The Health June/July 2021 | Page 7

| Foreign News |

JUNE-JULY , 2021 | THE HEALTH

07

Takeda ’ s dengue vaccine reinforced by long-term safety

TAKEDA Pharmaceutical Company Limited ( Takeda ) announced that its dengue vaccine candidate ( TAK-003 ) demonstrated continued protection against dengue illness and hospitalisation , regardless of an individual ’ s previous dengue exposure , with no important safety risks identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunisation against Dengue Efficacy Study ( TIDES ) trial .
TIDES enrolled more than 20,000 healthy children and adolescents ages four to 16 years in dengue-endemic countries in Latin America and Asia .
“ Dengue epidemics occur suddenly and hospitals can become overwhelmed with severe disease cases and people seeking testing ,” said LakKumar Fernandoi , M . D ., Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever , Negombo General Hospital , Sri
NEW data released on June 18 , 2021 shows that Australia ’ s Viraleze™ anti- Covid nasal spray is more than 99.9 per cent effective against three of the four deadliest variants of the SARS-CoV-2 virus .
The results from the renowned Scripps Research Institute in the US confirm that SPL7013 , the active ingredient in Viraleze™ , is highly active against the Alpha ( UK ), Beta ( South Africa ) and Gamma ( Japan / Brazil ) variants of SARS-CoV-2 – which spread rapidly and increase the risk of mortality .
The results hold significant promise for Viraleze™ – developed by Melbourne-based biopharmaceutical company Starpharma ( ASX : SPL ) – in the fight against new and emerging variants of SARS-CoV-2 , as several countries begin their long-awaited opening of international borders .
The additional testing by the Scripps Institute showed that the Viraleze™ active , SPL7013 , was virucidal within 30 seconds to 1 minute and achieved more than
SMITH + NEPHEW , the global medical technology business , announced on June 16 , 2021 the launch of its Real Intelligence suite of enabling technology solutions including its next generation robotics platform , the CORI Surgical System , in Australia and New Zealand .
Demand for robotic-assisted surgery for large joints in Asia-Pacific is forecast to grow ( 27.3 per cent between 2017 and 2027 ). In Australia alone , leading technologies , including robotics , are already utilised in nearly 50 per cent of all total knee procedures - a market with approximately 57,000 total
Lanka and a primary investigator of the TIDES trial .
“ Results from the long-term analysis of Takeda ’ s dengue vaccine candidate suggest that it could help with outbreak prevention , reduce rates of hospitalisation and protect people from dengue regardless of their previous exposure . Importantly , no important safety risks were identified .”
“ Our dengue vaccine candidate continued to provide protection against dengue throughout three years , and was especially robust in preventing hospitalisation ,” said

Viraleze effective against Alpha , Beta and Gamma Covid variants

99 per cent reduction of infectious virus against the Beta and Gamma variants , and more than 99.9 per cent within five minutes . For the Alpha ( UK ) variant , the Viraleze™ active ( SPL7013 ) achieved > 99.9 per cent reduction in virus within 30 seconds to one minute .
The findings indicate comparable potency for SPL7013 against all three variants of concern compared with original strains of the virus . The Delta ( India / B . 1.617.2 ) and Kappa ( India / B . 1.617.1 ) variants are planned to be tested when virus availability permits .
Professor Philippe Gallay , who led the Scripps Institute ’ s testing , said : “ We are impressed with the rapid and potent virucidal and antiviral activity of SPL7013 .
“ It is particularly exciting to see a product with this level of virucidal activity . The latest data is consistent with our previous data showing robust antiviral and virucidal effects of SPL7013 against the US strain of SARS-CoV-2 and suggests a mechanism of action that is not
Derek Wallace , VP , Dengue Global Program Leader at Takeda .
“ These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue .”
As previously reported , the TIDES trial met its primary endpoint of overall vaccine efficacy ( VE ) against virologically-confirmed dengue ( VCD ) at 12-months follow-up and all secondary endpoints for which there were a sufficient number of dengue cases ( measured at 18-months follow-up ).
The TIDES trial has been amended to include the evaluation of a booster dose to address the waning of overall VE observed over time ( from 12 through 36 months after the second dose ), largely driven by outpatient dengue .
Takeda intends to publish results of the 36-month exploratory analysis in a peer-reviewed journal this year .
impacted by mutations affecting the virus spike proteins .”
Dr Jackie Fairley , CEO of Starpharma , said : “ These variants continue to spread across the globe and challenge public health authorities . Given its mechanism of action , Viraleze may prove to be particularly beneficial as a complementary layer of protection at large gatherings of people – including the Tokyo Olympics .
Dr Fairley said Starpharma has now reported data on the potent antiviral properties of SPL7013 against the Alpha , Beta , Gamma variants of coronavirus , as well as original strains from the US , Europe , and Australia . “ This data is in addition to previously announced data for other pandemic-causing coronaviruses , SARS-CoV and MERS-CoV .”
Viraleze™ is registered for sale in Europe , the UK and India , and is available through one of the UK ’ s largest pharmacy chains , LloydsPharmacy , and online at viraleze . co .

