12 Apr, 2012, 08:30 ET
BETHESDA, Md., April 12, 2012 /PRNewswire/ -- Northwest Biotherapeutics (OTC Bulletin Board: NWBO) (NW Bio) announced today that it is partnering with King's Health Partners to both manufacture and deliver a new treatment for patients with brain cancer as part of its ongoing 240-patient clinical trial for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. Specialists at King's College London will manufacture NW Bio's immune therapy treatment, DCVax®, for the clinical trial which will take place and involve brain cancer patients at King's College Hospital NHS Foundation Trust. Both institutions are part of King's Health Partners, a pioneering collaboration which brings together one of the world's leading research-led universities with three of London's most successful NHS Foundation Trusts to reduce the time it takes for research discoveries to become routine clinical practice.
The collaboration with King's College Hospital includes two important dimensions. One such dimension is enabling the Hospital to join NW Bio's ongoing, 240-patient randomized, controlled clinical trial for GBM brain cancer, which is currently under way at more than 30 clinical trial sites across the U.S. A second important dimension involves treatment of patients on a compassionate use basis, for those who do not fully meet the criteria to enroll on the clinical trial, but may benefit from the treatment. This compassionate use dimension will enable treatment of such patients to proceed while the clinical trial is ongoing.
The collaboration with King's College London involves support from the College for the manufacturing of NW Bio's DCVax® immune therapy. King's has a specialized "cGMP" (clean room) facility for processing of cell therapy products, and specialized scientific staff already experienced in working with such cell products. Under the collaboration, King's will make available its cGMP facility and experienced personnel to support the production of NW Bio's DCVax® products. The necessary regulatory permits are already in place for the production of DCVax® products at the facility, and Cognate BioServices, Inc., NW Bio's contract manufacturer, is conducting technology transfer and training in the proprietary DCVax® production processes. Cognate will manage and oversee the processing at King's (in addition to the production at Fraunhofer in Germany) on an ongoing basis, to ensure consistency and coordination.
This collaboration with the College brings important additional manufacturing capacity and flexibility for NW Bio's DCVax® products, without the need for any capital investment by NW Bio. Overall, this partnering with King's College Hospital and King's College London, as part of King's Health Partners, provides another solid foundation for NW Bio's programs in Europe, in parallel with NW Bio's partnership with the Fraunhofer Institute in Germany that was announced last year.
"We are pleased to be leading the way in bringing these novel immune therapies to patients in the UK," commented Dr. Keyoumars Ashkan, Consultant (i.e., Specialist) Neurosurgeon, Reader (Associate Professor) in Neurosurgery and Lead for Neuro-Oncology at King's College Hospital. "Brain cancers are some of the most lethal cancers, and there is a great need for new and better treatments. The positive data from the Phase I clinical trials in the U.S. were very encouraging in delaying disease progression and extending survival times, without significant toxic side effects. We are hopeful that similar results will be seen in the large, randomized clinical trial which we are now helping to bring to the UK."
Farzin Farzaneh, Professor of Molecular Medicine and head of cGMP cell product manufacturing at King's College London, said: "At King's, we are excited to be undertaking the manufacturing for the DCVax® immune therapies in the UK. Such immune therapies represent an exciting new class of products, and we are pleased to apply our expertise and facilities for cell therapy to help bring DCVax® immune therapies to the UK and Europe."
"We are excited about partnering with such prestigious institutions as King's College London and King's College Hospital," commented Linda Powers, CEO of NW Bio. "This partnership can help accelerate our brain cancer clinical trials, and also help extend lives through compassionate use treatments for other patients while the trials are ongoing. This partnership also expands our manufacturing capacity and flexibility in a highly cost effective way – a great arrangement both for patients and for our programs."
About King's Health Partners
King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering collaboration between King's College London, King's College Hospital, Guy's and St. Thomas' Hospitals, and South London and Maudsley NHS Foundation Trusts.
King's Health Partners is one of only five AHSCs in the UK and brings together an unrivalled range and depth of clinical and research expertise, spanning both physical and mental health. Our combined strengths will drive improvements in care for patients, allowing them to benefit from breakthroughs in medical science and receive leading edge treatment at the earliest possible opportunity. For further information, please visit the King's Health Partners website at www.kingshealthpartners.org.
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. The Company is developing dendritic cell-based vaccines. The Company's lead clinical trial is a 240-patient trial in newly diagnosed Glioblastoma multiforme ("GBM"), the most aggressive and lethal form of 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®-L 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, are included in the Company's 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
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