New results show that Medlab's flagship cannabis drug, NanaBis, achieves meaningful pain reduction in patients with breast or prostate cancers.
NanaBis is the company's cannabis-based pain management product, comprised of a proprietary 1:1 blend of highly purified cannabidiol (CBD) and tetrahydrocannabinol (THC) molecules. NanaBis was developed as a pain management alternative to traditional opioids—particularly for patients suffering from advanced types of cancer and chronic pain.
The clinical trial was designed to investigate the pain management of patients with metastatic cancers, and it found that NanaBis™ was safe, tolerable, efficacious and that dosage tolerance was achieved at 60% of the maximum dosage.
NanaBis™ also demonstrated to be fast-acting, with maximum concentration in serum to be 54 minutes.
The company met many of its targetted Secondary Endpoints, namely that the total patient cohort had meaningful pain reduction, with those suffering from breast or prostate cancers with bone metastasis reporting an average of 40% improvement in pain scores from baseline.
Breast or prostate cancers with bone metastasis showed a significant decrease in their use of dispensed opioid analgesics, also known as "breakthrough drugs" which are typically used when pain symptoms arise.
The company intends to use these results in order to launch MDC into its Phase 3 designs, specifically in the patient group with metastatic bone pain where breast or prostate are the primary cancers.
MDC's announcement mentions that there are an estimated 600,000 patients suffering from metastatic breast or prostate cancers in the USA, Canada, Europe and Australia who have "high unmet needs" as of 2017. Since the completion of the Trial, the majority of patients involved have elected and approved to continue using NanaBis™ free of charge.
Dr Sean Hall, CEO of MDC states, "with a strong trial design, that involved a professional and strong clinical trial team and collaborators, today we have primary evidence that NanaBis™ is safe, tolerable and provided a significant benefit in managing pain associated with metastatic cancers. There were a number of notable secondary gains, one of the biggest worth mentioning was a drastic reduction of breakthrough medication used by those patients with breast or prostate cancers with bone METs."
We can confidently argue, NanaBis™ has a strong indication for use in pain management and is a compelling therapy for this patient group. Dr Sean Hall, CEO of Medlab Clinical
Professor Luis Vitetta, Director of Medical Research at MDC states, "the completion of Medlab's SAD/MAD clinical study with NanaBis™ in advanced cancer pain management has proven safe. Furthermore, the results relevant to pain management provides information that allows progression to the next phase of NanaBis™' development. The design of a robust Phase 3 clinical study and it's successful completion will advance the path toward registration for NanaBis™, as an alternative analgesic medication."
Moving forward, Medlab will undertake a secondary evaluation of the data whilst preparing for the upcoming Phase 3 clinical trials. To learn more about Medlab Clinical, visit the company HQ here. You can also find the company's recent presentation on NanaBis here.
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