Specialised Therapeutics announces success of compassionate cancer program

A compassionate program run by Melbourne biotech Specialised Therapeutics (STA) has helped more than 240 Australian cancer patients to benefit from a world-leading new treatment based on nanoparticles, the company said.

STA is a distributor in Australia of Abraxane, which is a nanoparticle protein-bound chemotherapy agent, combining paclitaxel with albumin. Albumin is a naturally-occurring human protein designed to deliver paclitaxel without the need for solvents.

Developed using Abraxis BioScience's proprietary ‘nab’ technology platform, the drug facilitates the delivery of a 49 percent higher dose when compared to regular solvent-based paclitaxel, with no reported safety or tolerance issues.

In a recent randomised Phase III study of metastatic breast cancer patients, Abraxane demonstrated close to double the overall tumour response rate compared to solvent-based paclitaxel used on its own.

The drug is currently approved and reimbursed through Australia’s Pharmaceutical Benefits Scheme (PBS) for patients with metastatic breast cancer who have not responded to prior therapy. It is approved for the treatment of metastatic breast cancer in over 40 countries including Australia, the U.S, Canada, Japan, China and the EU, and over the last five years has been used to treat some 100,000 cancer patients.

However, it has shown to be effective in treating several other cancers including non-small cell lung cancer, metastatic pancreatic cancer and malignant melanoma. According to STA co-founder and CEO Carlo Montagner a total of 21 sites have so far begun enrolling patients for a Phase III pancreatic cancer trial with nine sites enrolling for a melanoma trial. He added that a recent Phase III non-small cell lung cancer trial in the US demonstrated very positive results, adding that he expected Abraxane to be approved in Australia and other markets for this indication within the next 12 months.

Montagner said that patients participating in STA’s compassionate program all suffer from one of these three cancers, and that all have responded positively to Abraxane, which Australian oncologists are given discretion to prescribe despite the fact that the drug is not yet formally approved for use beyond metastatic breast cancer. It has, however, been granted orphan drug designation by Australia’s Therapeutic Goods Administration TGA) for the treatment of pancreatic cancer.

Patients have each been given one month’s worth of Abraxane, which amounts to around $1 million at current market prices. The patients then pay to continue treatment at cost price until they reach $9000 after which ST subsidises treatment indefinitely.

STA specialises in treatments mainly targeting cancer and in addition to Abraxane, is also licensed to sell in Australia the drug ALOXI, which is a second generation 5-HT3 receptor antagonist used for the prevention of chemotherapy induced nausea and vomiting (CINV).

Montagner said that the company is currently seeking to raise between $50 and $60 million to fund development of its own early-stage compounds targeting the oncology market.