Take two: Peplin's revised IND filed

Brisbane-based Peplin Biotech (ASX: PEP) announced today that its US partner Allergan had filed two amended IND applications with the FDA for Peplin's PEP005, a topical formulation for skin cancer treatment.

Allergan originally filed INDs in March for Phase I clinical trials of the drug in three indications -- the pre-cancerous condition actinic keratosis, basal cell carcinoma and squamous cell carcinoma -- but following discussions with the FDA, the company withdrew its initial INDs and revised the applications to provide a more comprehensive Phase I/II evaluation of the drug.

"The clinical protocols have been redefined," said Peplin CEO Michael Aldridge. "There will be an initial Phase I safety study, moving toward a more comprehensive dose response evaluation in the Phase II study. The FDA wanted to understand more about how the drug works."

The new INDs will focus initially on actinic keratosis and basal cell carcinoma -- the two most prevalent indications -- and the companies are likely to wait for results from these studies before evaluating the drug's use in treatment of squamous cell carcinoma.

"The information which we expect to secure in these initial studies will be most efficiently obtained by focusing on the more common AK and BCC," said Aldridge. "Following successful completion of the initial Phase I safety studies Allergan plans to initiate dose response safety and efficacy Phase II studies for the AK, BCC and SCC indications."

Aldridge said that Peplin had supported the shift by Allergan to focus on the two more common indications.

While Allergan is responsible for the trials, Peplin will be providing the formulated PEP005 for the trials, said Aldridge. The compound, which is a single molecule entity, is extracted from a plant source and purified prior to formulation as a topical treatment.

In the meantime, Peplin will continue to pursue the development of additional applications for PEP005 as a treatment for other kinds of cancer including bladder cancer and leukaemia.