Starton Therapeutics Phase 2 TROPIC-I Clinical Study will be First to Use Total Control Primary Endpoint in Superiority Study

STAR-OLZ for acute and delayed chemotherapy induced nausea and vomiting (CINV)

PARAMUS, N.J., June 16, 2021 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company transforming standard of care therapies with proprietary transdermal technology, announces Type C Meeting Responses from the US Food and Drug Administration (FDA) leading to the finalization of the Company’s clinical development approach for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). STAR-OLZ is a multi-day transdermal (TDS) delivery system of olanzapine, which has been shown to be a powerful antiemetic, but is not currently approved for nausea or vomiting indications.

CINV is among the most debilitating and feared side-effects of cancer treatment. Current guidelines recommend a three or four drug regimen to prevent CINV for the million people receiving highly emetogenic chemotherapy (HEC) each year in the US (American Cancer Society 2021); however, 60 to 70 percent still struggle with nausea (Chow 2021).

“STAR-OLZ represents the first product to be developed for FDA approval using the Total Control primary endpoint, which we believe will generate more clinically meaningful data for evaluating CINV treatment than prior trials for currently approved therapies,” said Jamie Oliver, Chief Medical Officer. “Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications.”

The largest and most comprehensive meta-analysis of the use of olanzapine in CINV was published a few months ago (Chow 2021). A total of 13 studies were included in the HEC-treated analysis. In the delayed interval (24-120 hours after chemotherapy), 58 percent of people treated with olanzapine (553/952) reported No Nausea versus 38 percent (300/793) in the control group (p=0.0004). Similarly, during the acute phase (0-24 hours), 73 percent of people treated with olanzapine reported No Nausea versus 57 percent treated with the standard of care (p=0.003). Despite significantly more people reporting No Nausea with olanzapine, CR was similar between olanzapine and non-olanzapine regimens in acute, delayed and overall intervals, reinforcing the limitations of this endpoint in evaluating CINV treatments.

The Type C meeting was requested as an extension of a positive pre-IND meeting held with the FDA in July 2020 to gain further agreement from the FDA on the Company’s clinical approach for the development of STAR-OLZ in CINV. The meeting provided guidance for the design of the planned Phase 2 clinical study and endpoint strategy, as well as planned work to support the validation of a nausea scale. Starton is on target to submit its Investigational New Drug (IND) application for STAR-OLZ in Q3 2021 and expects to launch its Phase 2 clinical trial shortly thereafter in Q4 2021.

About STAR-OLZ

Olanzapine has been shown to be a powerful antiemetic but is not approved for any nausea or vomiting indications. STAR-OLZ, a multi-day TDS delivery system of olanzapine has been evaluated using a disease-model challenge study to confirm the efficacious blood levels of the drug in nausea and vomiting and a healthy human volunteer study assessed the pharmacokinetics of TDS. STAR-OLZ is in development for two nausea and vomiting indications: CINV and PARP-inhibitor induced nausea and vomiting (PIINV).

The clinical development program is scheduled to advance in late 2021 with the launch of Study TROPIC-I, a Phase 2 dose-optimization study in HEC comparing the superiority of STAR-OLZ to an NK1-regimen for CINV in approximately 60 people. The study is expected to enroll at an estimated 20 clinical sites in the US. The study will assess STAR-OLZ superiority in Total Control (defined as no nausea, no vomiting, and no rescue medications) and no difference in the control of vomiting compared to the current treatment with combinations containing a 5-HT3, dexamethasone and NK1 antagonist.

Starton licensed the rights to develop and commercialize STAR-OLZ in Mainland China to Haisco Pharmaceutical Group. The Company intends to retain the rights in the United States and is exploring partnerships in the rest of the world.

About Starton Therapeutics

A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary transdermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. To learn more, visit www.startontx.com.

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