Did anyone see/post today's alert from Micro Cap Daily
I like the fact that they mentioned DCVAX Direct.
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) held its annual shareholder virtually this year due to covid-19 and CEO Linda Powers, discussed the projected schedule for reaching data lock, unblinding and reporting of top line data from its 331-patient Phase 3 trial of DCVax®-L for Glioblastoma brain cancer.
According to NWBO CEO Linda Powers “the current estimate of public disclosure of top line data would range from the end of June to early July.
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a clinical stage biotechnology company focused on the development of personalized immunotherapy for a broad range of solid tumor cancers. The company has over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. The Company is led by Linda Powers, a successful entrepreneur who worked for many years in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011.
NWBO platform technology is DCVax, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. Northwest lead product is DCVax-L for Glioblastoma multiforme (“GBM”), the most lethal form of primary brain cancer. The Company has completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below. Northwest is currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is “Progression Free Survival,” meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures. The trial is under way at 51 sites (medical centers) across the US. The sites and the eligibility criteria are listed in the profile of the trial at ClinicalTrials.gov. The trial is also under way in Europe. The lead site is Kings College Hospital in London. Approximately 30 trial sites are also in varying stages of preparation in the U.K. and Germany.
DCVax® – Direct offers a potential new treatment option for the wide range of clinical situations in which patients’ tumors are considered “inoperable” because the patient has multiple tumors, or their tumor cannot be completely removed, or the surgery would cause undue damage to the patient and impair their quality of life. DCVax-Direct is administered by direct injection into a patient’s tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. DCVax-Direct can also be injected into tumors in virtually any location in the body: not only tissues at or near the surface of the body but also, with ultra-sound guidance, into interior tissues. Northwest is currently conducting a 60-patient Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The trial is under way at MD Anderson in Houston, TX and MD Anderson in Orlando, FL, with additional sites in varying stages of preparation. The Phase I stage of the trial involves dose escalation, testing 3 different dose levels of DCVax-Direct, and confirmation of the optimal dose.
DCVax®-Prostate is designed specifically for late stage, hormone independent prostate cancer. Such cancer involves the spread of micro-metastases beyond the prostate tissue. In most patients, there is no focal tumor which can be surgically removed and used to make lysate, or into which dendritic cells can be directly injected. Instead, the cancer cells are diffuse. We have developed a DCVax product line using a particular proprietary antigen — PSMA (Prostate Specific Membrane Antigen) — which is found on essentially all late stage (hormone independent) prostate cancer. The PSMA is produced through recombinant manufacturing methods, and is then combined with the fresh, personalized dendritic cells to make DCVax-Prostate.
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