Kintor to Colloborate with Applied Biology in COVID-19 Study of Proxalutamide
Kintor to Colloborate with Applied Biology in COVID-19 Study of Proxalutamide
(Summary description)Jiangsu, China, July 12, 2020 - Suzhou Kintor Pharmaceutical, Inc. a wholly-owned subsidiary of Kintor Pharmaceutical Limited (“Kintor Pharma”, 9939.HK), and Applied Biology, Inc. entered into a clinical trial research agreement ("Research Agreement"), pursuant to which Suzhou Kintor collaborates with Applied Biology to conduct research for Proxalutamide (GT0918) as a treatment for the novel coronavirus disease ("COVID-19"). We believe that this study is an innovative attempt to use anti-androgens as a possible treatment to devastating COVID-19 worldwide pandemic .
- Categories:Company news
- Time of issue:2020-07-14 18:26
Jiangsu, China, July 12, 2020 - Suzhou Kintor Pharmaceutical, Inc.* (蘇州開拓藥業股份有限公司), a wholly-owned subsidiary of Kintor Pharmaceutical Limited (“Kintor Pharma”, 9939.HK), and Applied Biology, Inc. ("Applied Biology") entered into a clinical trial research agreement ("Research Agreement"), pursuant to which Suzhou Kintor collaborates with Applied Biology to conduct research for Proxalutamide (GT0918) as a treatment for the novel coronavirus disease ("COVID-19"). We believe that this study is an innovative attempt to use anti-androgens as a possible treatment to devastating COVID-19 worldwide pandemic .
Professor Dr. Andy Goren (“Dr. Goren”) serves as the Chief Medical Officer of Applied Biology, which was established in 2002 in the United States, and is a biotechnology company specialising in the development and research of breakthrough drugs and devices for the treatment of of androgen and hair disorders. Dr. Goren’s publications have shown observations on a potential association between androgenetic alopecia and COVID-19 pathogenesis, which prompted Applied Biology to test anti-androgens as a treatment for male patients recently diagnosed with COVID-19. His clinical research has provided the scientific rationale for the early pharmacological interventions with therapeutic agents targeting androgen receptor pathway in COVID-19 patients.
The clinical trial (ClinicalTrials.gov identifier: NCT04446429) was registered by Applied Biology in accordance with the U.S. Food and Drug Administration Amendments Act of 2007 and the requirements of the International Committee of Medical Journal Editors in June 2020 (the "Existing Clinical Trial"). For the purpose of exploring the possible protective role of anti-androgens in COVID-19 infections, 254 male participants (“subjects”), who are aged 50 years old or above and present with androgenetic alopecia, are estimated to be enrolled in this study, which is double-blinded and placebo controlled. The experimental arm (50% of the participants) will be treated with Dutasteride + Standard Care (Ivermectin+ azithromycin) and the control arm (50% of the participants) will be treated with Placebo + Standard Care. Dutasteride is a medication used for benign prostatic hyperplasia and off-label for androgenetic alopecia in men. Ivermectin+ azithromycin are used as standard care given there has been no approved medication for coronavirus patients. The primary end point of the study is percentage of subjects hospitalized due to COVID-19 within 30 days.
Pursuant to the Research Agreement, Applied Biology will study Proxalutamide (GT0918) as an additional arm to the Existing Clinical Trial with around 120 male participants to be enrolled, and is expected to complete the proposed research study in six to nine months of the signing of the Research Agreement. Applied Biology will initially develop a research protocol for Proxalutamide (GT0918) which would be subject to independent ethic committee and institutional review board's approval. Dr. Goren, as the Principal Investigator, will supervise the research study and ensure its compliance with general standard of good clinical practice and all applicable laws and regulations. The findings of the research study are to be submitted for peer-reviewed and indexed publication.
