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
Posted on: 03/06/2001
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Tuesday March 6, 7:03 am Eastern Time
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
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
"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
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
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©.
combination of properties makes G207 ideally suited as a safe and selective
"We are extremely encouraged by the data on our novel selective
therapeutic G207," said Frank Tufaro, Ph.D., Managing Director of MediGene,
"It is clear that G207 can be delivered at relatively high doses without
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
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
The forward-looking statements contained herein represent
the judgement of MediGene group as of the date of this release.
looking statements are no guarantees for future performance, and the forward-
looking events discussed in this press release may not occur.
disclaims any intent or obligation to update any of these forward-looking
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
Recently, MediGene AG signed two bioinformatics agreements with
Gene Data AG and Compugen Inc. to enforce its ITD program.
MediGene AG employs Affymetrix' GeneChip® technology and Ciphergen's
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