Replies to post #4974 on Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Correct.

Detailed Description:
Phase 2, multicenter open-label randomized study with two run-in phases. The first run-in phase was to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. A second run-in phase was to evaluate a new formulation of PEGPH20. Phase 2 will be an open-label randomized study with same study drugs evaluating safety and efficacy.
Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all inclusion/exclusion criteria.
Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel + Gemcitabine given once/week 2-4 hrs after PEGPH20 and nab-paclitaxel + gemcitabine alone
Safety parameters include medical history, physical exams, adverse event and Concomitant med collection, Doppler and CT scans for thromboembolic events, prophylactic enoxaparin, Karnofsky Performance scale, Immunogenicity, Hematology, Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters include standard of care CT scans, CA19-9, tumor analysis of HA.
Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.

Here is the Clinicaltrials.gov link:
https://clinicaltrials.gov/ct2/show/NCT01839487?term=halo-109-202&rank=1