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Positive Phase 1 Data - Phase 2 Trial For MediGene`s Novel Anticancer Therapeutic Being Prepared (PR Newswire)The biopharmaceutical company MediGene AG announced today that its wholly owned subsidiary MediGene, Inc. based in San Diego, USA, has submitted a final study report of its phase 1 clinical trial for G207, a novel anticancer therapeutic for the treatment of brain tumors to the FDA, the US American Food and Drug Administration.- Mar 06 7:03 AM ET


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Posted on: 03/06/2001

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Tuesday March 6, 7:03 am Eastern Time

Press Release

SOURCE: MediGene AG

Positive Phase 1 Data - Phase 2 Trial For MediGene's Novel Anticancer Therapeutic Being Prepared

Final Study Report for G207 to Treat Brain Cancer Submitted to the FDA

LONDON, March 6 /PRNewswire/ -- The biopharmaceutical company MediGene AG (NMarkt: MDG) announced today that its wholly owned subsidiary MediGene, Inc. based in San Diego, USA, has submitted a final study report of its phase 1 clinical trial for G207, a novel anticancer therapeutic for the treatment of brain tumors to the FDA, the US American Food and Drug Administration. The first results of the phase 1 study were published in the magazine Gene Therapy (2000 May; 7 (10):867-74). Prompted by the final analysis of the promising clinical data arising from the trial of brain cancer patients with advanced disease, MediGene is now preparing the phase 2 trial for G207.

"A phase 1 study is designed primarily to analyze tolerance and toxicity in patients to whom all known treatments have failed to bring any benefit, in this case brain cancer patients having received radiotherapy and chemotherapy beforehand. Positive results are extremely rare at this stage due to the progression of the disease. Brain cancer patients generally have a life expectancy of not more than six months after first diagnosis of the tumor - in this trial 10% of the patients treated with G207 are still alive more than two years after the end of treatment", stated Dr. Johanna Holldack, Chief Operating Officer of MediGene AG. "We are very excited about the outcome of the study. MediGene, Inc. is still following the surviving patients and so far has not found any evidence of long-term toxicity from this treatment."

It is estimated that 30,000 cases of malignant brain tumors are newly diagnosed in Europe and the USA alone per year. At present the treatment options are limited to surgery and radiation therapy which do not generally lead to lasting benefit for the patient. In the field of oncology a patient is considered to be cured after the tumor has disappeared and the patient has lived at least another five years after treatment.

G207 is a modified herpes simplex virus that has been genetically engineered to replicate in and kill cancer cells while sparing normal cells. Its unique properties allow it to be delivered directly into brain tumors without harm to surrounding healthy tissue. G207 also can be selectively and safely turned off by the common anti-herpes drug Acyclovir©. This combination of properties makes G207 ideally suited as a safe and selective anti-tumor therapeutic.

"We are extremely encouraged by the data on our novel selective therapeutic G207," said Frank Tufaro, Ph.D., Managing Director of MediGene, Inc. "It is clear that G207 can be delivered at relatively high doses without toxicity. We are now preparing to test G207 in a phase 2 trial in newly diagnosed patients, where we expect to have the most impact on disease outcome."

The phase 1 study of G207, which was designed to show the safety of the drug in humans, was recently completed in patients with recurrent, progressive malignant glioma at the University of Alabama, Birmingham, and Georgetown University Medical Center. Patients enrolled in a total of seven dose- escalating cohorts were inoculated with G207. No toxicity related to G207 was seen at any dose.

The phase 2 clinical studies MediGene is currently preparing are designed to show the efficacy of G207 both alone, and in combination with irradiation. Results from pre-clinical studies show a benefit from combining these two forms of therapy.

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of MediGene group as of the date of this release. These forward looking statements are no guarantees for future performance, and the forward- looking events discussed in this press release may not occur. MediGene group disclaims any intent or obligation to update any of these forward-looking statements.

Notes:

MediGene AG is a publicly quoted biopharmaceutical company with headquarters in Martinsried, Germany and a wholly owned subsidiary MediGene, Inc in San Diego, USA. The group combines a broad, proprietary technology portfolio, including the ITD, CVLP, AAV and HSV technology, with product candidates in pre-clinical and clinical development and has built up core competence in cardiac and cancer diseases, two areas of high medical need and huge market potential.

Five of MediGene's product candidates are currently in clinical trials: Polyphenon(TM)E to treat genital warts is in phase 3, the drug Etomoxir to treat congestive heart failure is in phase 2, G207 to treat brain cancers successfully completed phase 1 and is preparing for phase 2 trials, NV1020 to treat colorectal cancer metastatic to the liver is in phase 1 and a vaccine against cervical cancer is in phase 1/2 trials. For the development and the marketing of this vaccine as well as one additional tumor vaccine, strategic product alliances with Schering and Aventis Pharma have been concluded. However, the company also intends to market the majority of its product candidates on its own.

In the field of cardiology the unique technology platform "Integrated Target Definition" (ITD) combines methods of gene discovery, analysis and validation with the goal to find novel drug targets for specific cardiac diseases. Recently, MediGene AG signed two bioinformatics agreements with Gene Data AG and Compugen Inc. to enforce its ITD program. In addition MediGene AG employs Affymetrix' GeneChip® technology and Ciphergen's ProteinChip® technology.

SOURCE: MediGene AG

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