London: Wednesday, 18 June 2014: Chi-Med today announces that Hutchison MediPharma Limited (“HMP”), the majority owned R&D company of Chi-Med, has initiated the first-in-human Phase I clinical trial of HMPL-523 in Australia. HMPL-523 is a novel, highly selective and potent small molecule inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. HMPL-523 is HMP’s second active immunology programme in clinical development. The first drug dose was administered on 17 June 2014.
As one of the major cellular components of the immune system, B-cells play pivotal roles in autoimmune diseases. Targeted B-cell receptor signalling therapy has been proven to be clinically effective for the treatment of rheumatoid arthritis (“RA”) and B-cell malignancies, leading to scientific and commercial success. Syk is an essential enzyme involved in B-cell receptor signalling pathway and a novel target for investigational therapies in immunology and oncology.
HMPL-523 is being developed as an oral formulation for the treatment of autoimmune diseases such as RA and lupus. In preclinical studies, HMPL-523 demonstrated superior potency and kinase selectivity, a reversal of the progression of joint inflammation and bone erosion along with a reduced production of multiple pro-inflammatory cytokines, as well as a favourable safety margin in both rodent and non-rodent toxicology studies.
The first-in-human trial aims to establish the safety profile of HMPL-523. This randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability and pharmacokinetics of single and repeat doses of HMPL-523 will be conducted in healthy volunteers. Initial results are expected around the end of this year.
“For these chronic inflammatory conditions, it is critically important to understand if the high Syk selectivity and very good pharmacokinetic properties of HMPL-523 in preclinical studies bear out into a good human safety profile,” said Christian Hogg, CEO of Chi-Med. “Should this be proven in this Phase I trial, this drug candidate will have potential as an effective oral treatment for patients with debilitating autoimmune diseases, for whom many existing treatments are limited or only modestly efficacious at safe doses,” he added.
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| Chi-Med Christian Hogg, CEO |
Telephone: +852 2121 8200 |
| Panmure Gordon (UK) Limited Richard Gray Andrew Potts |
Telephone: +44 20 7886 2500 |
| Citigate Dewe Rogerson Anthony Carlisle David Dible |
Telephone: +44 20 7638 9571 Mobile: +44 7973 611 888 Mobile: +44 7967 566 919 |
Rheumatoid arthritis (“RA”) is an autoimmune disease that affects many tissues and organs, but principally attacks flexible joints. Treatment of RA includes both painkillers and anti-inflammatory drugs, such as steroids, which relieve the symptoms but do not stop or slow down the disease progression. Disease-modifying anti-rheumatic drugs (DMARDs), including TNF-blocking biologics, are able to slow or halt the disease progression. The market for RA drugs is predicted to reach US$38.5 billion in 2017, according to Visiongain.
Lupus, or systemic lupus erythematous, is a systemic autoimmune disease that can affect any part of the body, particularly the heart, joints, skin, lungs, blood vessels, liver, kidney, and nervous system. Lupus can be fatal, and there is currently no cure for lupus. Patients with mild lupus are often prescribed with non-steroidal anti-inflammatory drugs (“NSAIDs”) while patients with more severe lupus may require corticosteroids or immunosuppressants.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising 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.
HMP is majority owned by Chi-Med. For more information, please visit: www.hmplglobal.com.
Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its China Healthcare Division manufactures, markets and distributes prescription and over-the-counter pharmaceuticals in China. Its Drug R&D Division focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its emerging Consumer Products Division focuses on organic and natural consumer products in Asia.
Chi-Med (LSE:HCM) is majority owned by the multinational conglomerate Hutchison Whampoa Limited (SEHK:13). For more information, please visit: www.chi-med.com.
London: Thursday, 5 June 2014: Chi-Med today announces that Hutchison MediPharma Limited (“HMP”), its majority owned R&D company, 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 4 June 2014.
This randomised, double-blind, placebo-controlled, multi-centre, 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 http://chi-med.com/eng/irinfo/presentations.htm. 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-centre 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 commercialisation agreement in China with Eli Lilly and Company for fruquintinib.
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Chi-Med Christian Hogg, CEO
|
Telephone: +852 2121 8200 |
|
Panmure Gordon (UK) Limited Richard Gray Andrew Potts |
Telephone: +44 20 7886 2500 |
|
Citigate Dewe Rogerson Anthony Carlisle David Dible |
Telephone: +44 20 7638 9571 Mobile: +44 7973 611 888 Mobile: +44 7967 566 919 |
At an advanced stage, tumours secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumour in order to provide greater blood flow, oxygen, and nutrients to the tumour. VEGF and VEGF receptors (“VEGFRs”) play a pivotal role in tumour-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 tumour to grow and invade. To date, several anti-VEGF/VEGFR agents have shown clinical efficacy against a number of tumour 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.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising 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.
HMP is majority owned by Chi-Med. For more information, please visit: www.hmplglobal.com.
Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its China Healthcare Division manufactures, markets and distributes prescription and over-the-counter pharmaceuticals in China. Its Drug R&D Division focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its emerging Consumer Products Division focuses on organic and natural consumer products in Asia.
Chi-Med (LSE:HCM) is majority owned by the multinational conglomerate Hutchison Whampoa Limited (SEHK:13). For more information, please visit: www.chi-med.com.