Heron Therapeutics Reaches Target Patient Enrollment in MAGIC Phase 3 Study of SUSTOL®
-Topline Results Expected in
-NDA Resubmission Expected Mid-Year 2015
This prospective, randomized, placebo-controlled, Phase 3 study compares
SUSTOL plus the neurokinin-1 (NK1) receptor antagonist
fosaprepitant and dexamethasone to the current standard of care for
delayed-onset CINV following administration of HEC agents, ondansetron
plus fosaprepitant and dexamethasone. The study has enrolled
approximately 900 patients receiving various HEC agents, as defined by
“This milestone marks an important step in the development of our lead
product candidate, SUSTOL, which has the potential to provide a safe and
effective treatment option for the many cancer patients suffering from
CINV,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of
About SUSTOL® and Chemotherapy Induced Nausea and Vomiting
Heron Therapeutics’ lead investigational product candidate, SUSTOL® (granisetron injection, extended release), is being developed for the prevention of both acute- and delayed-onset chemotherapy induced nausea and vomiting (CINV) following the administration of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) agents. Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. Injectable 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have been shown to be among the most effective and preferred treatments for CINV, however, an unmet medical need exists for patients suffering from CINV during the delayed-onset phase, which typically occurs one-to-five days following administration of chemotherapy agents. For delayed-onset CINV, only one injectable 5-HT3 receptor antagonist is approved for use following the administration of MEC agents, and none are approved for use following administration of HEC agents. SUSTOL contains the 5-HT3 receptor antagonist granisetron, selected due to its broad use by physicians based on a well-established record of safety and efficacy, and the fact that it is only currently approved for the prevention of CINV during the acute-onset phase. SUSTOL is formulated with the Company's proprietary Biochronomer® drug delivery technology and in clinical trials has been shown to maintain therapeutic drug levels of granisetron for up to five days with a single subcutaneous injection.
About HTX-019 for Chemotherapy Induced Nausea and Vomiting
HTX-019 is a proprietary injectable formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. At present, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions or other adverse reactions in some patients. Heron Therapeutics’ formulation for HTX-019 does not contain polysorbate 80, and may have a lower incidence of infusion-site reactions than reported with the other commercially available injectable NK1 receptor antagonist.
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. The effective management of pain with a reduction in the use of opioids remains an important area of unmet medical need, and HTX-011 could potentially provide a differentiated therapeutic profile with advantages compared to currently available pain management options. In a Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam. Therapeutically relevant plasma bupivacaine levels were sustained for 2-3 days in the absence of the large initial peak that can be observed with commercially available formulations. The anesthetic effects of HTX-011 persisted through 96 hours, which closely correlated with plasma bupivacaine concentrations, and HTX-011 was well-tolerated with no serious adverse events. Heron plans to move HTX-011 into Phase 2 clinical development in the second quarter of 2015.
About HTX-003 for Chronic Pain and Addiction
HTX-003, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of buprenorphine for the management of chronic pain and opioid addiction. HTX-003 is designed to maintain therapeutic drug levels of buprenorphine for 30 days following a single subcutaneous injection with a low potential for patient abuse.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
Barry D. Quart, 650-366-2626
Pharm.D., Chief Executive Officer