HONG KONG, Apr 23, 2020 – (ACN Newswire) – CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) of the precision therapy avapritinib for two indications, one for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations; the other for the treatment of adults with unresectable or metastatic fourth-line GIST. Developed by CStone's partner Blueprint Medicines, avapritinib is an investigational, orally available, potent and selective inhibitor of KIT and PDGFRA mutant kinases. This is the first time CStone has submitted an NDA to the NMPA and marks another milestone in the Company's transition toward commercialization.
— The China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for two indications for avapritinib, a first-in-class precision therapy, in gastrointestinal stromal tumor (GIST), marking a key milestone in CStone's transition toward commercialization
— In just three months after avapritinib was approved by the U.S. FDA, CStone has submitted NDAs for avapritinib in Taiwan and mainland China, with the goal of soon making this new drug accessible in Greater China
— Results from the NAVIGATOR study have shown an overall response rate (ORR) of 86% in patients with PDGFRA exon 18 mutant GIST and an ORR of 22% in fourth-line GIST
— Preliminary results from the bridging study conducted by CStone in China demonstrate safety and pharmacokinetic profiles consistent with those previously reported for the global NAVIGATOR study
With an annual incidence rate of 1-1.5 per 100,000, there are approximately 14,000 to 21,000 new cases of GIST in China every year1, and around 90% of these cases are associated with dysregulated cell growth due to mutations in KIT or PDGFRA tyrosine kinases. In January 2020, avapritinib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, and became the first precision medicine approved for the treatment of GIST harboring a PDGFRA exon 18 mutation in the United States.
"In just three months after avapritinib was approved by the U.S. FDA, CStone has submitted NDAs for this drug candidate in Taiwan and mainland China, which we hope will soon make this first-in-class precision therapy candidate accessible to patients with advanced GIST in Greater China," said Dr. Frank Jiang, Chairman and CEO of CStone. "As CStone continues to accelerate its transition toward commercialization, we plan to submit several NDAs in China across multiple indications for our lead assets in the next few months."
"Avapritinib has demonstrated outstanding antitumor activity and a well-tolerated safety profile in advanced PDGFRA exon 18 mutant GIST and fourth-line GIST. Due to the very limited benefits from approved treatment options in these two groups of GIST patients, there is an urgent unmet clinical need for new therapies," said Lin Shen, M.D., Professor and Director of Department of Gastrointestinal Oncology, Vice President of Peking University Cancer Hospital and Institute, and the principal investigator for the bridging study of avapritinib in GIST in China. "As a physician, I hope avapritinib will soon be available in our clinical practice for the treatment of advanced GIST."
Results from the Phase I NAVIGATOR study of avapritinib in PDGFRA exon 18 mutant GIST and fourth-line GIST were presented at the Connective Tissue Oncology Society Annual Meeting in November 2019. As of the data cutoff date of November 16, 2018:
– 43 patients with PDGFRA exon 18 mutant GIST and 111 patients with fourth-line GIST were treated at a starting dose of 300 or 400 mg once daily and evaluable for response assessments.
– In patients with PDGFRA Exon 18 mutant GIST, the overall response rate (ORR) was 86% with one response pending confirmation, and the median duration of response (DOR) was not reached.
– In patients with fourth-line GIST, the ORR was 22% with one response pending confirmation, and the median DOR was 10.2 months.
The Phase I/II bridging study conducted by CStone in patients with advanced GIST in China has produced encouraging preliminary results demonstrating avapritinib was well-tolerated, and safety and pharmacokinetic profiles were consistent with those previously reported for the global NAVIGATOR study.
"The current treatment approach for GIST in China is mainly based on sequential tyrosine kinase inhibitors (TKIs), but the approved TKIs only offer limited efficacy2 in patients with PDGFRA D842V mutations. Moreover, Chinese patients with fourth-line GIST face challenges on multiple fronts, including drug-resistant mutations and a lack of effective treatment options," said Dr. Jason Yang, Chief Medical Officer of CStone. "I am pleased that the bridging study in China has yielded results consistent with those from the global NAVIGATOR study, and I hope patients with advanced GIST who are in urgent need for new treatment options will benefit from this precision therapy in the near future."
CStone Pharmaceuticals and Blueprint Medicines have an exclusive collaboration and license agreement for the development and commercialization of avapritinib and certain other drug candidates in mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for these licensed products in the rest of the world.
About Avapritinib
Avapritinib is an investigational, selective and potent inhibitor of KIT and PDGFRA mutant kinases. It is a type 1 inhibitor that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. Avapritinib has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies in Greater China.
Blueprint Medicines is pursuing a broad clinical development program for avapritinib across multiple lines of GIST treatment, as well as for advanced, smoldering and indolent systemic mastocytosis.
Avapritinib is a kinase inhibitor approved by the U.S. FDA under the brand name AYVAKIT for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Avapritinib is not approved for the treatment of any other indication in the U.S. or for the treatment of any indication by the TFDA in Taiwan, by the NMPA in mainland China or by any other health authority in any other jurisdiction.
