, May 27, 2014
/PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided a summary of initial data to date in its ongoing Phase I/II clinical trial of DCVax-Direct for all types of inoperable solid tumors. The Company reported that over 50% of the patients who have completed at least half of the 6 treatments in the trial are already showing preliminary signs of cancer cell death, tumor shrinkage and/or stabilization (i.e., stopping the progression) of their advanced cancer.
Further information will be available at the Company's exhibit booth at the upcoming ASCO conference. The Company also plans to conduct a conference call to discuss the initial preliminary data.
The Company's Phase I/II trial of DCVax-Direct is treating patients with advanced, inoperable cancers involving multiple metastases (including metastatic colon cancer, pancreatic cancer, sarcoma, melanoma and others). Although these patients have such advanced metastatic disease, only one tumor is being injected in each patient because the current trial is a first-in-man study. In future studies, the Company plans to inject DCVax-Direct into multiple tumors in each patient.
The Phase I portion of the trial includes 36 patients. To date, 19 patients have completed at least half of the 6 treatments with DCVax-Direct, which are spread over 8 months. None have yet completed all 6 treatments.
Among the 19 patients who have received at least half of the 6 treatments, 11 patients have already shown some preliminary positive responses to the treatments, including the following:
- 8 of the 11 patients have shown signs of tumor necrosis (cell death) and immune cell infiltration, as well as stabilized disease that has stopped progressing, following the injections of DCVax-Direct.
- For all of these 8 patients, biopsies indicated substantial to extensive tumor necrosis, as well as substantial accumulations of immune cells infiltrating into and around the patients' tumors, following the DCVax-Direct injections.
- For 6 of these 8 patients, imaging scans also indicated either tumor shrinkage or no disease progression following the DCVax-Direct injections.
- For the other 2 of these 8 patients, imaging scans seemed to indicate some enlargement of their tumors. However, the needle biopsies revealed that the tumor was filled with necrosis (dead tumor cells) and infiltrating immune cells, as noted above. In addition, these patients have reported significant improvement in their physical condition and clinical symptoms.
- The other 3 of the 11 patients have shown stabilized disease, with no growth in their advanced and aggressive tumors following the DCVax-Direct injections, but have not yet shown definitive necrosis or infiltration of immune cells into their tumors.
Among the remaining 8 of the 19 patients who have received at least half of the 6 injections in the trial:
- 1 of these 8 patients requires more data before a preliminary assessment can be made;
- 7 of these patients have shown progression of their disease.
The Phase I/II DCVax-Direct clinical trial includes a total of 60 patients: 36 in the Phase I portion and 24 in the Phase II portion. The DCVax-Direct trial began treating its first patients in Q3 of last year.
As is often the case with first-in-man studies, the Company's DCVax-Direct trial was required, as a regulatory matter, to proceed slowly until safety considerations could be assessed. The Company was required to treat just one patient with at least 2 of the 6 treatments in the overall regimen, then wait 2-3 weeks before treating the next single patient in the same way, and so on, treating just one patient at a time.
By March, the Company was permitted to begin enrolling without such pacing limitations. In the period between March and May, most of the remaining slots in the 36-patient Phase I trial have been enrolled or completed screening. (Enrollment occurs after both the screening and the product manufacturing have been completed for that patient.)
The DCVax-Direct treatment regimen in the clinical trial includes a total of 6 injections: initially at Day 0, Day 7 and Day 14, followed by injections at Week 8, Week 16 and Week 32.
"We are excited to already begin seeing some initial positive responses in such a substantial percentage of the DCVax-Direct patients," commented Linda Powers, CEO of NW Bio. "We had anticipated potentially seeing responses within a couple of months after treatment, but seeing such responses while these patients are still only part way through their treatment is especially encouraging."
"It is also exciting to see these initial responses in diverse cancer types, and in patients with very advanced, inoperable metastatic cancers especially with only one tumor being injected with DCVax-Direct in the current trial," Ms. Powers continued. "Of course, we must emphasize that it is still early in the DCVax-Direct trial, and the results may become greater or lesser as more data is obtained. However, there are no effective treatments for these metastatic cancer patients today, and we hope that DCVax-Direct will be able to offer an important new treatment option for these patients."
Dr. Marnix Bosch, Chief Technical Officer of NW Bio, noted, "As a drug developer and a scientist, it is exciting to see this early DCVax-Direct progress indicating the induction of anti-tumor immune responses. We are eagerly looking forward to seeing the ongoing data."
DCVax-Direct is a personalized immune therapy for all types of inoperable solid tumor cancers, using dendritic cells (the master cells of the immune system) to mobilize the full immune system to attack the patient's cancer. DCVax-Direct is administered by direct injection into the patient's tumors, and can reach tumors in virtually any location in the body (with image guidance for interior locations).
Further information about DCVax-Direct and the Phase I/II clinical trial will be available at the Company's exhibit booth at the upcoming ASCO conference, and Company personnel will be available to discuss this information. In addition, the Company will be presenting a poster describing the DCVax-Direct clinical trial. The Company encourages anyone attending ASCO to visit the Company's exhibit booth.
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 United States and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain cancer) patients outside the clinical trial.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients 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 "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," 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 risks related to the Company's ongoing 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, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. 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.
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