MUNICH BIOTECH REPORTS ADDITIONAL POSITIVE DATA FROM MBT- 0206 PHASE I TRIAL

Continued Tolerability, Quality of Life Improvement, Stabilization and Regression Seen in Cancer Patients on Extension Past Phase I Clinical Trials
  
Munich, March 25th, 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.  
- ENDS -Notes

1. About MBT-0206
MBT-0206 is an innovative intravenously administered anti-neovascular cancer agent for the treatment of all solid tumors and their metastases. It selectively targets and destroys tumor blood vessel endothelial cells that are activated and proliferating, resulting in tumor growth inhibition or regression. This is achieved by a combination of two active ingredients, EndoTAG™ and Paclitaxel both acting synergistically. EndoTAG™ is a proprietary lipid-based complex that is proven to function by selectively targeting angiogenic endothelial cells. This enables Paclitaxel, the well-known active ingredient in Taxol®, to destroy such cells. The combination of these two ingredients creates an effect not possible with either one of the substances alone, and establishes a new mechanism-of-action in cancer therapy. Due to its design, MBT-0206 is expected to be exceptionally well tolerated and to show a low organ and neurological toxicity. It is suitable for chronic treatment as neither induced tolerance nor immune reactions are expected. It could be used in tumors which are resistant to conventional treatment as the drug targets tumor blood vessel cells which do not develop resistance. Its complimentary mode-of-action makes it an ideal candidate for combination therapy with all conventional anti-tumor agents. MBT-0206 has advanced into phase II clinical trials in breast and pancreatic cancer. To date, over 150 patients have been treated with MBT-0206 in clinical trials.

2. Details of Ongoing MBT-0206 phase II studies 
Over 50 patients with advanced metastatic breast cancer will be enrolled for second- or third-line MBT-0206 monotherapy to further evaluate anti-tumor efficacy of MBT-0206 with administration of at least 8 cycles over 6 months.

A phase II study in metastatic pancreatic cancer patients is designed as first-line treatment administering MBT-0206 in combination with gemcitabine. A total of 70 patients will be enrolled in this study to evaluate survival benefit of this novel treatment regimen. It combines the innovative anti-neovascular agent MBT-0206 with the conventional chemotherapy gemcitabine with complimentary modes-of-action.

Both studies are initially designed as single-arm trials with the intent to add additional study arms after clearly defined milestones have been reached during the study.

3. About Munich Biotech AG - www.munichbiotech.com 
Munich Biotech AG is a privately owned, venture backed pharmaceutical Company. It has established a complete infrastructure of chemical, biological and clinical research staff of 70 professionals, who bring broad experience from the pharmaceutical industry. The Company has successfully developed a new generation of anti-cancer agents capable of targeting and destroying newly formed blood vessels. This opens up a host of new possibilities for diagnostic imaging and the treatment of solid tumors and metastases addressing unmet medical needs. 
 
Munich Biotech’s leading product, the anti-neovascular cytotoxic MBT-0206 has advanced into phase II clinical trials for various solid tumor indications. The second cancer agent in development, the camptothecin based MBT-0312, has started phase I clinical development. Because Munich Biotech’s products have an improved side-effect profile over most conventional chemotherapeutic agents, they can be used repeatedly. Munich Biotech holds a large number of granted and filed patents that protect its portfolio products. 


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At the company:Dr Kurt Naujoks, CEO, Munich Biotech AG, Munich
Phone: +49 (0)89 - 89 99 65-0 Mobile: +49 (0)172 - 8655944
Email: info@munichbiotech.com