About CStone
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, 5 late-stage candidates are at pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com
Forward-looking Statement
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.
References
1. Yanbing Zhou. The current status in the diagnosis and treatment of gastrointestinal stromal tumor. Chinese Journal of General Surgery, 2017,032(007):549-552.
2. Cassier PA, Fumagalli E, Rutkowski P, Schoffski P, Van Glabbeke M, Debiec-Rychter M, et al. Outcome of patients with platelet-derived growth factor receptor alpha-mutated gastrointestinal stromal tumors in the tyrosine kinase inhibitor era. Clin Cancer Res. 2012;18(16):4458-64.
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Tag: HealthCare
TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin) Meets Primary Endpoint in Phase III Clinical Trial
HONG KONG, Apr 22, 2020 – (ACN Newswire) – TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK) is pleased to announce that the randomized Phase III clinical trial of TAB008 (Pusintin) has recently reached the predefined primary endpoint. The Company will continue to push forward the new drug application (NDA) of TAB008 (Pusintin) as scheduled.
Ms. Yeh Huang, Chun Ying, General Manager of TOT BIOPHARM, said, "We are very excited about the Phase III Clinical Trial of TAB008 (Pusintin) reaching the predefined primary endpoint. There are many combination therapies and other opportunities for expansion of indications which can be explored by TAB008 (Pusintin) in the future, which could fulfill the needs of an enormous number of patients. After the commercialization of TAB008 (Pusintin), it is expected to create more profits for us. In the future, we will continue to develop new anti-tumor drug products with high technological barriers and economic value, providing an appropriate and affordable product portfolio."
About TAB008 (Pusintin)
TAB008 is an anti-vascular endothelial growth factor monoclonal antibody (anti-VEGF mAb), a biosimilar drug candidate for bevacizumab. Bevacizumab was approved for launch by the U.S. Food and Drug Administration as early as 2004, under the product name of Avastin. It has obtained recognition for treatment of seven indications, including metastatic colorectal cancer, NSCLC, malignant glioma, renal cell carcinoma, ovarian carcinoma, breast cancer and cervical cancer. According to a report by Frost & Sullivan, China's market size for bevacizumab biosimilars will reach approximately RMB14.2 billion in 2024 through enormous market demand.
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Path-Away(R), Active Ingredient in Plant-Based, Alcohol-Free NatShield(TM) Hand Sanitiser Developed by Holista CollTech, Tested >99.99% Effective Against COVID-19 Surrogate
KUALA LUMPUR / PERTH, Apr 22, 2020 – (ACN Newswire) – Path-Away(R), a plant-based natural active ingredient used in the alcohol-free NatShield(TM) hand sanitiser developed by Malaysia-based and Australia-listed Holista CollTech (ASX: HCT), has been tested by a leading U.K. bio-safety laboratory to be more than 99.99% effective against a surrogate of the COVID-19 novel coronavirus, Holista said today.
Holista announced that the positive results of the test by an internationally recognised laboratory is a major step in its efforts to help prevent the spread of the pandemic that so far has infected more than 2.4 million people and killed over 625,000 people worldwide.
Path-Away(R) is developed by Global Infections Control Consultants LLC ("GICC LLC"), headquartered in South Carolina, United States. Holista is the global distributor of Path-Away(R) under the trademark NatShield(TM) hand sanitiser containing 3% of Path-Away(R).
While Path-Away(R) had already been proven previously to be effective as a broad-spectrum sanitiser capable of killing a range of viruses, bacteria and fungi without the use of alcohol or toxic chemicals, both GICC LLC and Holista decided to subject it to tests by a recognised bio-safety laboratory using protocols that are accepted internationally.
Path-Away(R) works by attaching itself to the virus and weakening its walls. It inhibits its ability to take up amino acids – their basic building block. This forces the viruses to clump together, in the process of killing themselves, almost instantly. The compound is environmentally safe with very low toxicity and does not harm humans and pets.
The latest U.K. test results confirm that Path-Away(R) in Natshield(TM) has an efficacy of at 4.17Log (99.99% efficacy) within a minute against the feline coronavirus (a surrogate of COVID-19) when tested at a concentration of 3%. This means that 99.99% of the virus is killed within a minute of exposure to Natshield(TM) – a huge attribute to an all-natural sanitizer that is free of alcohol and chemicals.
The feline coronavirus is increasingly used in international testing as a surrogate to COVID-19 as there are huge bio-security and safety concerns for laboratories handling the actual virus. In line with regulations of Australia's Therapeutic Goods Administration, claims of efficacy against COVID-19 as a disinfectant must be made with surrogate human or animal coronaviruses including the feline coronavirus. The U.K. laboratory tested Path-Away(R) against the feline coronavirus (Realm: Riboviria; Order: Nidovirales; Family: Coronaviridae; Genus: Betacoronavirus; Species: COVID-19).
