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Antineoplastons A10 and AS2-1 Show Promise in Recurrent Brain Cancer: Presented at ICACT
By Jill Stein
PARIS, FRANCE -- February 1, 2006 -- Antineoplastons A10 and AS2-1 (ANP) are showing favorable results for the treatment of recurrent, diffuse intrinsic brain stem glioma, according to results reported here at the 17th International Congress on Anti-Cancer Treatment (ICACT).
The data also show that ANP -- consisting of antineoplaston A10 (A10-I) and antineoplaston AS2-1 injections -- is well tolerated, according to lead researcher Stanislaw Burzynski, MD, Director, Burzynski Clinic, Houston, Texas, United States.
Dr. Burzynski presented findings on 48 patients who participated in phase 2 trials of ANP. All patients in the analysis had failed prior treatments.
"Patients with recurrent, diffuse intrinsic brain stem gliomas are not candidates for radiation therapy and do not respond to cytotoxic chemotherapy including temozolomide," he pointed out in his presentation on February 1st. "Thus, new treatments are clearly needed."
Patients received daily injections of ANP through a subclavian venous catheter and a double channel infusion pump.
The median duration of ANP administration was 5 months. The average dose of A10-I was 8.39 g/kg/day, and the average dosage of AS2-1 it was 0.33 g/kg/day.
Responses were assessed by gadolinium-enhanced magnetic resonance imaging scans repeated every 8 weeks and confirmed by positron emission tomography if necessary. The primary endpoint was overall survival measured from the time of diagnosis.
Results show an overall survival rate of 35.4% at 2 years and 20.8% at 5 years.
Seventeen percent of patients had a complete response, 17% had a partial response, 41% had stable disease, and 25% had progressive disease.
Median survival time was 15.2 months, and maximum survival was 18+ years
Anemia was documented in 6% of patients, granulocytopenia in 2% and hypertension in 2%. Serious adverse drug reactions were sporadic and reversible, and there were no chronic toxicities, Dr. Burzynski said.
"The data demonstrate a significant percentage of complete and partial responses and long-term survival in a group of patients with recurrent, diffuse intrinsic brain stem glioma," he said. "The complete and partial response rates are significantly higher and the survival substantially longer for patients treated with ANP compared to patients treated in phase 2 studies of temozolomide."
The mechanism of action of A10-I and AS2-1 involves methylation of DNA and acetylation of histones, which leads to activation of silenced tumor suppression, Dr. Burzynski explained. A10-I normalizes global hypomethylation of the genes which decreases the DNA instability and amplification of oncogenes.
He added that phase 3 trials with ANP in children with brain stem glioma are scheduled to start this year.
[Presentation title: Phase II Studies of Antineoplastons A10 and AS2-1 (ANP) in Patients with Recurrent, Diffuse Intrinsic Brain Stem Gliomas.]