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  • Cancer Vaccine Developer Advancing Multiple Phase 3 Clinical Trials 0 comments
    Feb 28, 2013 3:53 PM | about stocks: NWBO

    A recent Wall Street Journal article highlighted immunotherapy as one of six innovations that's poised to transform medicine. According to the article, "Few advances in cancer care are generating more enthusiasm than harnessing the power of the immune system to fight the disease."

    Therapeutic vaccines offer one of the most promising treatment pathways in cancer immunotherapy. GlobalData, a leading market research firm, expects the global market for therapeutic cancer vaccines to grow from $48.0 million in 2010 to $4.9 billion by the end of 2018, a compound annual growth rate of 78.1%.

    One immunotherapy company to watch is Northwest Biotherapeutics (NASDAQ: NWBO). NWBO uses dendritic cells, the starter engine of the immune system, in the formulation of its DCVax personalized cancer vaccines. Dendritic cells are extracted from the patient's body and loaded with tumor biomarkers or "antigens," creating a personalized therapeutic vaccine. In clinical trials, the Company's cancer vaccines demonstrated the ability to significantly extend both time to recurrence and survival, while providing a superior quality of life with no debilitating side effects when compared with current treatments such as chemotherapy.

    NWBO has two cancer vaccines in Phase III clinical trials, the final phase of testing before product approval. The Company is currently enrolling patients in a U.S. trial of DCVax-L to treat glioblastoma multiforme (GBM), the most lethal form of brain cancer. GBM is difficult to treat, as the tumor cells are resistant to conventional therapies, and most drugs cannot cross the blood-brain barrier. Most patients die within 15 months of diagnosis.

    To date, the clinical data for DCVax-L have shown a median survival of 33.8 months (and continuing) for patients treated with DCVax-L, with 9 of 19 patients still alive from 8-82 months after initial surgery. Most of these patients showed no evidence of tumor recurrence. NWBO is partnered with the Fraunhofer Institute, Europe's largest applied-research organization, and King's College London on the development of DCVax-L.

    NWBO also plans to initiate a Phase III trial of DCVax-Prostate in patients with late-stage prostate cancer. In an earlier clinical trial, DCVax-Prostate significantly increased the median survival time compared to chemotherapy and a key competitor, Dendreon's (NasdaqGS: DNDN) Provenge.

    A third product candidate, DCVax-Direct, addresses inoperable solid tumor cancers, which are cancers located in the tissues of the body. In pre-clinical animal trials, DCVax-Direct shrank and eliminated tumors not only at the injection site, but also on the opposite side of the body, indicating a systemic immune response. Additionally, when the animals were later injected with cancer cells, they didn't redevelop cancer. The Company plans to initiate Phase I/II human clinical trials of DCVax-Direct.

    NWBO offers investors a unique value proposition: a development-stage biotech company trading in the low $3 range, with two potential game-changing products in Phase III trials. Major recent accomplishments position NWBO for inflection: a new listing on Nasdaq, a comprehensive balance sheet clean-up that retired more than $36 million in debt, and the completion of a major new financing. To learn more about NWBO, watch our recent interview with CEO Linda Powers.

    Disclosure: The subject security is a client of RedChip Companies, Inc. RedChip Companies, Inc., employees and affiliates may have positions and affect transactions in the securities or options of the issuers mentioned herein. For full financial disclosures for all RedChip clients, please visit

    Stocks: NWBO
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