Exceptional Survival Data, Lower Costs Key to the Competitive Advantage of DCVax(R) - Northwest Biotherapeutics' Vaccine for Multiple Cancers

Comprehensive report by recognized Pharma and Biotech Analyst Dr. Navid Malik cites 'striking data on survival' and 'batch manufacturing at low cost' as key elements in DCVax's 'competitive advantage' in the 'personalized cancer vaccine revolution.'

Jun 07, 2010, 15:28 ET from Northwest Biotherapeutics, Inc.

BETHESDA, Md., June 7 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT") (OTC Bulletin Board: NWBO), developer of the DCVax® personalized cancer vaccine, today announced the release of a new detailed report by Pharmaceuticals and Biotech Analyst Dr. Navid Malik of the London-based Matrix Group.

As part of an in-depth review of the history and competitive landscape of what he calls the "cancer vaccine revolution," Dr. Malik concludes that "NWBT has generated some of the most striking data on survival and delayed time to progression in both brain cancer and prostate cancer that we have seen from any product in the market or in clinical development." Citing both "high dendritic cell purity" and "the single-batch bulk manufacturing process," as "key advantages of NWBT's technology which have not yet been appreciated by the market," he concludes that this gives DCVax® a "competitive advantage…versus virtually all of the other personalized cancer vaccine players."

A brief summary of the key findings in Dr. Malik's 40 page Report is attached, and upon your request we can send you by email or otherwise the 1 MB PDF file of the full text of the Report, with all of the supporting analysis.

Linda Powers, Chairman of the Board of NWBT stated "We are grateful to Matrix for undertaking such a comprehensive analytical review of the increasingly active and promising cancer vaccine field. We are gratified that their conclusions support what NWBT has worked to achieve over the last 10 years: compelling late stage clinical trial results at major institutions for several different cancers."

Looking to the future, Powers continued, "Now it is up to us to take what we have accomplished, spread the word, and execute on the competitive and medical promise which Matrix has identified. With the tremendous unmet worldwide need for better cancer treatments – ones that are non-toxic, more effective and less costly -- immune therapies are well equipped to meet that challenge."

Other key conclusions from Dr. Malik's newly released Report include:

  • The survival data seen to date with the NWBT technology in prostate cancer has been exceptional. While Dendreon's Provenge has demonstrated a median survival in pivotal trials of 25.9 months, NWBT's DCVax®-Prostate has demonstrated median survival in Phase I/II studies of 38.7 months, with 64% of patients surviving at three years (Provenge three year survival: 34%). DCVax®-Prostate has been cleared by FDA to begin a US Phase Ill clinical trial.
  • In Glioblastoma multiforme (GBM), the survival rates in trials with NWBT's DCVax® thus far have been highly impressive - earlier Phase I and Phase I/Il trials have demonstrated a median survival of 36.4 months versus 14.6 months with standard of care (including surgery, radiation and chemotherapy with Temodar). What is particularly significant is the fact that over 68% of patients live beyond two years compared to 27.2% seen with standard of care.
  • If DCVax®-Brain and DCVax®-Prostate are successful in their respective pivotal trials and eventually approved, then we see both products as having potential blockbuster sales. More importantly there are other key advantages to NWBT's technology which have not yet been appreciated by the market. This includes clear manufacturing advantages offered by NWBTs single-batch bulk manufacturing process (which will be automated in the future using a proprietary, patent protected manufacturing process), and by its high dendritic cell purity of the final vaccine and crucially what we believe is a stronger patent position for DCVax®-Prostate than for Provenge outside of the US.

About Northwest Biotherapeutics

Northwest Biotherapeutics (OTCBB: NWBO) is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines and therapeutic antibodies, with a concerted focus on the development of its dendritic cell-based immunotherapy. The Company's lead clinical trial is a 240 patient double blind, randomized, placebo controlled Phase II trial in GBM. Northwest Biotherapeutics has also received clearance from the FDA for a 600+ patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company also conducted a Phase I/II trial with DCVax for recurrent metastatic ovarian cancer. The Company's second technology platform, involving antibodies to CXCR4, is at the late pre-clinical development stage. Further Company, product and clinical site information may be accessed online at www.nwbio.com.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax®-Brain 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 uncertainties about 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.

Summary Of Matrix Group Report On Cancer Vaccines And Northwest Biotherapeutics: "Competitive Advantage In Cancer Vaccines"

Northwest Biotherapeutics (NWBT) is a US cancer vaccine maker, which, like Dendreon, operates in the personalised immunotherapy cancer space using cutting-edge dendritic cell technology. NWBT currently has two vaccines at or near late-stage development in glioblastoma (brain cancer) and prostate cancer. To date the survival data from using the NWBT technology in prostate cancer has been exceptional. If DCVax®-Brain and DCVax®-Prostate are successful in their respective late stage trials and eventually approved, we see the potential for blockbuster sales for both products.

  • NWBT is currently conducting a Phase II clinical trial (powered to serve as a pivotal trial) in Glioblastoma multiforme (brain cancer) in the US, which is set to resume recruiting once the company has completed a further round of financing. As the number of clinical sites within the trial increases, we see the potential for the trial to be halted at the time of interim data analysis based on strongly positive data. This should permit the launch of the first product for brain cancer in the US within the next three years.
  • To date the survival data from using the NWBT technology in prostate cancer has been exceptional. Dendreon, which has a prostate cancer vaccine, Provenge, recently approved by FDA, has demonstrated median survival in pivotal trials of 25.9 months. NWBT's DCVax®-Brain has, however, demonstrated survival data in Phase I/II studies of 38.7 months, with 64% of patients surviving at three years (Provenge's three-year survival rate is 34%). DCVax®-Prostate has been cleared by FDA to begin a Phase III clinical trial, which we believe may serve as the pivotal trial.
  • In glioblastoma, survival rates seen thus far with DCVax®-Brain are impressive – previous Phase I and Phase I/II trials have demonstrated a median survival of 36.4 months vs. standard of care (including Temodar) of 14.6 months. More than 69% of patients live beyond two years compared to 26% with standard of care.
  • If DCVax®-Brain and DCVax®-Prostate are successful in their respective late stage trials and eventually approved, we see the potential for blockbuster sales for both products. More importantly, however, are other key advantages of NWBTs technology, which have not yet been appreciated by the market: the single-batch bulk manufacturing process (which enables far lower pricing than Dendreon's, and attractive margins); the high dendritic cell purity of the final vaccine (which enables simple intra-dermal injection like a flu shot, and enhances the vaccine's function); and, crucially, DCVax®-Prostate's patent position (which we believe is stronger than Provenge's patents outside the US).

The most urgent priority for the company is to restructure its balance sheet. We believe that the company is currently addressing this issue.

SOURCE Northwest Biotherapeutics, Inc.



RELATED LINKS

http://www.nwbio.com