The deadly novel coronavirus has been given the official name of Severe Acute Respiratory Syndrome Coronavirus 2 ("SARS-CoV-2") by the International Committee for Taxonomy of Viruses, while the World Health Organisation has named the disease caused by the virus as Coronavirus disease 2019 ("COVID-19").
COVID-19's ability to survive on surfaces for up to nine days while remaining aerosolised, or airborne, is among the reasons attributed for its rapid global spread in recent weeks. In view of rising infections and fatalities due to the pandemic, GICC LLC and Holista expedited the tests to facilitate specific claims against COVID-19 for Natshield(TM).
"Path-Away(R) was subjected to high international standards of testing against COVID-19 and we are elated by the results. We hope these results will advance the global efforts to combat the spread of this coronavirus, future contagions and even the common flu by something very natural and environmentally friendly," said Dr Arthur V. Martin, President of GICC LLC.
"This is highly significant for NatShield(TM). The results have satisfied the European standard that applies to areas and situations where disinfection is medically indicated. This scientific validation means that NatShield(TM) can be used to sanitise the hands without the need for rinsing, can be applied to the face and even inside the nose without irritation and is not harmful even if swallowed. It may also be sprayed safely to sanitise a person's immediate surrounding space, without any negative effects," said Dr Rajen Manicka, CEO of Holista.
Holista and GICC LLC have issued instructions to commence further tests on Path-Away(R) to assess its efficacy against COVID-19 via the more rigorous direct inoculation method. This additional testing is being conducted at biosafety laboratory approved by the U.S. Centers for Disease Control ("CDC"). Results will be released once the testing procedure is completed based on the current work schedule.
Path-Away(R)'s ingredients are Generally Regarded As Safe ("GRAS") certified, approved by the Food and Drug Administration ("FDA") and exempted by the Environmental Protection Agency ("EPA") – all under the U.S. FIFRA 25(b) Code of Federal Regulations. It is listed in the U.S. Pharmacopeia ("USP") and has undergone successful USP-51 testing. Path-Away(R) is also approved by the American Food and Safety Authority and Environmental Protection Authority of New Zealand.
About Holista CollTech Ltd
Holista CollTech Ltd ("Holista") is a natural wellness company, the result of a merger between Holista Biotech Sdn Bhd and CollTech Australia Ltd. The company has 3 main divisions:
– Dietary supplements and personal care
– Food Ingredients
– Ovine collagen
Holista has a global collaboration for Path-Away(R), a plant-based solution that is proven to kill a broad spectrum of microbes. The all-natural alcohol-free solution is an active ingredient in Holista's proprietary hand sanitiser, NatShield(TM) that is sold under its personal care range.
Holista researches, develops, manufactures and markets "health-style" products to address the unmet and evolving needs of natural medicine. Holista's suite of ingredients includes low-GI baked products, reduced-sodium salts, low-fat fried foods and low-calorie sugar without compromising taste, odour and mouthfeel. Holista remains the only company to produce sheep (ovine) collagen using patented extraction methods. For more information, please refer to http://www.holistaco.com
Further Information About the U.K. Testing
The testing at the U.K. laboratory had commenced 12 March 2020 based on all accepted testing protocols needed to provide data for Holista and GICC LLC to make label claims specific to COVID-19, which was formerly referred to as "2019 novel coronavirus" or "2019-nCoV".
The testing panel also included other members of the coronavirus family such as SARS and the more common human influenza virus. The testing was completed in April 2020.
The test in the U.K. laboratory used the standard method BS EN 14476. This describes a test method and the minimum requirements for virucidal activity of a chemical disinfectant and antiseptic products. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European standard applies to areas and situations where disinfection is medically indicated
– in patient care (for example: In hospitals, in community medical facilities)
– in dental institutions or in clinics of schools, of kindergartens and of nursing homes
– in the workplace and in the home
– may also include services such as laundries and kitchens supplying products directly for patients
Outline of Test Method (Obligatory Test Conditions)
A sample of the test product is added to a test suspension of viruses in a solution of interfering substance. The mixture is maintained at one of the temperatures and contact times specified in the standard. At the end of this contact time, a portion is taken. The virucidal action in this portion is immediately suppressed by a validated method. The dilutions are transferred into cell culture units either using monolayer or cell suspension. Infectivity tests are done either by plaque test or quantal tests.
After incubation, the titres of infectivity are calculated according to Spearman and Kaber or by plaque counting. Reduction of virus infectivity is calculated from differences of lg virus titres before (virus control) and after treatment with the product. The standard minimum spectrum of test organisms is Poliovirus, Adenovirus and Murine Norovirus.
The test used the standard method BS EN 14476. This describes a test method and the minimum requirements for virucidal activity of a chemical disinfectant and antiseptic products. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European standard applies to areas and situations where disinfection is medically indicated
– in patient care (for example: In hospitals, in community medical facilities)
– in dental institutions or in clinics of schools, of kindergartens and of nursing homes
– in the workplace and in the home
– may also include services such as laundries and kitchens supplying products directly for patients
Acceptance Criteria
The product when tested as above shall demonstrate at least a 4 log10 reduction against the test virus. The test is deemed valid where all control requirements are met.
