Melbourne, Australia; 10 November, 2010: Patrys Limited (ASX: PAB), which is focused on developing revolutionary treatments for cancer, announced today that it has completed the treatment of the first group of patients in a melanoma clinical trial for lead product PAT-SM6.
PAT-SM6 is a natural human antibody that has shown promise as a potential treatment for multiple types of cancer including melanoma; importantly, it is the first reported clinical product to target a protein on the surface of cancer cells called GRP78 that plays a number of key roles in cancer cell survival, growth and metastases.
The first group of three patients was screened at the Royal Adelaide Hospital (RAH) Cancer Centre and subsequently treated at the Pain and Anaesthesia Research Clinic, which is onsite at the RAH.
The first patient in this melanoma trial was treated on 19 October 2010, with the last patient in this group completing treatment on 1 November 2010. To date, no safety issues have been observed or reported for any patients treated with PAT-SM6.
Patrys has targeted a maximum of ten patients for this trial over ten months, so the Company is well within its anticipated timeline for completing the trial. Under the trial design, in total three different dose levels will be evaluated in three groups of patients.
Patrys Chief Medical Officer and President, Dr Marie Roskrow, commented: “We are very satisfied with the progress of this trial, both in terms of the product appearing safe to date, and the rate at which we are able to recruit patients.”
Melanoma is a very serious global medical problem, with an expected doubling of incidence every 15 years. Australia has the highest rate of skin cancer in the world, where nearly 10,000 cases are diagnosed each year. Current treatments for metastatic melanoma are largely ineffective, resulting in a five year survival rate of just 16%.
Patrys CEO, Dan Devine, added: “Advancing promising products through clinical development involves a number of important operational capabilities, including being able to produce quality material at large scale and recruiting patients for clinical trials in a timely fashion. Patrys has done both well with respect to the PAT-SM6 melanoma trial, which gives us great confidence going forward both for the development of PAT-SM6 and other Patrys lead products.”
The primary aim of the current melanoma trial is to evaluate the safety and tolerability of PAT-SM6. Multiple secondary endpoints are aimed at measuring the anti-tumour activity of PAT-SM6. All results will be finalised and reported at the end of the trial, which is expected to be by June 2011.
For further information, please contact:
Patrys Limited: Patrys Media and Investors: Daniel Devine Rebecca Wilson (IR) Erin Godfrey (Media) Chief Executive Officer Buchan Consulting P: +61 3 9670 3273 P: +61 3 9866 4722 info@patrys.com rwilson@bcg.com.au egodfrey@bcg.com.au
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibody therapies for cancer. Patrys has a deep pipeline of internal development candidates and additional products that are the subject of a collaboration agreement with a larger industry partner. More information can be found at www.patrys.com.
About PAT-SM6:
The natural human antibody PAT-SM6 has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. More specifically, Patrys has now screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type or patient age, gender or disease stage. With respect to melanoma, PAT-SM6 has shown particularly strong promise. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target, and the mechanism of action.
About GRP78:
Patrys clinical candidate PAT-SM6 binds to a form of Glucose-regulated protein 78 (GRP78), which is expressed on the surface of cancer cells but not detected on the surface of healthy cells. Once bound, the PAT-SM6/GRP78 complex is then internalised into cancer cells inducing apoptosis and cell death. The potential of GRP78 as a target for cancer therapy is supported by extensive third party literature that has reported several roles played by GRP78 with respect to promoting tumour proliferation, tumour survival, metastases and resistance to a wide variety of existing anti-cancer therapies. As a result, GRP78 expression has been correlated with an adverse prognosis in melanoma, breast, lung, gastric, hepatocellular and prostate cancer, and drug resistance in breast cancer. Given GRP78’s reported roles with respect to several cancers, a molecule such as PAT-SM6 presents a promising anti-cancer treatment to the extent it interferes with the function of GRP78 in cancer.
Appendix: PAT-SM6 Human Clinical Trial - Melanoma
Approval: Approval for this trial was granted by the Human Ethics Committee of the Royal Adelaide Hospital on 30 July 2010 and notification given to the Australian regulatory body, the Drug and Safety Evaluation Branch of the Therapeutic Goods Administration (TGA). The trial will be conducted under the TGA’s Clinical Trial Notification (CTN) scheme.
Global Standards: The trial will be conducted in accordance with the principles of the International Conference on Harmonization (ICH), which incorporate standards of conduct for clinical trials that are essentially uniform for all the major regulatory agencies world-wide, including the United States FDA and Australia’s TGA.
Trial Title: A Single Dose, Dose Escalating, Phase I Clinical Trial of PAT-SM6 Monoclonal Antibody in Patients with Recurrent In-Transit Cutaneous Melanoma
Primary Objectives: Establish the safety profile of a single dose of the anti-GRP78 monoclonal antibody PAT- SM6 in patients with recurrent in-transit cutaneous melanoma
Major Secondary Objectives:
Describe the pharmacokinetics of PAT-SM6
Screen for the development of patient antibodies against PAT-SM6 (immunogenicity)
Explore the anti-tumour activity of PAT-SM6
Assess the pharmacodynamic effect(s) of PAT-SM6 in patient tumour samples
Identify potential predictors (biomarkers) of therapeutic efficacy and/or safety
Method: This trial is a multicentre, open-label, dose-escalation, Phase I study. Patients will receive a single dose of PAT-SM6 intravenously, followed 96 hours later by collection of cutaneous tumour tissue.
