Munich Biotech Reports Additional Positive Data From MBT- 0206 Phase I Trial

26-Mar-2004

Munich Biotech AG has announced details of results presented during a recent congress of clinical investigators, reporting on results of Phase I trials of MBT-0206 in cancer patients. New results have indicated that patients continuing with MBT-0206 beyond the trial period on compassionate grounds show quality of life improvements, stabilization and, in some cases, tumor regression. In addition, neither increasing cytotoxic side-effects nor drug resistance were recorded. This profile differentiates MBT-0206, a novel anti-neovascular therapy, from most other chemotherapies. MBT-0206 acts via a novel mechanism, specifically targeting tumor endothelial cells and inhibiting vascularization of the tumor. MBT-0206 is the first compound in its class taking advantage of this innovative mode of action. In the Phase I trials, MBT-0206 was extremely well tolerated with no significant side effects. As many patients experienced a reduction of the pain associated with end-stage cancer at the very onset of treatment, 8 patients have remained on the treatment after the trial terminated. Results from these patients show both tumor stabilization and in 4 patients a partial response, which in one case led to the tumor being removed via surgery with the patient in remission. Typically, cytotoxic treatments have a benefit only at the onset of treatment and this declines as treatment continues with unpleasant side effects taking over. In addition, many tumors develop resistance to the cytotoxic compound. Results with MBT-0206 show neither of these down sides. Data has now been gathered from a total of five Phase I trials that have enrolled over 150 patients with different types of cancer, including breast, prostrate, colorectal and melanoma. Commenting on the results, Dr. Karsten Ridwelski, lead investigator from Magdeburg Hospital, Germany said: "For extremely ILL cancer patients, many of whom are in extreme pain, being able to work on a clinical trial that has offered amazing and unexpected positive results has been very rewarding for myself, the nursing staff and, of course, the patients. MBT-0206 seems to be an exceptional drug without the usual drawback of unpleasant side effects. Normally chemotherapy gives reduced benefits throughout the time of treatment and side effects increase dramatically and these can often be more unpleasant and unbearable than the disease itself. If MBT-0206 makes it through future clinical trials to market then it will be a very important new drug to treat cancer." Commenting on the trial, Dr Kurt Naujoks, CEO Munich Biotech said: "The positive efficacy outcomes of the Phase I trial are very encouraging. The beneficial effects have astonished us and are quite different from those seen with most cytotoxic drugs. News of these positive outcomes in the oncology community has led to approaches from clinicians requesting access to MBT-0206 for patient treatment. MBT-0206 looks to be a promising and important drug for both first-line and second-line therapy, both in mono therapy regimes and in combination with other drugs." Currently phase II clinical trials are ongoing with MBT-0206 in metastatic breast cancer and advanced pancreatic cancer.

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