Test Result
The test product received has achieved a >4-log reduction when tested under the condition stipulated in this report, against Feline coronavirus (surrogate of SARS-CoV2) when tested at a concentration of neat(3%).
4 Log Reduction
Scientists use a logarithmic scale to see the growth of virus. Log reduction stands for a 10-fold (or one decimal point) reduction in virus, meaning the disinfectant reduces the number of live viruses by 90 percent for every step of the division. A 4-log kill reduces the colony or viruses by a 99.99% reduction.
Media Contact:
holista@wer1.net (+65 67374844)
karishma@wer1.net (+65 84792656)
Corporate Affairs & Business Opportunities
Dr Rajen Manicka: rajen.m@holistaco.com
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Path-Away(R), Active Ingredient in Plant-Based, Alcohol-Free NatShield(TM) Hand Sanitiser Developed by Holista CollTech, Tested >99.99% Effective Against COVID-19 Surrogate
KUALA LUMPUR / PERTH, Apr 21, 2020 – (ACN Newswire) – Path-Away(R), a plant-based natural active ingredient used in the alcohol-free NatShield(TM) hand sanitiser developed by Malaysia-based and Australia-listed Holista CollTech (ASX: HCT), has been tested by a leading U.K. bio-safety laboratory to be more than 99.99% effective against a surrogate of the COVID-19 novel coronavirus, Holista said today.
Holista announced that the positive results of the test by an internationally recognised laboratory is a major step in its efforts to help prevent the spread of the pandemic that so far has infected more than 2.4 million people and killed over 625,000 people worldwide.
Path-Away(R) is developed by Global Infections Control Consultants LLC ("GICC LLC"), headquartered in South Carolina, United States. Holista is the global distributor of Path-Away(R) under the trademark NatShield(TM) hand sanitiser containing 3% of Path-Away(R).
While Path-Away(R) had already been proven previously to be effective as a broad-spectrum sanitiser capable of killing a range of viruses, bacteria and fungi without the use of alcohol or toxic chemicals, both GICC LLC and Holista decided to subject it to tests by a recognised bio-safety laboratory using protocols that are accepted internationally.
Path-Away(R) works by attaching itself to the virus and weakening its walls. It inhibits its ability to take up amino acids – their basic building block. This forces the viruses to clump together, in the process of killing themselves, almost instantly. The compound is environmentally safe with very low toxicity and does not harm humans and pets.
The latest U.K. test results confirm that Path-Away(R) in Natshield(TM) has an efficacy of at 4.17Log (99.99% efficacy) within a minute against the feline coronavirus (a surrogate of COVID-19) when tested at a concentration of 3%. This means that 99.99% of the virus is killed within a minute of exposure to Natshield(TM) – a huge attribute to an all-natural sanitizer that is free of alcohol and chemicals.
The feline coronavirus is increasingly used in international testing as a surrogate to COVID-19 as there are huge bio-security and safety concerns for laboratories handling the actual virus. In line with regulations of Australia's Therapeutic Goods Administration, claims of efficacy against COVID-19 as a disinfectant must be made with surrogate human or animal coronaviruses including the feline coronavirus. The U.K. laboratory tested Path-Away(R) against the feline coronavirus (Realm: Riboviria; Order: Nidovirales; Family: Coronaviridae; Genus: Betacoronavirus; Species: COVID-19).
The deadly novel coronavirus has been given the official name of Severe Acute Respiratory Syndrome Coronavirus 2 ("SARS-CoV-2") by the International Committee for Taxonomy of Viruses, while the World Health Organisation has named the disease caused by the virus as Coronavirus disease 2019 ("COVID-19").
COVID-19's ability to survive on surfaces for up to nine days while remaining aerosolised, or airborne, is among the reasons attributed for its rapid global spread in recent weeks. In view of rising infections and fatalities due to the pandemic, GICC LLC and Holista expedited the tests to facilitate specific claims against COVID-19 for Natshield(TM).
"Path-Away(R) was subjected to high international standards of testing against COVID-19 and we are elated by the results. We hope these results will advance the global efforts to combat the spread of this coronavirus, future contagions and even the common flu by something very natural and environmentally friendly," said Dr Arthur V. Martin, President of GICC LLC.
"This is highly significant for NatShield(TM). The results have satisfied the European standard that applies to areas and situations where disinfection is medically indicated. This scientific validation means that NatShield(TM) can be used to sanitise the hands without the need for rinsing, can be applied to the face and even inside the nose without irritation and is not harmful even if swallowed. It may also be sprayed safely to sanitise a person's immediate surrounding space, without any negative effects," said Dr Rajen Manicka, CEO of Holista.
