Onyvax-P May Significantly
Extend Progression Free Survival of Metastatic Prostate Cancer
London, UK -16 May 2005: Onyvax Limited, the biotechnology company
developing novel cancer therapies, today announced clinical data
from the second cohort of the Onyvax-P Phase II trial at the American
Society of Clinical Oncology meeting in Orlando, Florida. The
data show that treatment with Onyvax-P, the company's investigational
immunotherapy, may provide a significant clinical benefit to men
with metastatic hormone-resistant prostate cancer (HRPC). This
data strongly supports the findings of Cohort One which recruited
patients without bone metastases. As a result, pivotal Phase IIb/III
trials are planned to start in 2005.
The data showed that in 13 men who received treatment and whose
disease had metastasised to the bones the median progression free
survival (PFS) was 23 weeks, comparing favourably with the recently
published data of 9-17 weeks (Proc. AACR (2003) 44: abstract 5396;
Prostate (2004) 60:197-204). All 13 patients also received the
standard care - a continuation of hormone therapy plus supportive
care, when appropriate.
In addition to this PFS benefit, patients also showed prostate
specific antigen (PSA) responses to the treatment. 3 patients
(23%) experienced a prolonged, statistically significant reduction
in PSA velocity. PSA is a blood marker for prostate cancer and
at this stage of the disease generally increases exponentially
until death. A prolonged reduction in PSA velocity may predict
time to disease progression and survival in HRPC. Onyvax-P was
very well tolerated and side effects were limited to mild fatigue
and local injection-site reactions.
Commenting on these significant results, Dr Anthony Walker, CEO
of Onyvax, said, "The patients recruited to Cohort 2 had
more advanced disease than those in Cohort 1. We are delighted
that Onyvax-P shows activity in both metastatic and non-metastatic
HRPC. The complete data set strongly supports our decision to
move this product into randomised Phase II/III clinical studies.
Manufacturing of material for pivotal trials is underway and we
hope to start patient recruitment in 2005."
For further information, please contact:
Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494
Julia Philips / Lucy Briggs
+44 (0)20 7831 3113
Notes to Editors:
Trial Information: The trial recruited 48 patients
in two prospectively defined cohorts. The first cohort recruited
28 patients with HRPC with no bone metastases. The second cohort
recruited 20 patients with HRPC with bone metastases but no clinical
symptoms. Seven patients in Cohort Two did not receive treatment;
four showed progression during the four-week interval between
signing consent and receiving the first administration of Onyvax-P,
two failed an immunocompetence test and one was a protocol violator.
Data from Cohort One, which recruited men with non-metastatic
HRPC was released in June 2004 and showed a 100% increase in median
PFS compared to the literature and 40% patients showed statistically
significant PSA velocity responses. Survival data is still being
collected for both Cohorts.
The trial enrolled patients with all levels of Gleason scores
(a measure of the aggressiveness of prostate cancer) including
the highest risk patients. The mean Gleason score in Cohort Two
for whom data was available was 7.9.
Disease progression in the trial was defined by the development
of new lesions in the bone or soft tissue; the requirement of
palliative treatment with an opioid analgesic for new disease-related
pain; the occurrence of new disease-related symptoms that required
intervention such as treatment with chemotherapy, radiation or
surgery; the occurrence of a clinical event determined by the
investigator to represent disease progression, the investigator's
absolute judgement; or death.
Onyvax Ltd is a biotechnology company developing
novel cancer therapies that harness the selective power of the
immune system to seek and destroy tumour cells.
Founded in 1998, Onyvax has two product candidates in clinical
trials designed for the treatment of prostate and other cancers.
Onyvax's lead products are based on combinations of inactivated
cell lines that induce immune responses to a broad spectrum of
tumour targets. Onyvax-P, a Cell Vaccine for prostate cancer,
is due to enter pivotal Phase IIb/III clinical trials in 2005.
For each cancer type, Onyvax generates banks of proprietary cell
lines representative of different stages of the disease. The vaccines
are manufactured in bulk under standardised conditions.
Onyvax is committed to the commercialisation of new therapies
that significantly prolong survival while maintaining a high quality
of life for cancer patients. The Company is based in London and
has collaborations with leading institutions in Europe and the
Further information on Onyvax can be found at www.onyvax.com