Onyvax PII cancer vaccine shows significant delay in disease progression
Onyvax, the biotechnology company developing novel cancer therapies, has published data that confirms results of the first cohort in a Phase II trial of Onyvax-P, the company's investigational immunotherapy, showing that it may delay progression in hormone resistant prostate cancer (HRPC) patients.
Onyvax, the biotechnology company developing novel cancer therapies, has published data that confirms results of the first cohort in a Phase II trial of Onyvax-P, the company's investigational immunotherapy, showing that it may delay progression in hormone resistant prostate cancer (HRPC) patients.
If the effects are repeated in forthcoming randomised trials, the safety and efficacy of this immunotherapy would make it a compelling treatment option for men at this stage of the disease.
Prostate cancer is the most common cancer in the United States. Local therapy (radiotherapy and/or surgery) is potentially curative, however a large number of men develop recurrent disease, which is treated with hormone therapy. A rising level of PSA (a blood marker for prostate cancer) during hormone therapy indicates the disease has developed resistance and it was patients at this stage who were recruited to the Onyvax clinical trial. According to the Atlas of Clinical Urology, HRPC patients develop asymptomatic bone metastases 26 weeks after a rising PSA, symptomatic bone metastases 17 weeks after that, followed by death 52 weeks later. The goal of this clinical trial was to delay the onset of metastatic disease.
The results showed that 42% of the treated patients showed statistically significant, prolonged decreases in their PSA velocity (PSAV) without experiencing significant toxicity and this is believed to be the first time this effect has been seen. Onyvax's vaccination approach resulted in an extended median time to disease progression (TTP) of 58 weeks, a large improvement to historical experience, which suggests a median TTP of 26-29 weeks.
Artificial Neural Network (ANN) analysis was used to show that certain cytokine profiles could predict clinical outcome with a high degree of accuracy. ANNs have previously not been used to associate complex immunological parameters with clinical responses. If the ANN data is validated then this methodology will prove useful in the future management of HRPC patients.
Onyvax plans to start Phase IIb/III pivotal clinical trials of Onyvax-P this year.