Halozyme trial shows Cumulase improves IVF fertilization rate by 22% compared to bovine extract

By Lisa Kerner

Erie, Pa., May 4 - Halozyme Therapeutics, Inc. said its prospective, randomized, blinded, sibling oocyte clinical trial showed a per-patient rate of in vitro fertilization (IVF) following intracytoplasmic sperm injection (ICSI) in mature eggs treated with Cumulase was 85.3%, compared to 70% for eggs treated with the traditional bovine-derived extract product Hyase.

In addition to the 22% increase in fertilization rate, the data showed a trend toward higher quality embryos with Cumulase (43% of excellent quality) compared to Hyase (25%).

The enzyme Cumulase, an ex vivo formulation of rHuPH20, removes the hyaluronic acid that surrounds the oocyte for injection of the sperm, according to a company news release.

The study, involving 26 patients and 402 oocytes, was published in the May issue of Fertility & Sterility in a paper entitled "Comparison of bovine- and recombinant human-derived hyaluronidase with regard to fertilization rates and embryo morphology in a sibling oocyte model: a prospective, blinded, randomized study."

"These data are extremely encouraging," article author Z. Peter Nagy of Reproductive Biology Associates in Atlanta said in the release.

"Cumulase has not only helped us standardize a key step in the process, but also paid dividends in increasing our ICSI fertilization rates. We now routinely achieve an over 85% ICSI fertility rate using Cumulase, compared to the national average of 70% to 75%"

Halozyme said a subsequent, similar trial is underway to evaluate longer term clinical outcomes.

The total cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005.

Halozyme received CE Mark approval of Cumulase in December 2004 and Food and Drug Administration 510(k) clearance in April 2005.

Halozyme, a San Diego biopharmaceutical company, develops recombinant human enzymes for the drug delivery, palliative care, oncology and infertility markets.

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