The Motley Fool finance and investing website (Fool.com) reported on December 3rd, 2015 that Foamix Pharmaceuticals’ stock was up about 10% “after releasing positive results from its phase 2 clinical study of [their drug known as] FDX104.” The article headline exemplifies a certain insensitivity to patients when it comes to pharmaceuticals and money: “Foamix Pharmaceuticals Ltd Hopes to Profit from Eli Lilly’s and Amgen’s Side Effect.”
“FDX104 is designed to prevent moderate-to-severe skin rashes in patients treated with the epidermal growth factor receptor antibody inhibitors (EGFRI), such as Eli Lilly’s Erbitux and Amgen’s Vectibix,” said the article. “The rash, while not as life threatening as the cancer that Eli Lilly’s and Amgen’s drugs are designated to treat, can get so bad that doctors need to reduce the dose or even discontinue the treatment altogether,” added Fool.com.
The epidermal growth factor receptor is the cell-surface receptor for members of the epidermal growth factor family (EGF-family) of extracellular protein ligands.
The phase 2 study included a tiny portion of the patient population that’s using either Erbitux or Vectibix. While admitting that fact, Fool.com still sounded optimistic. “Foamix Pharmaceuticals trial enrolled just 24 patients, but the data look fairly strong. The patients acted as their own controls, putting FDX104 on one side of their face and placebo on the other. The drug side only had severe rash in four out of the 24 patients while the placebo side had a severe rash in nine of the 24. The difference was statistically significant,” it said.
“Foamix Pharmaceuticals needs to talk to the FDA to figure out how to proceed but will likely have to run a phase 3 program before getting FDX104 approved by regulators. Like all small phase 2 trials, the biggest risk is that the efficacy difference between FDX104 and placebo isn’t seen in a larger trial. The phase 2 data could be a fluke, but we won’t know until larger trials are run,” the website added.
Cetuximab is an EGFRI used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is distributed under the trade name Erbitux.
Fool.com did note that “There’s also the potential for side effects from FDX104 to be discovered when it’s tested in more patients, but the active ingredient, doxycycline, is a common antibiotic that’s sometime use as an oral off-label treatment for the rash, so it’s probably a low risk.” This, of course poses the ethical question of whether yet another drug would be developed to try to counteract any side effects from FDX104. (A drug to treat the side effect[s] of a drug that treats a side effect of a drug that treats the disease!)
“Investors in Eli Lilly and Amgen should keep an eye on the development of FDX104 because the companies will obviously benefit if FDX104 can help keep patients on their drug longer,” said the Motley Fool. As usual, patients and doctors could not be blamed for feeling unnerved by the great financial focus that is nearly always mixed into research, approval, and distribution of life-saving drugs.