Boston, MA 10/07/2014 (wallstreetpr) – Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) disclosed that it has started Phase II study with FDX104, its contemporary formulation of doxycycline. This is to put a stop to the rash in cancer patients preferring epidermal growth factor receptor inhibitors of EGFRI.
Severe Acne-Like Rashes
According to a statement issued to the media, patients of 45% and 100%, who are taking drugs for EGFRI like Vectribix and Erbitux, were affected by rigorous acne-like rashes. Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) pointed out that the trial was the second stage multicenter, double-blind, randomized, vehicle-controlled clinical trial. This is meant to investigate the tolerability, safety and efficacy of FDX104 administered specifically for the prevention of EGFRI associated skin toxicity in 24 patients with cancer.
Foamix indicated that there was a preliminary period of screening, i.e. five weeks of treatment. After this, a post-treatment would be followed up after four weeks. Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) pointed out that it would take about seven days following the study drug initiation and randomization; patients would commence their EGFRI treatment.
Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) stated that the principal aim was to illustrate the tolerability and safety of FDX104 adjunct to any one of Vectibix or Erbitux treatment. It said that tolerability and safety would be investigated by measurements of key signs, severity of adverse events, incidence and skin tolerability evaluation. The company disclosed that the study was taking place in Israel.
Management Comments
Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) CEO, Dov Tamarkin, said that skin rash was the most commonly witnessed side effects in patients taking treatment with EGFRI. As a result, it had the possibility of patients changing their dosages of the drugs for anti-cancer or even discontinuing the treatment fully. He said that its FDX104 trial was meant to take care of such patients with topical foam of convenience. At the same time, it would avoid the risk of the systemic side effects apart from any possible drug-drug interactions of oral antibiotics.
