U.K. picks a controversial brain cancer vaccine as its first new 'innovative medicine'

Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine." But unlike the FDA, which has steered most of its breakthrough drug designations in the cancer field to the Big Pharma players' top oncology programs, the U.K. singled out a small U.S. biotech which is advancing a controversial new treatment for inoperable brain tumors for the country's new fast track.

First up will be Northwest Biotherapeutics ($NWBO), a Bethesda, MD-based biotech with a market cap slightly north of $300 million and a dendritic cell cancer vaccine, DCVax-L, designed to spur an immune system attack on tumors. Northwest Bio has been testing the treatment in studies for brain cancer, including glioblastoma, the most common type of brain cancer.

Like the FDA, the U.K.'s Medicines and Healthcare Products Regulatory Agency set up this innovative medicines program to demonstrate that it can get promising new therapies to patients swiftly, bypassing the usual bureaucratic stopping points in the U.K. and Europe, including a cost review by NICE. The next step will be to see if the U.K. will sign off on early access, a campaign that will include a review of the data, Northwest's case for its drug and its ability to properly manufacture a sufficient quantity of the drug.

Northwest's shares surged 8% on the news this morning, cheered on by company execs who also recently received permission from German officials to start treating brain cancer cases under a special hospital access program.

Northwest BIO CEO Linda Powers

DCVax-L, though, has attracted warring bands of admirers and critics.Northwest BIO CEO Linda Powers has fed the controversy with claims that the drug is a blockbuster in the making. And she told Reuters' Ransdell Pierson in a recent interview that the drug is worth more than the $65,000 to $70,000 a year that Merck ($MRK) gets for Temodar, based on the "informal" data. Powers has been backed up by EvaluatePharma, which designated this program as one of the most promising in the industry pipeline.

Powers' eagerness to project big future sales of an unproven cancer therapy, though, is exactly why the company often finds itself in the cross hairs of critics like Adam Feuerstein at TheStreet. Dendritic cancer vaccines, which promise to marshal an immune system attack on cancer, have an extremely poor record in the clinic, as do all the cancer vaccines. A few days ago, for example, Merck KGaA abandoned its long-troubled effort to develop tecemotide (Stimuvax). And small, unpartnered biotechs have a particularly grim record of failure in the oncology field.

Steve Bates, CEO of the U.K.'s BioIndustry Association, takes a different view. He says the news today is good for small biotechs and patients alike.

"I'm glad to see the first Promising Innovative Medicine certification being issued and encouraged to see the first user is a smaller company," he said in a note to FierceBiotech. "This shows it's open to all and hopefully this will be the first of many. This should enable U.K. patients to be amongst the first in the world to be offered personalized immune therapy for brain cancer. It's smart of nimble U.S. companies like Northwest Bio to pioneer new regulatory flexibility alongside the clinical development they are doing at King's College Hospital in the U.K."

Finding itself a pioneer in the U.K., Northwest Bio didn't miss the opportunity of making a shout-out about its progress.

"Brain cancers strike patients of all ages, and are rapidly lethal. New treatment options are urgently needed," said Dr. Keyoumars Ashkan, a senior neurosurgeon at King's College Hospital in London and the principal investigator for the clinical trial of DCVax-L in the U.K. "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."

- here's the release