BETHESDA, Md., Dec. 23 (OTC Bulletin Board: NWBO; AIM: NWBT and NWBS) Northwest Biotherapeutics, Inc.("NWBT") today announced encouraging data on clinical responses in the firsttwo case reports of patients who have completed the Company's Phase I/IIclinical trial with DCVax(R)-L personalized cancer vaccine for recurrent,metastatic ovarian cancer.
This trial is ongoing, and is treating "no option" patients who havealready been treated with most or all major drugs currently available forrecurrent, metastatic ovarian cancer (including carboplatin, paclitaxel,docetaxel, abraxane, gemcitabine and topotecan), and whose cancer has stillcontinued to progress. In other recent clinical trials testing various drugsand drug combinations for recurrent ovarian cancer, the treated patients havegenerally attained less than 3 or 4 months without progression of theircancer, and have experienced serious side effects (including gastro-intestinalperforation, a life-threatening condition).
In NWBT's trial, the two patients who have received treatment attained 8months and 6 months without progression, respectively. Each of these NWBTpatients 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 followingthe treatment regimen -- either by shrinking somewhat (20-25%), or byremaining the same size and not growing, or by disappearing. The patients didnot experience any toxicity or debilitating side effects.
Metastatic ovarian cancer poses a particularly serious and urgent unmetmedical need. In most patients, the disease is not discovered until is italready late stage, because ovarian cancer typically causes little or nosymptoms until it is late stage. When this cancer has metastasized, as in thecase of the no-option patients in NWBT's trial, the cancer usually progressesrapidly and aggressively. In other recent clinical trials in recurrentovarian cancer, only limited clinical responses were obtained in the treatedpatients, and even those were only in a small percentage of patients (forexample, 18-28% of those treated).
DCVax(R)-L is a groundbreaking personalized vaccine that takes a patient'sown immune cells and trains them in the laboratory to attack the biomarkersfrom that patient's own tumor cells. The 10-day manufacturing processproduces several years of personalized vaccine for the patient, makingDCVax(R)-L an "off-the-shelf" product for that patient throughout thetreatment period, and enabling the product cost to stay within a range similarto existing cancer drugs. DCVax(R)-L is administered as a simple injectionunder the skin, like a flu shot, and is not toxic as chemotherapies are. Inclinical trials with NWBT's DCVax(R) vaccines for other cancers, such asDCVax(R)-Brain for Glioblastoma multiforme brain cancer, more than 80% oftreated patients have shown significant responses to those vaccines.
"We are very pleased with these initial findings for our DCVax(R)-L forovarian cancer. Seeing not only stable metastatic lesions, but alsometastatic lesions that shrink or disappear is very encouraging in ovariancancer, as there is little, if anything, to help patients with the bleakprognosis of recurrent ovarian cancer," stated Dr. Lisa Beth Ferstenberg,Chief Medical Officer of the Company. "We look forward to more comprehensiveresults as the trial progresses."
The NWBT trial consists of two consecutive stages, and combines multipletreatment modalities in a state-of-the-art design based on the latest researchfindings and literature. Each stage begins with a pre-conditioning regimenusing just one or two treatment cycles of certain commonly used agents, tohelp improve the immune environment and to help clear the path for DCVax(R)-Lto perform. Following the pre-conditioning regimen in the first stage, thepatients receive DCVax(R)-L three times, spaced two weeks apart. Followingthe pre-conditioning regimen in the second stage, patients enter a sequentialstudy in which they receive one dose of their own "killer" T cells (which havebeen 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 ofDCVax(R)-L (depending on the amount of vaccine that could be made from thepatient's tumor tissue).
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developingimmunotherapy products that treat cancers more effectively than currenttreatments, without toxicity, on a cost-effective basis. The Company has twobroad platform technologies: dendritic cell-based vaccines, and therapeuticantibodies. The Company's lead product candidates, in addition to DCVax(R)-L,are:
-- DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment ofGlioblastoma multiforme, which has entered into a large Phase II clinicaltrial; and
-- DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatmentof hormone independent non-metastatic prostate cancer, which is ready to entera Phase III clinical trial cleared by the FDA.
For further information, please visit the company web site athttp://www.nwbio.com.
The Company also has a robust pipeline of additional products cleared bythe 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 areforward-looking statements within the meaning of the Private SecuritiesLitigation Reform Act of 1995. Words such as "expects," "believes,""intends," and similar expressions are intended to identify forward-lookingstatements. Actual results may differ materially from those projected in anyforward-looking statement. Specifically, there are a number of importantfactors that could cause actual results to differ materially from thoseanticipated, such as the company's ability to raise additional capital, risksrelated to the company's ability to enroll patients in its Phase I/II clinicaltrial of DCVax(R)-L in recurrent, metastatic ovarian cancer, or its Phase IIclinical trial of DCVax(R)-Brain in Glioblastoma Mulitforme, and completethose trials on a timely basis, the uncertainty of the clinical trialsprocess, the timely performance of third parties, and whether DCVax(R)-L andDCVax(R)-Brain will demonstrate safety and efficacy. Additional informationon these and other factors, which could affect the company's results, isincluded in its Securities and Exchange Commission ("SEC") filings. Finally,there may be other factors not mentioned above or included in the company'sSEC filings that may cause actual results to differ materially those projectedin any forward-looking statement. You should not place undue reliance on anyforward-looking statements. The company assumes no obligation to update anyforward-looking statements as a result of new information, future events ordevelopments, except as required by securities laws.
SOURCE Northwest Biotherapeutics, Inc.