Final Patient in Cohort Demonstrates Tumour Marker Reduction
Released
Released
Announcement PDF
24th March 2015
ASX Release
FINAL PATIENT IN LOWEST DOSE COHORT
DEMONSTRATES REDUCTION IN KEY TUMOUR MARKER
TREATMENT WITH PPL-1 DEMONSTRATES REDUCTION IN KEY TUMOUR
MARKER p70S6K
PharmAust Limited (“PharmAust”) (ASX: PAA & PAAO) is pleased to report that the third and final patient in the
lowest dose cohort for the trial at the Royal Adelaide Hospital has been assessed for reduction in the blood
marker, p70S6K, following treatment with PPL-1. The patient, suffering from lung cancer with metastases to the
liver, brain and bone received PPL-1 for 28 days and demonstrated approximately a 50% reduction of p70S6K
levels at both days 3 and 7 of treatment.
Aberrant expression of p70S6K is believed to contribute to aggressive features of cancer such as growth, invasion
and metastasis. p70S6K levels in peripheral blood immune cells are expected to correlate with similar changes
in the patient's cancer. Studies in peer review journals have shown that factors that increase Mammalian Target
of Rapamycin (mTOR)/ p70S6K signalling, lead to increased metastasis in human breast cancer cells. Similarly,
activation of p70S6K has been shown to increase viability of colorectal cancer cells. Published evidence also
suggests that some globally used anticancer drugs (Paclitaxel) may operate through inactivation of p70S6K.
Professor David Morris of the St George Hospital, Sydney said, “We have consistently observed that PPL-1
inhibits the p70S6K blood marker in patients with different cancers (6 out of 6 patients). The degree of inhibition
has varied between 10% and 65% as compared to the levels of p70S6K in patient’s blood before treatment with
the drug (Day 1, pre-treatment). Although only three patients completed the 28-day treatment regimen, we have
managed to determine the levels of p70S6K in a total of 6 patients who have received the drug for 3 days or more.
Thus, despite the delays in completing the treatment of the first cohort due to patient withdrawals (unrelated to
drug), we have managed to obtain p70S6K data from a larger group of patients giving higher statistical significance
to the result (p<0.0005 at day 3).
Professor Michael Brown, Principal Investigator of the study at the Royal Adelaide Hospital said, “The use of
surrogate tumour markers in the diagnosis of cancer and assessment of progression is now ubiquitous in clinical
oncology. Although many cancers have a specific “marker association”, p70S6K appears to be a common
indicator of malignancy. Typically, information on drug efficacy is hard to observe in phase I safety studies,
particularly at the lowest doses being tested. The results so far indicate that PPL-1 is well tolerated at the lowest
dose and it appears to be physiologically active in that it reduces a key indicator associated with malignancy."
The cancer chemotherapy market (estimated at $42 billion/annum)* is currently the fastest growing sector within
the pharma industry, mainly driven by the identification of new potential therapeutic targets. This growth is further
fuelled by the magnitude of the disease worldwide, currently estimated at more than 25 million people suffering
from cancer globally, and an estimated 5 million people dying each year from the disease.
*Reference: Research and Markets.com accessed 14th February 2014:
http://www.researchandmarkets.com/reports/335548/chemotherapy_market_insights_20062016_a
For further details please contact:
Dr Roger Aston
Executive Chairman
PharmAust Limited
Tel: 0402 762 204
www.pharmaust.com
PharmAust Limited ABN 35 094 006 023. Suite 7, 29 The Avenue, Nedlands, Western Australia
Tel: 08 9386 8767 Fax: 08 9389 1464
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