Initiation of fruquintinib Phase II study in NSCLC

Shanghai: Thursday, June 5, 2014: HMP today announces that it has initiated a Phase II clinical trial in non-small cell lung cancer (“NSCLC”) patients in China for fruquintinib (HMPL-013), its investigational small molecule agent that is designed to selectively inhibit vascular endothelial growth factor receptors (“VEGFR”).  Preparations and patient screening began earlier this year, with the first patient dosed on June 3, 2014.

This randomized, double-blind, placebo-controlled, multi-center, proof-of-concept (“POC”) Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy.  This trial is to evaluate the efficacy and safety of fruquintinib versus placebo in NSCLC patients.  All patients will receive best supportive care.  The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety.  Approximately 90 patients will be enrolled, with top-line results expected in 2015.

Fruquintinib is designed to selectively inhibit VEGF receptors, including VEGFR1, 2, and 3.  In the first-in-human Phase I clinical trial, 40 late-stage cancer patients were treated with fruquintinib.  Detailed results of the Phase I clinical trial were presented at the annual meeting of the American Association for Cancer Research in April 2013, and are available at www.hmplglobal.com/en/publications.  Based on the Phase I data, the first POC Phase II study was initiated on 2 April 2014, which was a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial targeted at treating patients with locally advanced or metastatic colorectal cancer.

In October 2013, HMP entered into a licensing, co-development and commercialization agreement in China with Eli Lilly and Company for fruquintinib.

About vascular endothelial growth factor (“VEGF”) and non-small cell lung cancer (“NSCLC”) in China

At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to the tumor.  VEGF and VEGF receptors (“VEGFRs”) play a pivotal role in tumor-related angiogenesis, and thus inhibition of the VEGF/VEGFR pathway represents an exciting therapeutic strategy in blocking the development of new blood vessels essential for tumor to grow and invade.  To date, several anti-VEGF/VEGFR agents have shown clinical efficacy against a number of tumor types including colorectal, liver, breast and gastric cancer, amongst others.

Lung cancer is the most common cancer both worldwide and in China.  The American Cancer Society estimated that about 220,000 new cases of lung cancer were diagnosed in the United States each year.  In China, lung cancer is the most commonly diagnosed cancer, with over 715,000 cases in 2012, accounting for 18.7% incidence among all cancer patients.  It is also the most common cause of cancer death.  There are two major types of lung cancer: small cell lung cancer and NSCLC.  NSCLC is a disease in which malignant cancer cells form in the tissues of the lung, and can be further classified based on cancer cell types with the most common ones including squamous cell carcinoma, large cell carcinoma and adenocarcinoma.

About HMP

HMP is a novel drug R&D company focusing on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases.  With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.  For more information, please visit: www.hmplglobal.com.