Exceeds Projections, With 17 Active Clinical Trial Sites
BETHESDA, Md., Oct. 6, 2011 /PRNewswire/ -- Northwest Biotherapeutics (OTC.BB: NWBO) (NORTHWEST BIO) today announced that it has exceeded its Q3 projection of 15 clinical trial sites by the end of the quarter, with 17 sites at major medical institutions across the U.S. now open and active where patients can enroll in the Company's ongoing clinical trial of DCVax® immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The Company likewise exceeded its Q2 projections, as previously announced.
The Company said it is continuing to add clinical trial sites in the U.S. and Europe. The Company expects to have 25 sites open and active by the end of the next quarter (Q4), with further growth expected into 2012. Open and active trial sites are listed on the U.S. Government's website, www.clinicaltrials.gov, and on NORTHWEST BIO's website www.nwbio.com
The Company's clinical trial site expansion reflects growing interest from both physicians and patients, and a growing awareness of the positive data from the Company's prior clinical trials for GBM brain cancer. In those trials, patients who received DCVax® showed a median survival of 3 years compared with median survival of 14.6 months for patients who receive standard of care (surgery, radiation and chemotherapy). Patients who received DCVax® also experienced a substantially longer time to tumor recurrence: a median of 2 years, compared with 6.9 months in patients who received standard of care. DCVax® was well-tolerated, with no toxic side effects.
NORTHWEST BIO's current clinical trial for GBM brain cancer also offers a key difference from other immune therapy trials currently under way. The NORTHWEST BIO trial is a double-blind randomized controlled trial, with a "treated" group and a "control" group, as is required for late stage clinical trials. However, unlike other current immune therapy trials for cancer, the NORTHWEST BIO trial has been carefully designed so that it provides an opportunity for all patients in the "control group" to "cross over" and receive the DCVax® immune therapy after a certain point is passed. As a result, the NORTHWEST BIO trial design will not only provide randomized, placebo-controlled data, it will also allow all patients in the trial to ultimately receive the DCVax® treatment -- including the patients who are assigned to the "control group." Physicians and patients are expressing strong interest and support for this trial design.
As part of NORTHWEST BIO's program to increase the visibility of its progress, it also announced today that it has entered into an agreement to have company information made available via Standard & Poor's Market Access Program, an information distribution service that enables subscribing publicly traded companies to have corporate information disseminated to users of Standard & Poor's Market Scope Advisor, used by more than 100,000 investment advisors. The first step under this program is a basic listing of NORTHWEST BIO in the Daily News section of Standard Corporation Records, a recognized manual for secondary trading in up to 38 states under their Blue Sky Laws, thereby qualifying NWBO for trading in those states.
Standard and Poor's also makes available a weekly updated Stock Report on Company initiatives and strategy, as well as basic stock-related and financial information. The first Stock Report on NORTHWEST BIO is expected to be available through the Market Scope Advisor public website at www.advisorinsight.com by mid-October following completion of the initial Report and review by the Company, as well as through other distribution channels.
Linda Powers, CEO of NORTHWEST BIO, commented that "It is gratifying to see that the expanded management team put in place in June is moving the GBM clinical trial forward at an accelerating rate, while taking important steps toward strengthening our investor and media outreach."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis in both the US and Europe. The Company has a broad platform technology for dendritic cell-based vaccines. The Company's lead clinical trial is a 240-patient Phase II trial in newly diagnosed Glioblastoma multiforme ("GBM"), the most aggressive and lethal brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in multiple other cancers. The Company has also conducted a Phase I/II trial with DCVax® for recurrent metastatic ovarian cancer. For further information about clinical sites and about the Company, please visit the Company's web site at www.nwbio.com.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax® and future clinical trials, 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 clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. Additional information on these and other factors, including Risk 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 from 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.
SOURCE Northwest Biotherapeutics