Northwest Biotherapeutics (NW Bio; MD, USA) have today announced that one of their DCVax® personalized immune therapies for solid tumor cancers termed DCVax-L is the first product to receive formal designation as a ‘Promising Innovative Medicine’ (PIM) under the new ‘Early Access to Medicines Scheme’ (EAMS).
The EAMS was launched earlier this year by the Medicines and Healthcare Products Regulatory Agency in order to assist in the acceleration of patient access to new medicines for serious diseases. The PIM designation for DCVax-L covers it for all malignant gliomas, both recurrent and newly diagnosed.
“Brain cancers strike patients of all ages, and are rapidly lethal. New treatment options are urgently needed. DCVax-L offers an exciting new approach to treating these brain cancers, through personalized immune therapy. It is encouraging to see this innovative new product be the first to receive certification as a Promising Innovative Medicine under the new EAMS,” commented Keyoumars Ashkan of King’s College London (UK), Chief Investigator of the DCVax-L clinical trial in the UK.
This PIM designation is the first step in a two-step process for early access approval under the EAMS. To gain the PIM designation, the agent was evaluated by the Medicines and Healthcare Products Regulatory Agency to determine whether it met the three PIM criteria. These criteria include: (i) the product is for a serious disease or condition with high unmet medical need; (ii) the product is likely to offer a major advantage over treatments available today; and (iii) the potential adverse effects of the product are outweighed by the potential benefits.
In response to this first PIM designation, the UK Department Of Health has stated, “An innovative cell therapy for cancer has become the first to be certified as ‘promising’ as part of a new Government scheme aimed at getting new medicines to patients quicker. The medicine…is the first drug to be awarded the UK’s new PIM designation, the initial step in the EAMS which aims to increase patient access to unlicensed treatments.”
The second step in the EAMS is the determination of the Scientific Opinion concerning the benefits and risks of the product based upon the available clinical data. At this stage the product will be judged based on the same criteria as the PIM designation with the addition of a fourth: the company’s ability to manufacture the product to rigorous ‘GMP’ clinical grade standards.
The Medicines and Healthcare Products Regulatory Agency aim to deliver a Scientific Opinion within 90 days of an application for step two of the EAMS process. If this is returned with a positive opinion, DCVax-L may then be prescribed by physicians and provided to patients while it is still in clinical development.
“In prior Phase I/II clinical trials of DCVax-L for brain cancer, significant delays in disease progression and significant extensions of patients’ survival have been seen, with virtually no serious adverse effects. We believe that DCVax-L embodies the combination of innovation and beneficial balance of clinical benefits and risks that the EAMS is designed to accelerate. We are excited that DCVax-L has received the first PIM certification,” Linda Powers, CEO of NW Bio commented.
“We are most grateful to the MHRA and Minister Freeman for spearheading this new 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,” Powers continued.