Northwest Biotherapeutics (NASDAQ: NWBO)(NW Bio), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that it has received a decision from the German regulatory agency (the Paul Ehrlich Institute, or PEI) under which the Company's Phase III clinical trial will be able to proceed in Germany after the Company makes three modifications, none of which affect the body of the trial or the bases for seeking product approval.
Two of the three modifications directed by the PEI involve modest textual matters, as follows:
One of the eligibility criteria for the trial is that patients must have adequate bone marrow function, since the immune cells with which DCVax is made are obtained through a leukapheresis blood draw. Currently the eligibility criteria set a general standard for bone marrow function, and identify a specific quantitative measure as an example ("e.g.,"). The PEI has directed that the "e.g.," be removed and that the same quantitative measure be made into a requirement rather than an example of the requirement.
Certain information about the risks and benefits of the DCVax treatment is currently contained in one of the key clinical documents (the Investigator's Brochure). The PEI has directed that the same information also be added into the trial Protocol document.
The third modification involves dropping an extra arm of the trial which is gathering data on patients who do not meet the eligibility criteria for enrollment in the body of the trial which will form the basis for any product approval decision.