December 13, 2011 -- On December 12th 2011 Life Research Technologies GmbH, the clinical subsidiary of CELLMED and sponsor of the phase I/IIa trial of PROCURE® in ovarian cancer, received a positive ruling on the interim safety report of PROCURE® from the ethics committee.
PROCURE® is CELLMED’s lead product, a patented innovative immunotherapy for the treatment of ovarian cancer and other solid tumors. Using a unique double loading of dendritic cells with the universal tumor antigens Survivin and TERT the goal of the treatment with PROCURE® is to delay or ultimately prevent tumor recurrence. Two patients have successfully received all eight vaccines. As stipulated by the ethics committee, following the second vaccination of the third patient all side effects recorded so far were discussed by the Data Safety Management Board with its chairman Univ.-Prof. Dr. Michael Krainer. As no safety risk whatsoever was found, it was recommended to continue the clinical trial without any objections. After a further appraisal of the interim report by the review board of the ethics committee they ruled in favour of continuing the study.
“We are very pleased that all our vaccinated patients are doing well and that the hoped for reactions such as fever and skin redness were present in all three patients within days of vaccination. These reactions are indicators of a successful stimulation of the immune system”, says Prim.
Univ.-Doz. Dr. Martin Imhof, the medical supervisor of the clinical trial phase I/IIa. “With this positive intermediate result we have taken an important hurdle on the path to success for the treatment of ovarian cancer with our vaccine PROCURE®. We are highly motivated to plan our further clinical development program. We expect to complete the recruitment for phase I/IIa by the summer of 2012 and plan to begin with trial phase IIb of our study by late 2012” adds Dr. Karl Krista, who, as of November 23rd 2011, heads the CELLMED as Chief Executive Officer.
“A financing round of EUR 17.8m is needed to fund the company until the completion of results for phase IIb in the year 2015.”
About CELLMED Research GmbH
CELLMED Research GmbH, together with its subsidiaries “Life Research Technologies GmbH” and “Cellpro Danube GmbH”, constitutes an Austrian life science group founded in 2006. Its main focus is on the development and legal approval of its lead product PROCURE®, a patented autologous cellular immunotherapy for the treatment of ovarian cancer and other solid tumors. The uniqueness of PROCURE® is based on the double loading of dendritic cells with the universal tumor antigens Survivin and TERT. This is expected to lead to an increased immune response. The goal of the treatment with PROCURE® is to delay or ultimately prevent tumor recurrence. CELLMED Research GmbH Dr. Karl Krista CEO karl.krista@cellmed.at www.cellmed.at Magnesitstraße 1 3502 Krems-Lerchenfeld Austria T +43 2732 70 51 20
