- Published: 03 June 2015
- Written by Editor
New cancer therapy study results - MAGIC Trial
EAST SETAUKET, N.Y., June 1, 2015 -- NSHOA Cancer Center and Heron Therapeutics, Inc. (HRTX) today announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company's 5-HT3 receptor antagonist product candidate SUSTOL® (granisetron injection, extended release) as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents.
NSHOA Cancer Center had a major impact in the MAGIC study. Jeffrey Vacirca, M.D., was chosen to be Principal Investigator for the study for the entire country and NSHOA Cancer Center was one of the top enrollers in the United States. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types.
The study's primary endpoint was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL group than the comparator group.
"The substantial benefit observed with SUSTOL in Complete Response, nausea and overall satisfaction with therapy is all the more impressive given the comparator was a three-drug, standard-of-care regimen. Also, unlike previous CINV studies, all patients in the MAGIC trial came from U.S.-based community oncology centers, so the results are highly representative of what we would expect to see in our patients," stated Jeffrey Vacirca, M.D., Principal Investigator, NSHOA Cancer Center.
Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics stated, "We look forward to presenting additional data from the MAGIC study at an appropriate upcoming scientific conference, but our immediate focus is now the resubmission of our New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), which we expect in mid-2015. In addition, we are planning for the commercial launch of SUSTOL, pending FDA approval."
NSHOA Cancer Center would like to thank all the patients who volunteered to participate in this very important study.
CONTACT: Nicole Gregory, 1-631-525-1823