Holista and GICC LLC have issued instructions to commence further tests on Path-Away(R) to assess its efficacy against COVID-19 via the more rigorous direct inoculation method. This additional testing is being conducted at biosafety laboratory approved by the U.S. Centers for Disease Control ("CDC"). Results will be released once the testing procedure is completed based on the current work schedule.
Path-Away(R)'s ingredients are Generally Regarded As Safe ("GRAS") certified, approved by the Food and Drug Administration ("FDA") and exempted by the Environmental Protection Agency ("EPA") – all under the U.S. FIFRA 25(b) Code of Federal Regulations. It is listed in the U.S. Pharmacopeia ("USP") and has undergone successful USP-51 testing. Path-Away(R) is also approved by the American Food and Safety Authority and Environmental Protection Authority of New Zealand.
About Holista CollTech Ltd
Holista CollTech Ltd ("Holista") is a natural wellness company, the result of a merger between Holista Biotech Sdn Bhd and CollTech Australia Ltd. The company has 3 main divisions:
– Dietary supplements and personal care
– Food Ingredients
– Ovine collagen
Holista has a global collaboration for Path-Away(R), a plant-based solution that is proven to kill a broad spectrum of microbes. The all-natural alcohol-free solution is an active ingredient in Holista's proprietary hand sanitiser, NatShield(TM) that is sold under its personal care range.
Holista researches, develops, manufactures and markets "health-style" products to address the unmet and evolving needs of natural medicine. Holista's suite of ingredients includes low-GI baked products, reduced-sodium salts, low-fat fried foods and low-calorie sugar without compromising taste, odour and mouthfeel. Holista remains the only company to produce sheep (ovine) collagen using patented extraction methods. For more information, please refer to http://www.holistaco.com
Further Information About the U.K. Testing
The testing at the U.K. laboratory had commenced 12 March 2020 based on all accepted testing protocols needed to provide data for Holista and GICC LLC to make label claims specific to COVID-19, which was formerly referred to as "2019 novel coronavirus" or "2019-nCoV".
The testing panel also included other members of the coronavirus family such as SARS and the more common human influenza virus. The testing was completed in April 2020.
The test in the U.K. laboratory used the standard method BS EN 14476. This describes a test method and the minimum requirements for virucidal activity of a chemical disinfectant and antiseptic products. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European standard applies to areas and situations where disinfection is medically indicated
– in patient care (for example: In hospitals, in community medical facilities)
– in dental institutions or in clinics of schools, of kindergartens and of nursing homes
– in the workplace and in the home
– may also include services such as laundries and kitchens supplying products directly for patients
Outline of Test Method (Obligatory Test Conditions)
A sample of the test product is added to a test suspension of viruses in a solution of interfering substance. The mixture is maintained at one of the temperatures and contact times specified in the standard. At the end of this contact time, a portion is taken. The virucidal action in this portion is immediately suppressed by a validated method. The dilutions are transferred into cell culture units either using monolayer or cell suspension. Infectivity tests are done either by plaque test or quantal tests.
After incubation, the titres of infectivity are calculated according to Spearman and Kaber or by plaque counting. Reduction of virus infectivity is calculated from differences of lg virus titres before (virus control) and after treatment with the product. The standard minimum spectrum of test organisms is Poliovirus, Adenovirus and Murine Norovirus.
The test used the standard method BS EN 14476. This describes a test method and the minimum requirements for virucidal activity of a chemical disinfectant and antiseptic products. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European standard applies to areas and situations where disinfection is medically indicated
– in patient care (for example: In hospitals, in community medical facilities)
– in dental institutions or in clinics of schools, of kindergartens and of nursing homes
– in the workplace and in the home
– may also include services such as laundries and kitchens supplying products directly for patients
Acceptance Criteria
The product when tested as above shall demonstrate at least a 4 log10 reduction against the test virus. The test is deemed valid where all control requirements are met.
Test Result
The test product received has achieved a >4-log reduction when tested under the condition stipulated in this report, against Feline coronavirus (surrogate of SARS-CoV2) when tested at a concentration of neat(3%).
4 Log Reduction
Scientists use a logarithmic scale to see the growth of virus. Log reduction stands for a 10-fold (or one decimal point) reduction in virus, meaning the disinfectant reduces the number of live viruses by 90 percent for every step of the division. A 4-log kill reduces the colony or viruses by a 99.99% reduction.
Media Contact:
holista@wer1.net (+65 67374844)
karishma@wer1.net (+65 84792656)
Corporate Affairs & Business Opportunities
Dr Rajen Manicka: rajen.m@holistaco.com
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
MicroPort CardioFlow Completes Raising New Round of Funds
SHANGHAI, CHINA, Apr 16, 2020 – (ACN Newswire) – On April 15, 2020, MicroPort Scientific Corporation (Stock code: 00853) ("MicroPort"), announced that MicroPort CardioFlow Medtech Corporation ("MicroPort CardioFlow"), which is a subsidiary of MicroPort, had completed raising a new round of funds on the basis of a pre-money valuation of US$1.1 billion. The introduction of seven prominent strategic investors, who are CPE, Hillhouse Capital Management, Ltd., Lake Bleu Capital, Gamnat, China Reform Conson Soochow Overseas Fund I L.P., Gortune Artemis Limited, and 3H Health Investment Fund I, L.P., raised approximately US$130 million. After this round of fundraising, the investors will have an aggregate shareholding of 10.83% in MicroPort CardioFlow. J.P. Morgan Securities (Asia Pacific) Limited and Citigroup Global Markets Asia Limited acted as co-placement agents in the transaction.
