Ayala Pharmaceuticals Inc (ADXS)

[huskercatman123]

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Of the 50 patients evaluated, 19 survived at 12 months, and the overall 12-month survival rate for conversion to axalimogene filolisbac was 38%. In a recent 20 clinical trials conducted by the Gynecologic Oncology Group (GOG), this is the first trial of a 12-month survival rate for advanced cervical cancer greater than 30%, Ph.D., Public Health at the University of Alabama, Birmingham. Master's first treatment for advanced cervical cancer at 12 months, said Charles A. Leath III, MD, and Master of Public Health, Charles A. Leath III. The first author of the study was Warner Hugh, MD, of the University of Alabama. The study was conducted at twelve American cancer centers.
The researchers point out that the overall survival rate of these patients is more than 50% higher than the expected survival rate. "The highest 12-month survival of patients with severe, treated, recurrent cervical cancer to date," Dr. Leath said.
According to Dr. Leath, the results of this study are comparable to those of bevacizumab in gog-227c. The 12-month survival rate in this study was 30%, which directly led the drug regulatory authorities to use this drug as a first-line drug for combination chemotherapy. “This is very important because about half of the patients in the trial have previously received bevacizumab treatment.”
Axalimogene filolisbac contains an attenuated Listeria livelihood that is engineered to secrete HPV16 protein and fused with the hemolysin listeriolysin O truncation fragment. The conjugate target is HPV transformed cells, induces anti-tumor T cell immunity, and blocks the immune-tolerant tumor microenvironment.
Main findings
The finding comes from the Phase II GOG-0265 trial in patients with treated metastatic cervical cancer. More than half of the patients had previously received at least two treatments that exceeded the initial treatment intention. Three doses of axalimogene filolisbac were administered to patients who had only one treatment and were administered once a month.
At the primary endpoint of the play, the 12-month overall survival rate was 38%, exceeding the pre-set benchmark by more than 50%. In the subgroup carrying HPV16, the survival rate was 44%, and in the subgroup carrying HPV18, the survival rate was 41%.
The most common treatment-related adverse events (all grades) were fatigue (52%), cold (52%), anemia (48%), nausea (32%), and fever (30%). The most common grade 3 / 4 event was anemia, with an incidence of 10% in the patients assessed.
"Now we can see a broad prospect through clinical phase II trials, and we now have a treatment that has the potential to treat recurrent cervical cancer," commented Dr. Lia.
Axalimogene filolisbac has also been evaluated in two other HPV-related cancers: head and neck cancer and anal cancer. The US Food and Drug Administration has granted axolimogen filolisbac orphan drug status for these three clinical settings, as well as the Phase 3 clinical trial AIM2CERV Special Trial Program Evaluation (SPA) qualification, and opened a green channel for it.