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What: Shares in Halozyme Therapeutics (NASDAQ:HALO) jumped by 10% at one point earlier today after the company presented positive interim trial results for PEGPH20, a therapy for the treatment of metastatic pancreatic cancer, at the ASCO conference in Chicago over the weekend.
So What: Pancreatic cancer is notoriously tough-to-treat, and advances that could offer patients new treatment alternatives typically garner a fair amount of investor attention.
In Halozyme Therapeutics' phase 2 trial for PEGPH20, interim results show that progression free survival rates in patients taking PEGPH20 alongside Abraxane and gemcitabine were double the rates of those taking Abraxane and gemcitabine alone.
Additionally, patients in the PEGPH20 arm of the trial also had a higher overall response rate of 52%, versus 24% for the control arm.
Those results are based on patients with a high expression of hyaluronan, a chain of natural sugars that can collect around cancer cells and reduce the effectiveness of cancer drugs like Abraxane and gemcitabine.
Now What: The efficacy results are encouraging, but it may be the safety results that are most important.
Halozyme Therapeutics' trial had been halted temporarily over safety worries for patients at risk of thromboembolism, or TE, and the halt resulted in Halozyme Therapeutics changing its trial to exclude patients most at risk of TE. The interim safety data presented at ASCO seem to indicate that the new trial parameters, including the addition of an anticoagulant to the treatment regimen, are reducing TE events. Overall, none of the 20 people receiving PEGPH20 and 1mg/kg/day of an anticoagulant had a TE event, compared to 18% of 17 patients in the control arm.
The results suggest that Halozyme Therapeutics remains on track to launch its phase 3 study early next year; however, investors should recognize that Halozyme Therapeutics is far from a risk-free investment. The results from this mid stage trial include a small number of patients and the data is interim, so a lot could change between now and the eventual release of phase 3 data.
Having said that, Halozyme Therapeutics' financial picture appears to be brightening as royalties pick up following the approval of Baxter's Hyqvia, which uses Halozyme Therapeutics' technology to help reduce the number of infusions required by immunodeficiency patients. In large part thanks to FDA approval of Hyqvia last fall, Halozyme reported sales of $18.7 million in the first quarter, up from $12 million last year, and a net loss of $0.12 per share, down from a net loss of $0.22 a year ago. Regardless, since the company isn't expected by analysts to turn a profit anytime soon, investors should approach Halozyme Therapeutics cautiously.