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Health & Biotech
The ASX 200 Health Index (XHJ) is up by 1.5% at the time of writing, compared to the broader index which is up by 0.40%.
Mesoblast (ASX:MSB) jumped 10% after reporting data from its Phase 3 trial of rexlemestrocel-L in chronic heart failure patients.
The results were presented as a late breaking presentation at the American Heart Association’s annual seminar.
Mesoblast’s landmark study showed a significant relationship between the presence of systemic inflammation, and treatment benefit with rexlemestrocel-L for cardiovascular mortality including heart attacks or strokes.
A key finding was that a single dose of rexlemestrocel-L on top of standard of care reduced the incidence of heart attacks or strokes by 65% across all 537 treated patients, compared with standard of care alone.
And compared with standard of care alone, the addition of rexlemestrocel-L did not further reduce the frequency of hospitalisation for worsening heart failure symptoms, as previously reported.
Heart failure affects approximately 6.5 million people in the US, and 26 million people globally, with increasing prevalence and incidence. The mortality rate approaches 50% at 5 years.
Orthocell said the pivotal Ortho-ATI® shoulder tendon study database has been locked, and the data submitted for analysis.
Ortho-ATI is the first randomised cellular therapy study completed for this indication globally, as there are currently no proven long-term, non-surgical solutions to repair chronic shoulder tendon injuries.
The next step will involve pursuing a egulatory strategy to enable rapid approval by FDA.
ResApp has received IRB (FDA’s Institutional Review Board) approval to modify its US COVID-19 study to allow for recruitment at in-person COVID-19 testing clinics.
The US-based pilot clinical study aims to secure data to train an algorithm to identify COVID-19 through cough sounds recorded on a smartphone, using a gold standard PCR pathology test as a reference standard.
The company has received a Chinese patent for its LAG-3 related immunotherapy treatment for cancer, Efti, following the corresponding European and US patents announced in 2018 through to 2021.
The new patent is exclusively licensed to Immutep’s partner in China, EOC Pharma, and will expire on 8 January 2036.
Apiam Animal Health (ASX:AHX) +3.5%
Apiam’s distribution partner, Aurora Pharmaceutica,l has received US EPA notification to market the Xtend 21 Antimicrobial Surface Protectant product.
Xtend 21 has the potential to be applied to air filters, cool cells, loadout chutes, cabins and on trailers of livestock vehicles, enhancing antimicrobial surface protection.
Aurora Pharmaceutical meanwhile, is a rapidly growing veterinary pharmaceutical company, headquartered in the US with more than 10,000 veterinary customers.
Australian Clinical Labs (ASX:ACL) +3.5%
ACL has entered into a binding agreement to acquire Medlab Pathology, a leading Australian private pathology provider with two laboratories and 288 collection centres across NSW and QLD.
ACL will acquire the key business assets for $70m, with upfront consideration of $60m paid at completion.
The payment also includes a deferred consideration of $5m on completion of CY22, and a further $5m subject to the achievement of non-COVID revenue retention hurdles.
The gut pathogens specialist said the USU, which is part of the US Department of Defence, will commence the production of the first batches of investigational medical products in November 2021, to support the planned clinical trial program of Travelan.
Travelan is a dietary supplement that has been clinically proven to reduce the risk of occasional diarrhea caused by contaminated food and beverages during travel.
Chimeric Therapeutics (ASX:CHM) unchanged
Chimeric has presented positive initial Phase 1 clinical data results for its CLTX CAR T therapy.
The study showed that CLTX CAR T cells were generally well tolerated, and none of the patients experienced a dose limiting toxicity.
These results will give Chimeric confidence as higher dose levels and dual routes of administration commence.
PharmAust has signed agreements with NZ-based Veterinary Specialists Auckland and Intuit Regulatory, to expand its canine Phase 2b lymphoma studies into New Zealand.
These studies will support the preparation of the upcoming Phase 3 monepantel trial, anticipated to commence in May 2022.
At Stockhead we tell it like it is. While PharmAust and Apiam Animal Health are Stockhead advertisers, they did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
