The initial clinical protocol for Chemophase was designed to evaluate a single intravesical (into the bladder) administration of Chemophase along with the widely used anticancer drug mitomycin in patients with superficial bladder cancer.
The phase I study enrolled five patients with superficial bladder cancer, with its objectives being to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin.
According to data from the American Cancer Society, National Cancer Institute, American Urological Association, and Southwest Oncology Group Study, more than 100,000 patients have new or recurrent superficial bladder cancer in the US every year. All of these patients may be potential candidates for Chemophase in the event it is approved as first-line treatment with mitomycin.
A favorable FDA decision would also see Chemophase join Halozyme Therapeutics’ two currently approved products, Cumulase, the only recombinant human hyaluronidase for cumulus removal in the IVF process, and Hylenex, which is indicated for use as an adjuvant to increase the absorption and dispersion of other injected drugs.