• Patrys PAT-SM6 antibody detected in patient tumours
• Patrys product shows promise in multiple myeloma
• PAT-SM6 inhibits metastases in melanoma cancer model
• PAT-SC1 shows significant survival benefit in gastric cancer trial

Patrys PAT-SM6 antibody detected in patient tumours

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.

Patrys is currently undertaking a Phase 1 PAT-SM6 clinical trial in melanoma at the Royal Adelaide Hospital.  Under the trial design, in total three different dose levels will be evaluated in three groups of patients.

Patrys is now recruiting the third and final cohort of patients this trial.  The PAT-SM6 trial has been devoted to establishing safety and tolerability.  To date no safety issues have been observed or reported.  The primary objective of safety has been augmented by exciting outcomes in relation to specificity, with PAT-SM6 being detected in biopsies of two different patients who participated in the initial phases of the trial.  Analysis of the trial results is also suggestive that cancer cell death occurred in the samples collected.  These results are indicative of the potential of PAT-SM6 as an effective therapeutic for the treatment of melanoma.

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

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PAT-SM6 shows promise in multiple myeloma

In September 2011, Patrys announced the results of preclinical work conducted at The University Hospital of Würzburg showing the activity of PAT-SM6 in multiple myeloma.  Multiple myeloma is a type of bone marrow cancer arising from plasma cells, which are normally found in the bone marrow.  Plasma cells form part of the body’s immune system.

A major obstacle in the successful treatment of multiple myeloma is disease recurrence due in part to the outgrowth of chemotherapy- and novel agents-resistant plasma cells.

The study showed that Patrys’ product can specifically bind to multiple myeloma cells from both patients at the stage of primary diagnosis and also in relapsed individuals.  The product also mediates cell death in primary cells isolated from patients and typical cell lines used to study the disease in vitro.  This encouraging data provides sufficient proof of concept to warrant further study in multiple myeloma patients.

Of the approximately 1,200 Australians who are diagnosed with multiple myeloma each year, almost all are older than 40 years.  Multiple myeloma is most common in people aged 60 years and older, and men are affected more often than women.  In the United States, an estimated 20,520 adults will be diagnosed with multiple myeloma.  The five-year survival rate of people with multiple myeloma is about 39%.

PAT-SM6 inhibits metastases in melanoma cancer model

In August 2011, Patrys announced positive results from a new proof-of-concept study on its lead product PAT-SM6 in an animal model. The study examined PAT-SM6’s activity against metastatic melanoma.

PAT-SM6 was tested in the C8161 human metastatic melanoma tumour model in which the reduction of metastases was measured, mimicking the clinical situation.  The C8161 tumour model is a highly metastatic human melanoma cell line derived from a patient with advanced disease.  These cells typically metastasise aggressively after injection into athymic nude mice, a common animal model with low immunity.  The C8161 model is widely used to study the effect of chemotherapeutic drugs and biologics in vivo.

It was determined that treatment with Patrys’ antibody PAT-SM6 resulted in a highly statistically significant reduction of metastases in test animals.  Four different concentrations of PAT-SM6 were tested and all groups performed equally well when compared to control animals, resulting in a dramatic reduction of metastases.  Furthermore, PAT-SM6 proved to be as effective as the commercial standard of care drug dacarbazine.

This is the first time that PAT-SM6 has been tested in such an aggressive tumour model.  This positive data adds to an already existing preclinical database that supports the PAT-SM6 clinical program.  .”

PAT-SM6 is currently undergoing a Phase 1 clinical trial for melanoma at Royal Adelaide Hospital.  Patrys is concurrently extending its preclinical program to generate additional data and evidence to supplement the ongoing clinical program.

PAT-SC1 shows significant survival benefit in gastric cancer trial

In September 2011, Patrys announced positive results from a follow-up of gastric cancer patients who were treated with anti-cancer compound PAT-SC1.

PAT-SC1 was the first of the Patrys’ IgM antibodies to be used in a clinical trial.  Between 1997 and 2001, 51 patients with CD55-positive gastric cancer were treated with a single intravenous low dose of PAT-SC1 48 hours prior to surgery.  Of those 51 patients treated, 35 of them had no evidence of metastatic disease at operation and were classified as having R0 stage disease.  Patients did not receive any additional treatment (radiotherapy or chemotherapy).

Survival of these patients has been followed over time and compared to a historic control group of patients with R0 stage gastric cancer who did not receive PAT-SC1 before surgery.  Ten year follow-up data is now available on 30 of the PAT-SC1 treated patients.   Fifty-five per cent of these patients are still alive whilst only 30% of the control group have survived, indicating that the treatment of gastric cancer patients with PAT-SC1 confers a significant survival benefit.

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