The studies conducted in collaboration with Reproductive Biology Associates, a US IVF clinic, show that eggs treated with Cumulase prior in vitro fertilization (IVF) using the intracytoplasmic sperm injection (ICSI) procedure were more likely to result in fertilization.
The experiment compared Cumulase to a currently used slaughterhouse-derived hyaluronidase extract in the preparation of human oocytes (eggs) prior to the ICSI procedure. The study revealed that Cumulase treated oocytes demonstrated significantly increased fertilization rates over oocytes exposed to the standard bovine-derived hyaluronidase extract.
The study involved 26 patients and 402 oocytes. The rate of fertilization following ICSI in eggs treated with Cumulase was 81.4% compared with 71.9% in eggs treated with the traditional bovine-derived extract, a 13% increase in fertilization rate. The range of average ICSI fertility rates in US fertility clinics is currently 70 to 75%
“These data are extremely encouraging,” said Dr Peter Nagy, scientific and laboratory director of reproductive biology associates in Atlanta. “In addition to the higher fertility rates, we found better embryo quality for transfer following treatment with Cumulase compared to the bovine-derived hyaluronidase extracts. Increased fertilization rates along with the better quality embryos for transfer are significant findings for the IVF community.”
Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase). Halozyme hopes the drug will replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of ICSI, in which the enzyme is an essential component. The enzyme removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more effective alternative to slaughterhouse-derived extracts.
According to Halozyme the total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the US.