MicroPort CardioFlow focuses on the research, development, manufacturing and marketing of comprehensive medical device solutions to the treatment of valvular heart diseases. Its independently developed VitaFlow Transcatheter Aortic Valve and Delivery System ("VitaFlow Valve System") received the registration certificate from National Medical Products Administration of China (NMPA) in July 2019. VitaFlow Valve System is the first approved Transcatheter Aortic Valve Implantation (TAVI) product using bovine pericardium as valve tissue in China, as well as the first TAVI product that features a double-layer PET skirt and a motorized delivery system in China. Accompanied by Alwide Balloon Dilation Catheter and Alpass Catheter Sheath Set, which were independently developed by MicroPort CardioFlow and approved by NMPA, VitaFlow Valve System provides a comprehensive full-set therapeutic solution for clinicians. The clinical data of VitaFlow Valve System have proved that the product can effectively improve the safety and efficacy of the TAVI procedure, which has been widely endorsed by industry experts and clinicians in practice. VitaFlow Valve System launched its official commercialization in August 2019. As of April 16, 2020, the products have entered a total of 51 hospitals with TAVI capacity, including Zhongshan Hospital Affiliated to Fudan University, Chinese Academy of Medical Sciences Fuwai Hospital, the Second Affiliated Hospital of Zhejiang University School of Medicine, and Wuhan Asia Heart Hospital.
Dr. Qiyi Luo, Chief Technology Officer of MicroPort and Chairman of MicroPort CardioFlow, said, "With about 10 years of committed development of its aortic valve business, MicroPort CardioFlow has become an influential player in the field of heart valve in China and been favored by the capital market. This round of fundraising will bring in more resources for the development of the company in research and development, manufacturing, market expansion, and the enhancement of its market competitiveness. We have every confidence that we will maintain rapid development in the niche market of medical devices for valvular heart diseases, so as to provide more patients with high-quality and accessible integrated therapeutic solutions to valvular diseases."
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Australian CRO Avance Clinical Designated an Essential Service as Strong Demand from Sponsors Continues Amid COVID-19 Crisis
Adelaide, AUS, Apr 9, 2020 – (ACN Newswire) – Leading Australian CRO Avance Clinical said there was still strong demand from Asian and US sponsors, and commended Australian sites that had risen to the challenge to deliver for Avance Clinical clients during this difficult time.
 |
Avance Clinical is a medium-sized full-service CRO known for its nimble and collaborative approach, with more than 20-years of experience in managing early phase trials.
Avance Clinical's Chief Strategist Ben Edwards said a key factor in sponsor demand is the speed and attractive cost of running trials in Australia. In particular, they include:
– The Australian Government financial rebate of more than 40% on clinical trial spend
– No IND required for clinical trials and streamlined regulatory processes
– Advanced medical, research and scientific community, leading investigators and KOLs, and modern medical facilities
Watch video – how we work here https://www.avancecro.com/
Avance Clinical CEO Yvonne Lungershausen, who has a background in pure research, said sponsors saw the value of running studies in Australia.
"In addition, Australia is not as hard hit by the COVID-19 crisis which has meant we can work with sites to deliver studies that might otherwise be put on hold, costing time and money and causing crippling delays to drug pipelines," said Ms Lungershausen.
"We are pleased to be the Australian CRO of choice for international sponsors," she said.
"Australia's reputation for FDA compliant scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for clinical trials."
For more information about the benefits of running your next study in Australia contact us: https://www.avancecro.com/contact-us/
About Avance Clinical
Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organisations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialised patient groups. Other benefits include:
1. The Government R&D grant means more than 40% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialised patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons.
Media Contact:
media@avancecro.com
Chris Thompson
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Novotech Data Shows Majority of Australian Sites are Open for Clinical Trial Activity
SYDNEY, Apr 9, 2020 – (ACN Newswire) – Asia-Pacific's largest specialist biotech CRO Novotech said the top 10 biotech sites in Australia were open for clinical trial activity with many sites modifying their practices to ensure continuity of operations.
View and Download the COVID-19 Australia Data Bulletin here. https://novotech-cro.com/covid-19-notice
The data is part of a new series prepared for Novotech clients detailing the current status of trials in the Asia-Pacific during the global COVID-19 crisis.
Novotech CEO Dr John Moller said the Bulletin series taps local knowledge of fundamentals in the sector and shows which countries in the region are able to support clinical research for Novotech and its clients during this time.
