Northwest Biotherapeutics initiates Phase III trial of DCVax-L Germany

Northwest Biotherapeutics initiates Phase III trial of DCVax-L Germany

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Northwest Biotherapeutics (NASDAQ: NWBO) immune therapies (NW Bio), a biotechnology company which develops personalized DCVax® for solid tumor cancers, today announced that it has initiated the trial of DCVax-l Phase III in Germany. The first site to open in Germany was a medical center in Dresden, which was launched in late May. The Company now expected initiations of full-day site to other 3 sites during June and 4 other sites in July.

To date, the trial has been registering in parallel to the United States and Europe (UK), as previously announced. The first German site is now beginning to screen patients for enrollment purposes, and additional German sites will start doing their regular following initiations (patients can get information about test sites by contacting the Company at patients@nwbio.com ).

The process of launching a clinical trial site (ie complete the steps necessary to enable a website to attend, and open enrollment for a clinical trial) generally takes about 6 months for each site in the United States. In Germany, there are several additional steps involved beyond that of the United States. The process can be repeated several clinical trials sites (ie medical centers) in parallel, but the steps at each site must be done sequentially.

In the United States, the steps needed to launch a site include the following.

• The first step is the "qualifying site," in which the two documents and on-site assessments are made (personnel, facilities, past clinical trial experience in both the institution and staff, etc.) to determine the medical center's capacity to serve as site in the clinical trial. This can take a month to organize and complete.
• the second stage is the review and approval of the clinical trial and all related documents (forms of patient's specific consent, data collection, etc.) by the medical center "Institutional review Board (IRB). "In many medical centers, the IRB meets once a month. The trial package must be submitted weeks in advance, and review of the IRB, questions, other comments, a new consideration and decision of the IRB generally take 2-3 months.
• the third step is the negotiation of a contract ( "clinical trial Agreement") with the legal department of the medical center and the clinical trial budget with the budget department of the medical center. The terms and contract budgets can vary greatly between medical centers in the same clinical trial. This process usually takes about two months.
• The fourth step is the "Site Initiation." This involves organizing and carrying a full day, detailed, joint training of all personnel who will be involved in the process: for example, neurosurgeons, neuro-oncologists, head of the hospital pharmacy , pathologists, radiologists, nurses and others. The deadline for organizing the joint training with so many players on the same day is usually important. The training includes all aspects of the test, including patient eligibility criteria and procedures, treatment procedures, testing procedures and monitoring, data collection, etc.

Each of the above steps must be completed successfully before the next step on a site can be undertaken (because the sites are not the contrary), and all steps must be completed success before a clinical trial can open for registration on this site. This long process must be performed on each site individually for each site participating in a clinical trial.

In Germany, for DCVax-L clinical trial, significant additional steps must be performed in addition to steps for the US described above sites.

• Each clinical trial site must obtain a regulatory license to collect tumor tissue and using the local regulatory authorities in the jurisdiction where the trial site (ie medical center ) is located. The local authority requirements for these licenses vary. The preparation of the appropriate application package to local regulators, and review the decision and issuance of tumor collection licenses by regulators, takes a few months.
• Similarly, each clinical trial site must obtain a license regulations for the collection of blood apheresis (collecting immune cells) from the local regulatory authorities in the jurisdiction where the trial site is located . Local regulators with authority over leukapheresis licenses may be different from local regulators with authority on licensing for collection of tumor tissue. The preparation of the appropriate application package to local regulators, and review the decision and issuance of apheresis collection licenses by these regulators will take a few months. Fortunately, unlike other stages of trial site initiation clinic, the tumor collection and apheresis license license can be run in parallel, so that both licenses can potentially be completed simultaneously within ' a couple of months.
• In several clinical trial sites in Germany, several separate commercial contracts should be traded. Separate contracts must be negotiated with the radiology department and the apheresis service, in addition to the clinical trial agreement described above. The requirements and conditions of these additional contracts vary from site to site, and must be negotiated individually.

As noted above, in Germany, these steps are in addition to the steps described above, which take about six months to allow the sites to open a trial in the United States. Therefore, the process is a bit more in Germany.

"We are delighted to have Phase III trial DCVax-L open for registration in Germany," commented Linda Powers, CEO of NW Bio. "It took an important teamwork to accomplish the necessary steps for these sites. However, we are now ready to launch a large body of clinical trial sites throughout Germany, and we have built a solid foundation for our clinical programs in Germany. "