by facilitating analysis of our own proprietary clinical candidate data. We also leverage our platform by identifying new drug targets that may be targeted by others in the space of alternative therapies for various diseases by extracting drug data from published literature and other data sources. Our proprietary platform has developed techniques to identify new drug targets via our patent-protected platform of bioinformatics analysis techniques.
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