"While the situation is always evolving, Australia appears to be managing the crisis well. Our sites have changed how they manage trials in line with Australian Government health guidelines and most are still able to deliver the clinical trial services we need for our clients," said Dr Moller. "Study delays caused by COVID-19 can be rapidly addressed by activating new sites in Australia and Asia."
Australia has attractive start-up times, world leading investigators and research teams, and valuable rebates of up to 43.5% on clinical trial spend.
About Novotech
Novotech, established in 1996, is internationally recognized as the leading full-service contract research organization (CRO) in Asia-Pacific. Novotech provides clinical development services across all clinical trial phases and therapeutic areas and has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotech companies.
Novotech obtained the ISO 27001, the best-known standard in the ISO family, providing the requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. Visit http://novotech-cro.com.
For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert
Media Contact
Susan Fitzpatrick-Napier
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Digital Diagnostics AG: New 5 Minute Coronavirus Test Delivers Clear Results on Infection
Mainz, Germany, Apr 8, 2020 – (ACN Newswire) – A new type of sensor device from the German health technology company Digital Diagnostics AG can be used for immediate tests for the new SARS coronavirus. The SARS-CoV-2 MEMS 5 Minute Test(TM) is created as a pocket-size lab and can be used in four steps anywhere on-site by general practitioners, paramedics and nursing staff without any training. The first prototypes of the biosensor will be available by end of April with first production devices by mid-May.
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Compared to previously known rapid tests looking for the presence of antibodies in the test-liquid, the SARS-CoV-2 MEMS 5 Minute Test(TM) leads to a clear "YES" or "NO" result regarding the presence of the actual virus in the test fluid and eliminates the time and cost consuming transport of samples to a laboratory. The great advantage of this method is that the virus can be detected directly with a very high accuracy. In contrast, all other rapid tests known to date are based on the detection of antibodies. But antibodies are not detectable in plasma until 7 to 10 days after infection.
With the 5 Minute Test developed by digid, the SARS-CoV-2 virus can be measured using micro-electro-mechanical systems (MEMS) without the need for time-consuming sample preparation. The SARS-CoV-2 MEMS 5 Minute Test(TM) is based on cantilevers, which are integrated onto a microchip with the size of a fingernail. These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force. This makes them highly sensitive biochemical sensors. The cantilevers are coated with a capture layer of antibodies. When applied to the chip, these antibodies bind any viruses contained in the test fluid. When the SARS-CoV-2 virus binds to the capture layer, changes in surface tension cause a mechanical bending of the cantilevers, which generates an electrical signal on the chip.
By connecting the digital sensor to a secure analytics platform, the numerous sensor data can be linked with geodata and processed anonymously for big-data applications. This would enable the creation of truly accurate tools to detect emerging regional hotspots of virus spread in near-real-time. Newly emerging chains of infection can then be effectively contained. Restrictions on freedom of movement could also be much more flexible and regionally limited, and the scarce resources of health administrations and hospitals could be used much more purposefully and efficiently.
Press contact
Thomas Huber
semanticom GmbH
+49 151 14 96 58 10
digid-pr@semanticom.eu
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– Read our story on medium.com https://www.newsfilecorp.com/redirect/7kePhJE8
– LinkedIn https://www.newsfilecorp.com/redirect/er4AIJ0o
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/54256
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Novotech Data Shows Majority of Australian Sites are Open for Clinical Trial Activity
SYDNEY, Apr 8, 2020 – (ACN Newswire) – Asia-Pacific's largest specialist biotech CRO Novotech said the top 10 biotech sites in Australia were open for clinical trial activity with many sites modifying their practices to ensure continuity of operations.
 |
View and Download the COVID-19 Australia Data Bulletin here. https://novotech-cro.com/covid-19-notice
The data is part of a new series prepared for Novotech clients detailing the current status of trials in the Asia-Pacific during the global COVID-19 crisis.
Novotech CEO Dr John Moller said the Bulletin series taps local knowledge of fundamentals in the sector and shows which countries in the region are able to support clinical research for Novotech and its clients during this time.
"While the situation is always evolving, Australia appears to be managing the crisis well. Our sites have changed how they manage trials in line with Australian Government health guidelines and most are still able to deliver the clinical trial services we need for our clients," said Dr Moller. "Study delays caused by COVID-19 can be rapidly addressed by activating new sites in Australia and Asia."
Australia has attractive start-up times, world leading investigators and research teams, and valuable rebates of up to 43.5% on clinical trial spend.
About Novotech
Novotech, established in 1996, is internationally recognized as the leading full-service contract research organization (CRO) in Asia-Pacific. Novotech provides clinical development services across all clinical trial phases and therapeutic areas and has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotech companies.
Novotech obtained the ISO 27001, the best-known standard in the ISO family, providing the requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. Visit http://novotech-cro.com.
