MedLab Clinical has started the Observational Study of its flagship cancer pain drug NanaBis.
Medlab Clinical Ltd (ASX: MDC) has officially launched the NanaBis Observational Study that received Ethics approval in June last year.
The study is designed to test the impacts of NanaBis in conjunction with other prescribed medicines on patients and is assigned a Clinical Trial Number by the Therapeutic Goods Administration (TGA.)
The NanaBis will be prescribed through the Australian Government's Special Access Scheme and the study will be performed off the back of MDC's recently completed Phase 2 Cancer Trial at RNSH, with the end-goal of moving toward drug registration and a Phase 3 trial in both Australia and the United States.
Medlab is aiming to recruit 2,000 Australians to provide the company intervention data over a one year period, and the company expects to provide for roughly 700 patients currently diagnosed with cancer pain. The final group will center around those suffering from non-cancer related pains.
The benefit for patients who enroll in the study is that they will gain access to NanaBis at a lowered cost, and the benefit for doctors is that they will be reimbursed for their involvement in the study based on the hours they spend with each patient. Medlab recently conducted a soft launch, in which 12% of participants were enrolled, including 125 doctors and 256 patients.
Should the company need to increase demand, Medlab's recently announced commercial agreement with TASALK will allow Medlab to increase manufacturing.
Key points demonstrated are:
- 16% cancer pain
- 84% non-cancer pain
- 28% soft tissue pain
- 18% visceral pain
- 38% muscular pain
- 54% neuropathic pain
Medlab CEO, Dr Sean Hall said "Medlab will be working closely with healthcare professionals to provide educational tools to better understand NanaBis™ as a treatment option for patients living with chronic pain. Participating patients will have access to medical cannabis at a significantly reduced price."
NanaBis™ is a standardised, purified 1:1 concentration of CBD and THC in MDC's proprietary nanoparticle delivery platform, NanoCelle™. NanaBis™ is a drug candidate being investigated for use in cancer pain management with data to date very encouraging.
To learn more about Medlab Clinical, visit the company HQ here.
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