Allergan files INDs for Peplin's topical treatment

Peplin Biotech (ASX: PEP) today announced the filing of three separate Investigational New Drug (IND) applications with the US Food and Drug Administration for a topical formulation of its lead compound PEP005.

In pre-clinical studies, PEP005 has shown promise for the treatment of the pre-cancerous condition actinic keratosis -- sometimes known as “sun-spots” -- and two non-melanoma skin cancers; basal cell carcinoma and squamous cell carcinoma. The INDs are for the treatment of these three conditions.

If accepted, the IND will allow PEP005 to be tested in human trials in the US.

The filings were made by US dermatology-specialist Allergan – who will sponsor the INDs. Allergan last year licensed PEP005 from Peplin for the topical and intralesional treatment of skin and eye conditions in North and South America. Allergan will be responsible for the clinical development of the product in the US.

The IND filing will trigger a payment of US$1 million to Peplin under the licence agreement.

Peplin’s Managing Director and CEO, Michael Aldridge said that the filings were the most significant event in the company’s history.

"If we don't have a clinical halt put on the product in 30-60 days then we are free to initiate clinical trials," he said.

“The enormous quantum of pre-clinical studies and data which have been assembled for the INDs represent a hugely valuable base which Peplin can rapidly leverage into other applications for PEP005 in other forms of cancer, including those treated by systemic and intra-lesional forms of therapy.”

PEP005 was developed from research by former CSIRO biochemist Dr James Aylward, and is an extract of Euphorbia peplus, commonly known as milkweed.

According to Allergan, actinic keratosis affects approximately 50% of caucasians who are older than 40 years of age.

Basal cell carcinoma and squamous cell carcinoma affect an estimated 1.85 million people in the USA. Non-melanoma skin cancer is the most common of all forms of cancer and is the fastest growing with incidence increasing at 6-7% per annum.