BOTHELL, Wash., July 9 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. , is pleased to announce that it has received Authorization for Use from the Swiss Institute of Public Health (Bundesamt fur Gesundheit; "BAG") to make DCVax(R)-Brain commercially available for treatment of brain cancer patients in Switzerland. As such, DCVax(R)-Brain is the first commercially available therapeutic vaccine for such cancers. The Company intends to begin making the product available to patients in Q3 2007.
Dr. Alton Boynton, President and CEO of Northwest Biotherapeutics, said: "We are delighted to be the first company to reach the market with a personalized therapeutic vaccine for brain cancers, which carry a very bleak prognosis for patients today. We look forward to providing DCVax(R)-Brain at leading medical centers and hospitals in Switzerland. Switzerland is an attractive place to begin commercialization, due to its highly respected regulatory oversight, and its growing experience with cellular therapies. Switzerland is also increasingly noted for medical tourism, and is easily accessible for many medical tourists. We look forward to being able to bring DCVax(R)-Brain to patients in additional countries, and to applying our DCVax(R) technology to many other cancers, including the five for which we already have FDA clearance to begin clinical trials."
"Finally, we are especially pleased to achieve such a major milestone substantially ahead of schedule and so soon after our flotation on the AIM market of the London Stock Exchange."
Brain cancers can strike all ages, and are the leading cause of cancer deaths in children under the age of 20. Brain cancers are among the most rapidly lethal cancers: with the limited treatments available today, even newly diagnosed patients have a median survival of only 14.6 months. In clinical trials, both newly diagnosed and recurrent brain cancer patients treated with DCVax(R)-Brain had more than double the survival time of patients who did not receive DCVax(R)-Brain (to over 33 months and continuing -- median not yet reached -- for newly diagnosed patients). In addition, unlike chemotherapy, DCVax(R)-Brain does not cause any debilitating side effects.
Under the Swiss Authorization for Use, the Company is permitted to manufacture DCVax(R)-Brain in the US and make it available for the treatment of patients with brain cancer at select centers in Switzerland. The Authorization was granted in response to the Company's application in mid-February, 2007. It was based upon the Company's clinical data to date, and upon an extensive inspection by Swissmedic (the Swiss Agency for Therapeutic Products) on behalf of the BAG.
NWBT's DCVax(R) is a platform technology which is anticipated to be applicable to most cancers. DCVax(R) works by mobilizing the full spectrum of immune response, both innate and adaptive, rather than just single immune agents such as antibodies alone or T cells alone. As such, DCVax(R) mobilizes the patient's immune system to function in its normal, natural way. This leads to both improved efficacy and lack of problematic toxicities. Unlike conventional cancer drugs, DCVax(R) does not cause any debilitating side effects.
DCVax(R) products are personalized treatments, made by combining a patient's own master immune cells (dendritic cells) with cancer biomarkers derived from or displayed by the patient's own tumor. Precursors of the master immune cells are continuously circulating in a patient's blood and are obtained through a blood draw. The master immune cells are then matured and activated through a series of proprietary steps, then "educated" by exposure to the patient's tumor biomarkers, and injected back into the patient through a simple intradermal injection in the arm or thigh, consisting of just a few drops.
Unlike many personalized therapies under development, DCVax(R) products will be cost-effective. The key to their cost-effectiveness is a proprietary batch manufacturing process pioneered by NWBT, through over 10 years of development, under which a single manufacturing run is used to produce at least 3 years of personalized treatments for a particular patient. The treatments are stored frozen in single-dose vials, ready for use on an off-the-shelf basis for that patient. Such storage is highly reliable and low cost. By doing only one manufacturing run, and thereafter having the product available off-the-shelf, NWBT is able to keep the costs of its personalized vaccines at a level that can enable product pricing in a range comparable to other cancer drugs.
In parallel with making DCVax(R)-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial.
DCVax(R)-Brain has been granted orphan drug status in both the US and the EU. Such status will afford DCVax(R)-Brain 7 years of market exclusivity in the US and 10 years in the EU, if DCVax(R)-Brain is the first product of its type to reach product approval.
Clinical trial data to date in brain cancer patients have shown that DCVax(R)-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients. DCVax(R)-Brain also extends these patients' survival from 14.6 months to more than 33 months (and continuing -- median not yet reached).
The DCVax(R) Technology platform is anticipated to be applicable to most cancers. NWBT is already at the Phase III, pivotal trial stage in prostate cancer, and has also received FDA clearance for clinical trials in five other cancers (including lung cancer, the leading cause of cancer deaths worldwide). Clinical trial data to date in hormone independent prostate cancer patients have shown striking results similar to the results in brain cancer
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. is a US-based biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis.
The Company has two broad platform technologies:
(1.) dendritic cell-based therapeutic vaccines and (2.) antibody drugs. The Company's lead product candidates are:
1. DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has reached the market commercially in Switzerland and, in parallel, has been under way since December, 2006, in a Phase II pivotal clinical in the US which is expected to finish around the end of 2008; and 2. DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which has been cleared by the FDA to enter a Phase III pivotal clinical trial in the US.
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such risks related to the company's ability to successfully commercialize DCVax(R)-Brain in Switzerland, the company's ability to enroll patients in its Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process, the timely performance of third parties, and whether DCVax(R)-Brain will demonstrate safety and efficacy and the timely performance of third parties. Additional information on these and other factors, which could affect the company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the company's SEC filings that may cause actual results to differ materially those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.