An experimental immunotherapy developed by Northwest Biotherapeutics Inc, has been designated as “promising innovative medicine” (PIM) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the initial step in the Early Access to Medicines Scheme (EAMS), which aims to increase patient access to medicines where there is an unmet medical need.
DCVax-L is an immunotherapy vaccine that uses a patient’s own tumor lysate and white blood cells to isolate dendritic cell precursors and “educate” them to induce the immune system into recognizing brain cancer cells.
Two Phase I/II clinical trials have already been conducted to assess the efficacy of DCVax-L, with 39 patients suffering from glioblastoma multiforme (GBM) who received DCVax in addition to standard of care treatment, not suffering from tumor recurrence for a median of approximately 2 years and surviving for a median of approximately 3 years.
Currently, the company is conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM patients.
UK’s government wants to strengthen the country’s research and development industry, making it one of the best countries in the world for capitalizing on breakthroughs in medical care.
The Early Access to Medicines Scheme will provide severely ill patients with life-threatening and seriously debilitating conditions the opportunity to use new and innovative medicines before these reach the market.
The PIM was created to give an early boost to a drug’s potential, becoming beneficial for both companies and patients.
“Making Britain the best place in the world for science, research and development is a central part of our long term economic plan. We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies, which is central to our life science strategy. This Promising Innovative Medicine designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families. This scheme is helping to secure a better future for people and proves that our country is leading the world in Life Sciences. I hope more companies — big and small – and medical charities, will nominate products to be part of this scheme,” George Freeman, UK Life Sciences Minister stated in a UK Department of Health and Life Sciences press release.
Linda Powers, CEO of Northwest Biotherapeutics Inc, added in the press release “We are most grateful to the MHRA and Minister Freeman for spearheading this new Early Access to Medicines Scheme (EAMS). It strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options. We are very excited to have DCVax-L receive the first designation under the EAMS, and believe that DCVax-L embodies the combination of innovation and beneficial balance of clinical benefits and risks that the EAMS is designed to accelerate.”
Northwest Biotherapeutics will continue to develop the vaccine, and if the Phase III clinical trial proves successful, it will become eligible to apply for step II of the UK Early Access to Medicines Scheme, translating into an improved benefit for the patients and the continued progression of the drug’s development.