US cancer institute evaluating Peplin drug

By Pete Young
Friday, 31 May, 2002

The American National Cancer Institute is scheduling advanced appraisals of an Australian anti-cancer drug which has produced impressive results in preliminary trials.

Brisbane listed biomedical company Peplin Biotech said the NCI was sponsoring further study of its PEP005 anti-cancer compound after evaluating it against 60 human tumour types.

The NCI's Biological Evaluation Committee found ultra-low concentrations of PEP005 were active against a wide range of tumour cell lines, including colon, kidney and blood.

The in vitro screening program found the drug showed a novel spectrum of activity against the tumour cells lines compared with existing anti-cancer drugs, according to Dr Gordon Cragg, Chief of the Natural Products Branch of the NCI's Developmental Therapeutics Program and a member of the NCI's Biological Evaluation Committee.

"This is a very pleasant surprise, given our earlier work in Brisbane showed high potency against certain breast and prostate cancer cell lines, as well as melanomas", said Peplin Biotech's director of clinical and regulatory affairs, Dr Peter Welburn.

The results were achieved at pico molar concentration levels, or 20 micrograms in a 50,000 litre swimming pool, said Peplin managing director and chief executive Garry Redlich.

On the strength of its initial evaluation, the NCI is promoting Peplin's drug to the next stage of in vivo tests using mice.

The NCI, a $US4 billion taxpayer-funded organisation, will sponsor testing costs with Peplin retaining all IP rights to the product.

Should the drug meet in NCI's in vivo activity criteria, sponsorship of pre-clinical development of the drug in collaboration with Peplin will be considered, Cragg said.

Through its screening program, the NCI has participated in the development of more than half the anti-cancer drugs currently used in cancer chemotherapy.

Redlich said the NCI's data on PEP005's effects on colorectal cancer "may have an important positive up-side" for Peplin.

The company's other leading candidate for commercial development is a topical drug for skin cancer.

"We are particularly interested in finding other likely cancers to target with topical formulations of our drug," said Redlich. "Colorectal cancer just might be one of those."

Another Peplin drug is currently undergoing in vitro evaluation at the NCI with a third being readied for submission, he said.

From Peplin's viewpoint, the NCI's announcement was immaculately timed. The company, which raised about $8 million in its public listing more than two years ago, is in the final weeks of an 18-month process of negotiating licensing agreements with US specialty pharmaceutical companies for its non-melanoma skin cancer drug.

Skin cancers covered by Peplin's proprietary molecules include melanoma, Merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma and solar keratosis.

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