Northwest Biotherapeutics Reports Encouraging Data on First Patients Who Have Completed Its Phase I/II Clinical Trial of DCVax-L in Metastatic Ovarian Cancer
BETHESDA, Md., December 23, 2008 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT") today announced encouraging data on clinical responses in the first two case reports of patients who have completed the Company's Phase I/II clinical trial with DCVax(R)-L personalized cancer vaccine for recurrent, metastatic ovarian cancer.
This trial is ongoing, and is treating "no option" patients who have already been treated with most or all major drugs currently available for recurrent, metastatic ovarian cancer (including carboplatin, paclitaxel, docetaxel, abraxane, gemcitabine and topotecan), and whose cancer has still continued to progress. In other recent clinical trials testing various drugs and drug combinations for recurrent ovarian cancer, the treated patients have generally attained less than 3 or 4 months without progression of their cancer, and have experienced serious side effects (including gastro-intestinal perforation, a life-threatening condition).
In NWBT's trial, the two patients who have received treatment attained 8 months and 6 months without progression, respectively. Each of these NWBT patients had metastases in 4 or 5 locations at the beginning of the trial and, in both of the patients, all of their metastatic lesions responded following the treatment regimen -- either by shrinking somewhat (20-25%), or by remaining the same size and not growing, or by disappearing. The patients did not experience any toxicity or debilitating side effects.
Metastatic ovarian cancer poses a particularly serious and urgent unmet medical need. In most patients, the disease is not discovered until is it already late stage, because ovarian cancer typically causes little or no symptoms until it is late stage. When this cancer has metastasized, as in the case of the no-option patients in NWBT's trial, the cancer usually progresses rapidly and aggressively. In other recent clinical trials in recurrent ovarian cancer, only limited clinical responses were obtained in the treated patients, and even those were only in a small percentage of patients (for example, 18-28% of those treated).
DCVax(R)-L is a groundbreaking personalized vaccine that takes a patient's own immune cells and trains them in the laboratory to attack the biomarkers from that patient's own tumor cells. The 10-day manufacturing process produces several years of personalized vaccine for the patient, making DCVax(R)-L an "off-the-shelf" product for that patient throughout the treatment period, and enabling the product cost to stay within a range similar to existing cancer drugs. DCVax(R)-L is administered as a simple injection under the skin, like a flu shot, and is not toxic as chemotherapies are. In clinical trials with NWBT's DCVax(R) vaccines for other cancers, such as DCVax(R)-Brain for Glioblastoma multiforme brain cancer, more than 80% of treated patients have shown significant responses to those vaccines.
"We are very pleased with these initial findings for our DCVax(R)-L for ovarian cancer. Seeing not only stable metastatic lesions, but also metastatic lesions that shrink or disappear is very encouraging in ovarian cancer, as there is little, if anything, to help patients with the bleak prognosis of recurrent ovarian cancer," stated Dr. Lisa Beth Ferstenberg, Chief Medical Officer of the Company. "We look forward to more comprehensive results as the trial progresses."
The NWBT trial consists of two consecutive stages, and combines multiple treatment modalities in a state-of-the-art design based on the latest research findings and literature. Each stage begins with a pre-conditioning regimen using just one or two treatment cycles of certain commonly used agents, to help improve the immune environment and to help clear the path for DCVax(R)-L to perform. Following the pre-conditioning regimen in the first stage, the patients receive DCVax(R)-L three times, spaced two weeks apart. Following the pre-conditioning regimen in the second stage, patients enter a sequential study in which they receive one dose of their own "killer" T cells (which have been primed or "educated," by exposure to that patient's DCVax(R)-L vaccine, to attack that patient's tumor), and one or several further doses of DCVax(R)-L (depending on the amount of vaccine that could be made from the patient's tumor tissue).
About Northwest Biotherapeutics
Northwest Biotherapeutics is a 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: dendritic cell-based vaccines, and therapeutic antibodies. The Company's lead product candidates, in addition to DCVax(R)-L, are:
-- DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has entered into a large Phase II clinical trial; and
-- DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is ready to enter a Phase III clinical trial cleared by the FDA.
For further information, please visit the company web site at http://www.nwbio.com.
The Company also has a robust pipeline of additional products cleared by the FDA for early stage clinical trials in five other cancers beyond brain, prostate and ovarian cancers.
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 as the company's ability to raise additional capital, risks related to the company's ability to enroll patients in its Phase I/II clinical trial of DCVax(R)-L in recurrent, metastatic ovarian cancer, or its Phase II clinical trial of DCVax(R)-Brain in Glioblastoma Mulitforme, and complete those trials on a timely basis, the uncertainty of the clinical trials process, the timely performance of third parties, and whether DCVax(R)-L and DCVax(R)-Brain will demonstrate safety and efficacy. 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.
CONTACT: Alton Boynton of Northwest Biotherapeutics, Inc., +1-240-497-9021
Web site: http://www.nwbio.com/
Ticker Symbol: (NASDAQ-OTCBB:NWBO),(NASDAQ-OTCBB:NWBO)
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Posted: December 2008