Halozyme reports positive results from Phase I/IIa cancer trial

Based on the results, the ChemoPhase combination treatment of mitomycin plus the recombinant human hyaluronidase (rHuPH20) enzyme was well-tolerated and appears safe, the company said. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme, and established the dose for subsequent clinical trials, therefore achieving the pre-defined primary objective of the study.

In addition, there were no neutralizing antibodies to rHuPH20 detected and the plasma concentration of mitomycin was either non-measureable or negligible and well below the threshold that may be predictive for myelosuppression, according to the company.

The study also provided support for future pivotal trial development that will incorporate the highest combination dose studied in the current trial, mitomycin plus 800,000 units of rHuPH20, said Halozyme.

As a result of this ongoing Phase I/IIa trial in determining the dose for subsequent trials and demonstrating the safety and tolerability of induction and maintenance dosing of ChemoPhase, Halozyme is making preparations to request meetings with the FDA and European regulators to discuss the optimal regulatory pathway to drug approval. Based on the outcome of these discussions, Halozyme plans to initiate its ChemoPhase pivotal clinical program in 2009.

Richard Yocum, vice president of clinical development and medical affairs at Halozyme, said: “We are pleased the study demonstrated that ChemoPhase was well-tolerated and produced no dose-limiting toxicities and we look forward to advancing the agent into pivotal studies.”