The product, TFC-1067, will be tested at a concentration three times higher than what was used in a previous clinical trial, the drug company said in a statement. Higher dosing is expected to increase the effectiveness of the product as well as work more quickly than the previously established dose.
Vancouver-based Sirona’s shares have been on a tear over the past few months, rising over 640% to $0.52 from $0.08 since the start of the year. However, shares were were trading 11.9% lower Tuesday midday at C$0.52 on a broad market pullback.
Currently TFC-1067 is being tested in standard in vitro procedures, but Sirona’s consultant safety assessor CEHTRA has recommended further testing at the higher dose, the company said in a statement.
The higher doses will be assessed by cosmetic testing company Idea Lab. If results continue to show no evidence of skin irritation, Sirona will begin human clinical trials.
"The clinical effect of TFC-1067 to lessen dark spots or have an overall brightening effect is largely dose dependent,” said Sirona Biochem CEO Howard Verrico. "We anticipate TFC-1067 will be used at higher doses without adverse effects. While we are pleased with the excellent clinical results achieved so far, being able to test at significantly higher concentrations will likely lead to better clinical effectiveness, potentially faster results and a better range of consumer dosing options."
The new development is of “substantial commercial interest” to potential cosmetic partners in North America and China, the company said in a statement. According to data cited by Sirona, the global skin lightening market is expected to be valued at over US$30 billion within the next five years.
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