Big week for Australian biotechs

Queensland biotech Progen Pharmaceuticals has commenced a Phase III study of its liver cancer drug PI-88, involving 600 patients in over 65 hospitals throughout the world.

PI-88 is a multi-targeted cytostatic cancer drug and inhibits both angiogenesis and metastasis. It has received Orphan Drug designation from the European Medicines Evaluation Agency (EMEA) and fast-track designation from the FDA for post-resection liver cancer.

Progen's Phase III trial, called Pathway (Pi-88 in the adjuvant treatment of HCC), involves the use of the drug as an adjuvant treatment for primary liver cancer following surgical intervention.

Melbourne's Avexa has begun planning Phase III trials following the successful completion of a Phase IIb clinical trial of its lead anti-HIV drug apricitabine (ATC).

ATC is a nucleoside reverse transcriptase inhibitor, which inhibits the activity of the enzyme that HIV needs to reproduce and is intended for use in patients who have developed viral resistance to existing drugs.

Avexa's Phase IIb trial, held in three segments, achieved good results with no clinical resistance to ATC detected. Avexa said levels of CD4 cells in the patients' blood showed a marked increase, indicating that the drug was having a beneficial effect on their immune systems.

Avexa has also announced an agreement with US company Monogram Biosciences to use its portfolio of phenotypic resistance assays to test Avexa's drug candidates.

Melbourne-based ChemGenex has launched a phase II study of its lead candidate, omacetaxine mepesuccinate, for refractory acute myeloid leukaemia (AML).

The study, to be held in two hospitals in France, will enroll up to 27 patients with the aim of achieving complete and partial remission.

Omacetaxine, formerly known by the trademark Ceflatonin, is believed to affect a number of cellular pathways, including the regulation of genes associated with apoptosis and angiogenesis. The compound is currently in Phase II trials for chronic myeloid leukaemia.

Melbourne's Clinuvel Pharmaceuticals has received Orphan Drug status from the EMEA for its photo-protective drug CUV1647 in two indications.

CUV1647 is an analogue of alpha-melanocyte stimulating hormone and acts by stimulating the levels of eumelanin in the skin. It is aimed at five different photo-sensitive indications, including sun poisoning, sun intolerance, pre-cancerous skin lesions and photo-sensitivity associated with cancer treatment.

Orphan drug status has been awarded for erythropoietic porphyria (EPP), a rare genetic disease in which sufferers have severe light-sensitivity. Exposure to the sun causes intolerable pain, swelling and scarring.

The other is the extremely rare congenital erythropoietic porphyria (CEP), also known as Gunther's disease, in which phototoxic damage and infection can lead to mutilations of facial features and fingers. Clinuvel is currently treating one CEP patient on compassionate grounds.

South Australian biotech Bionomics has begun a safety and tolerability evaluation program of its anti-anxiety candidate, BNC210, in animals.

Bionomics, which is progressing well with its lead anti-cancer drug BNC105, is planning a pre-Investigational New Drug (IND) application with the US FDA later this year.

BNC105 is a vascular targeting agent that disrupts tumour blood vessels. It began Phase 1 trials last week.

The safety studies for Bionomics' anxiolytic compound will be carried out in the US. In a statement, Bionomics said preclinical data showed that BCN210 was able to reduce anxiety very quickly in animals without common side-effects such as drowsiness and memory and motor function impairment.

In NSW, applications for the BioFirst Commercialisation Awards will close on April 28.

The award is presented to a NSW biotechnology or medical device company that demonstrates the best case for achieving international success with a technology, product or service that has been developed with assistance through the NSW BioBusiness programs.

Winners receive a cash prize toward international business development activities from Merck Sharpe and Dohme; expert advisory services on tax and business structuring from PricewaterhouseCoopers; expert advisory services on intellectual property protection and commercialisation from Allens Arthur Robinson; expert advisory services on capital markets issues from eG Capital; expert advisory services on technology commercialisation and/or business development from Invetech; and expert advisory services in media and public relations from Buchan.

The winner will be announced in June. Applications are available from The NSW Department of State and Regional Development.