Dr. Tong Youzhi, the Founder, Chairman and CEO of Kintor Pharma, said:” Coronavirus is continuing its spread across the world with more than 12 million confirmed cases in 188 countries. More than half a million people have lost their lives. While research institutes and pharmaceutical companies are actively pursuing therapies to prevent or treat coronavirus, it is critical to find a treatment that helps COVID-19 patients slow the progression. By doing so, the human immune system may have sufficient time to generate antibodies to fight against the novel coronavirus. We believe this research study demonstrates the possible therapeutic effect of Proxalutamide as an anti-androgen therapy to treat COVID-19. Moreover, it is a testament to our commitment to social responsibility as a biotech company.”
According to Dr. Goren, he said:”we are excited to partner with Kintor Pharma to study, what we believe is, the first novel molecule that reduces the expresions of both TMPRSS2 and ACE2, the two molecules implicated in SARS-CoV-2 infectivity. Provided our study demonstrates efficacy and safety, Proxalutamide could potentially be used as a first line treatment for COVID-19 male patients at the early stage of infection.”
Proxalutamide (GT0918) is Kintor's lead drug candidate and is in phase III clinical trials in China for metastatic castration-resistant prostate cancer (“mCRPC”) with a targeted submission of new drug application (“NDA filing”) in 2020. It is also undergoing phase II clinical trials for mCRPC in the United States. Proxalutamide (GT0918) is a potential best-in-class small molecule AR antagonist for the treatment of mCRPC based on well-researched AR mechanism and has a novel chemical structure that enables it to down regulate AR expression.
The Group's recent pre-clinical research collaboration with Soochow University in exploring the potential mechanism of COVID-19 gender disparity revealed that the blockage of AR signalling with AR antagonist Proxalutamide (GT0918) reduced the expression of ACE-2 and TMPRSS2 in normal lung cells and cancer cells derived from prostate and lung cancer. Proxalutamide (GT0918) also inhibited the expression of inducible nitric oxide synthase (iNOS) and tumour necrosis factor-alpha (TNF α), the macrophage-activation markers, in mouse macrophage cells. These results support the role of androgen-AR signalling in the disease progression and mortality in male patients with COVID-19 and were published on the SSRN on 23 April 2020. The collaboration with Applied Biology will further explore the therapeutic function of Proxalutamide (GT0918).
About Kintor Pharmaceutical Limited
Founded in 2009, Kintor Pharmaceuticals concentrates on the R&D and industrialisation of “best-in-class” and “first-in-class” innovative drugs, and strives to become a leading enterprise in the R&D and commercialization of innovative therapies. The Company, after years of development, centered upon androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. Kintor Pharmaceuticals has prospectively deployed a diversified product pipeline that includes small molecule innovative drugs, bioinnovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as AR-Degrader, c-Myc inhibitors and IDO inhibitors that are undergoing preclinical research. Globally, the Company owns more than 60 patents, many of which are listed as the “Major New Drugs Discovery” in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK.
About Applied Biology/Dr. Andy Goren
Applied Biology, headquartered in Irvine, California, is a biotechnology company specializing in hair science. It is committed to the development of breakthrough drugs and medical devices for the treatment of androgen and hair disorders. Dr. Andy Goren serves as the Chief Medical Officer of Applied Biology. Dr. Goren currently serves as a Medical Advisor and Co-Investigator, Department of Dermatology, The Warren Alpert Medical School, Brown University, a Medical Advisor and a Co-Researcher, Trichology Unit, Ramon y Cajal Hospital, Madrid, Spain, a Visiting Professor of Dermatology, Department of Dermatology and Venereology, Clinical Hospital Center Sestre Milosrdnice, Zagreb, Croatia, a Medical Doctor at the Skin & Cosmetic Research Dept., Shanghai Skin Disease Hospital, Shanghai, China, and a Visiting Medical Doctor, Department of Dermatology and Venereology, L.T.M. Medical College Sion, Mumbai, India. Dr. Goren has published dozens of peer-reviewed original medical research papers, and his latest research involves the use of anti-androgen therapy for the treatment of COVID-19.