Peplin drug tests safe on the surface

Brisbane cancer-drug developer Peplin Biotech (ASX:PEP) is preparing to run a phase II trial of its promising skin-cancer drug PEP005 early next year, after completing a multi-centre, Phase I safety trial in US volunteers with actinic keratoses.

Commonly known as solar keratoses, actinic keratoses are patches of dry, flaking skin that can give rise to squamous-cell carcinoma (SCC), one of the most common forms of skin cancer.

All patients completeted the trial, which involved a single application of a PEP005 topical gel to the skin, with no report of any serious, adverse effects.

Peplin's MD and CEO, Dr Michael Aldridge, said that although the company is still awaiting a full analysis of the double-blind, placebo controlled trial, it is encouraged by early indications that the drug is safe and well tolerated.

Peplin is confident enough to begin planning a Phase II trial to test PEP005's efficacy as a treatment for actinic keratoses and basal cell carcinoma (BCC).

Peplin has promising indications from animal models that PEP005 may have broad, non-selectivity activity against common skin cancers like BCC and SCC, as well as melanoma, the deadliest form of skin cancer.

In addition to its cytotoxic and pro-inflammatory activity, PEP005 also appears to stimulate the proliferation of healthy skin cells, including fibroblasts and keratinocytes.

PEP005's appeal as a potentially non-invasive, non-scarring alternative surgical excision of cancers, might also extend beyond the therapeutic market, according to Aldridge.

He said Peplin "has a shot" not only at the potentially lucrative market for non-surgical treatment of skin cancers, but at the thriving cosmetic dermatology market.

A 'live fast, die pretty' generation of wealthy Western consumers have embraced Botox injections, Retin A creams and collagen implants. Peplin is well aware that PEP005 could find a potentially lucrative, non-therapeutic market if clinical trials confirm its skin-rejuvenating properties.

Peplin recently took back PEP005 from its US collaborator, Allergan, the US company that has made a fortune from Botox. Under an agreement signed in November 2002, Allergan paid Peplin $1.8 million for the right to develop the drug as a treatment for SCC and BCC. Allergan was also interested in PEP005 as a potential treatment for psoriasis.

Aldrige confirmed that several large and medium-sized pharmaceutical companies have expressed interest in partnering Peplin to develop PEP005 as a non-surgical treatment for non-melanoma skin cancers.