NW Bio's Cancer Vaccine First To Receive PIM Designation In U.K.'s Early Access Scheme
Northwest Biotherapeutics (NW) announced that its new cancer immune therapy, DCVax-L, is the first drug to receive “Promising Innovative Medicine” (PIM) designation by the U.K.’s new “Early Access to Medicines Scheme” (EAMS). Like the U.S.’s compassionate use program, the EAMS aims to get urgently needed drug therapies to patients more quickly.
Launched in April, EAMS is a three-step process. First, applications are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA) by pharma companies and research organizations. If the MHRA decides that the drug meets the necessary criteria, the drug is issued a PIM designation and enters step two of the process where researchers and doctors evaluate the drug’s risk/benefit and manufacturing consistency. If the drug passes the first two stages successfully, the drug must be approved by the NHS commissioning board.
In order to receive the initial PIM designation, a drug must demonstrate through clinical data its efficacy in treating the unmet needs of patients with a lethal or highly debilitating disease. The drug also needs to prove that it offers serious advantages over existing treatments, and that its benefits outweigh any potential negative side-effects.
Once the drug receives this initial designation, it is made available to doctors along with a detailed report of potential risk.
Ian Hudson, chief executive of the MHRA states, “The launch of this scheme will mean that the MHRA issues an opinion that supports prescribers in deciding to use an unlicensed medicine for conditions where there are no or inadequate treatment options available to them.”
NW’s DCVax-L is intended for the treatment of malignant gliomas, both newly diagnosed and recurring. The treatment makes use of the patient’s own white blood cells to mix with proteins from the brain tumor to effectively “teach” the patient’s immune system how to fight and kill the cancerous cells.
Keyoumars Ashkan, British neuro-surgeon and lead investigator in DCVax-L’s U.K. clinical trials, explains the urgency of effective brain cancer treatments. “Brain cancers strike patients of all ages and are rapidly lethal… DCVax-L offers an exciting new approach to treating these brain cancers through personalized immune therapy.”
According to Linda Powers, CEO of NW Bio, DCVax-L is exactly the sort of treatment that EAMS was designed to assist.
She explains, “In prior Phase 1/2 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.”