For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert
Media Contact
Susan Fitzpatrick-Napier
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
Israeli Biotech SuperTrans Medical Announces $2 Million Strategic Investment from South Korean Mediforum
Tel Aviv, Israel, Apr 7, 2020 – (ACN Newswire) – via NEWMEDIAWIRE — SuperTrans Medical ("SuperTrans"), a privately held biopharmaceutical company with initial focus on the discovery and development of novel antibiotics, today announced that leading South Korean biopharma Mediforum Pharm (KOSDAQ: 047920) will make a $2M investment in SuperTrans. In return, Mediforum will collaborate with SuperTrans in the manufacturing and commercialization of SuperTrans' products in Asia, including South Korea, China, and Japan. Additionally, Mediforum will fully commit and support SuperTrans' future drug development programs.
The SuperTrans technology was discovered by chemists Prof. Paul A Wender (Professor of Chemistry, School of Humanities and Sciences, and by courtesy, of Chemical and Systems Biology Stanford Medical School, Stanford University) and Prof. Lynette Cegelski (Professor of Chemistry, School of Humanities and Sciences), both on the Scientific Advisory Board of the company. Professor Wender's guanidinium-rich, molecular transporter technology, inspired by nature, is licensed from Stanford University by SuperTrans Medical and its partner, Mediforum. This technological approach could help bridge a gap to deliver urgently needed antibiotics to thwart multi-drug resistant bacterial pathogens.
In addition, SuperTrans is completing candidate assessments for the treatment of COVID-19 based on its transporter technology. The candidate compound will be aimed in preventing both viral and bacterial pulmonary infections. The company is currently preparing its drug development program.
SuperTrans Medical's R&D team consists of individuals from Major Pharma' with drug development successes, including antibiotics and HIV inhibitors. These are Dr. Lewis Neville, CEO, Dr. Jacob Rendell, CTO (Ex-Teva), Dr. Patricia Bradford (Ex-Wyeth, Novartis and AstraZeneca), Dr. Joseph Vacca (Ex-Merck and WuXi Apptec), Dr. Peter Warn (Ex-Evotec) and Prof. Itamar Shalit, a pediatric clinical infectious diseases specialist.
Mediforum is a Seoul-based pharmaceutical company which is specialized for researching and developing novel drugs against neuro-degenerative disease such as Alzheimer's disease and Parkinson's disease. "SuperTrans Medical is thrilled to partner with Mediforum as our lead strategic investor. We are looking forward to a long-term partnership to further develop and commercialize the SuperTrans technology," commented Lewis F. Neville, CEO of SuperTrans Medical. "In a short period of time, we have made significant inroads into the design and evaluation of different FDA-approved antibiotics that were conjugated to the company's unique transporter technology. This has already resulted in the identification of a number of compounds worthy of late stage development. Mediforum has identified the strength of our platform technology to improve the properties of existing FDA-approved antibiotics. Mediforum's investment will allow a lead antibiotic-conjugate to enter Phase 1 testing within 12-15 months."
"We are delighted to invest in SuperTrans. We have been impressed by their rapid progress during the last number of months that has culminated in the development of a number of lead compounds. We believe that their transporter technology can represent a paradigm-shift for the accelerated development of much needed antibiotics into human trials. Mediforum will proactively play its role as a strategic partner through the co-exchange of all research and development efforts. Although SuperTrans' technology is at a relatively early stage of development, we anticipate the launch of a new generation antibiotic for testing will be relatively fast. This is because the technology can be easily conjugated to existing FDA-approved antibiotics," commented Mr. Park Jaehyung, CEO of Mediforum. "Furthermore, SuperTrans is strengthening its pipeline through its support of Stanford University and other scholars. Also, SuperTrans is preparing for a Hong Kong IPO in 2022, which is highly attractive for Mediforum," further commented Mr. Park Jaehyung.
About SuperTrans Medical
SuperTrans Medical is a biopharmaceutical company developing novel antibiotics by improving the properties of existing, FDA compounds following chemical conjugation to a unique transporter technology called Guanidinium-Rich Molecular Transporter (GRMoTr). A main obstacle in the development of effective antibiotics is to effectively overcome the structural complexities of the outer bacterial membrane. This is particularly pertinent for Gram-negative bacteria. The GRMoTr bestows upon antibiotics, a vastly improved capability to breach the outer membrane and effectively eradicate Gram-positive and Gram-negative pathogens including multi-drug resistant strains.
About Mediforum
Mediforum Pharm is a brain healthcare specialized pharmaceutical company that discovers and develops treatment for degenerative brain diseases such as Alzheimer's and Parkinson's diseases among others. Currently, the company is aggressively expanding its R&D pipeline together with its rapidly growing prescription drug sales. Furthermore, Mediforum is actively engaging with overseas research institutes in order to expand operations beyond domestic borders and penetrate the global market.
For more information, contact:
Lewis F. Neville, PhD
CEO
SuperTrans Medical
lewis@supertransmedical.com
Eran Gilboa
CFO
SuperTrans Medical
eran@supertransmedical.com
Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com
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