Next generation robotics platform launched

knee arthroplasty and 3,700 unicompartmental procedures per year .
The CORI Surgical System is small , portable , and designed for today ’ s crowded operating rooms . It includes new camera technology that is over four times faster , offers more efficient cutting with twice the volume , and aims to deliver a faster cutting time .
The CORI System uses surgeon-controlled robotics , and its modular design will enable it to be scaled across the orthopaedic service line .

Briefs

Financing for ischemic stroke therapy
RAPIDPULSE , Inc , a privately-held medical device company developing a novel aspiration system to treat ischemic stroke , announced on June 24 , 2021 the closing of a $ 15 million Series A financing . The financing was led by Santé Ventures who was joined by Epidarex Capital , Hatteras Venture Partners , Broadview Ventures , and Syntheon .
RapidPulse plans to use the proceeds to advance its RapidPulse™ Cyclic Aspiration System through expanded clinical evaluation and build out its platform of proprietary catheters .
The RapidPulse™ system was developed by Syntheon , a medical device incubator focused on developing next generation medical devices .
Their various products , commercialised by the largest and most trusted medical device companies in the world , have treated over 50 million patients globally in applications ranging from laparoscopic surgery , cardiovascular , and flexible endoscopy . Syntheon has over 200 issued patents since its inception over 20 years ago .
“ We are pleased to have partnered with an outstanding investor syndicate to move our RapidPulse™ technology forward in the clinic ,” said Sean McBrayer , CEO of Syntheon who will also serve as initial CEO of RapidPulse .
Pancreatic cancer treatment approval for clinical trial
PRESTIGE BioPharma Limited ( PBP ) specialising in the development of antibody therapeutics , announced that French National Agency for the Safety of Medicines and Health Products ( L ’ Agence nationale de sécurité du medicament , ANSM ) has approved a Phase 1 / 2a clinical trial of its first-in-class anti-PAUF monoclonal antibody , PBP1510 , for the treatment of pancreatic cancer .
The clinical trial will be conducted in the Research Institute against Digestive Cancer ( IRCAD ) based in Strasbourg , France , in pancreatic cancer patients who have an overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor ( PAUF ) found in majority of pancreatic cancers . PBP ’ s affiliate , Prestige Biologics will be providing drugs for the clinical trial .
Pancreatic cancer is a highly aggressive malignancy originating in the exocrine or endocrine pancreatic cells suspected to be caused by poor diet , smoking , and genetic factors .
Currently , the only curative options are limited to surgical resection in combination with adjuvant chemotherapy .
In addition , using cutting-edge technology , high counts of live bacteria can be maintained in the drinks , so that consumers can truly enjoy high-potency , quick-acting and long-acting probiotic beverages .
This is an epoch-making technological innovation . In the modern age with increasing consumer awareness , Japan takes the lead in the health food industry in Asia and has successfully utilised scientific research and development to make truly good products .— The Health