Starpharma reports positive outcome on Phase 2 trial

Starpharma Holdings (ASX:SPL) announced positive final results from the completed Phase 2 clinical program of DEP docetaxel.

The Phase 2 trial objectives were met, with endpoints demonstrating encouraging anti-tumour activity of DEP docetaxel when administered as a monotherapy, or in combination with other anti-cancer agents, nintedanib or gemcitabine.

Results exhibited encouraging signs of efficacy in heavily pre-treated patients with advanced, metastatic cancers, including pancreatic and non-small cell lung cancer (NSCLC), as well as in patients with advanced gastro-oesophageal cancers.

The clinical trial also demonstrated the ability of DEP docetaxel to effectively target tumours, with treated patients showing that tumour tissue achieved tissue levels of docetaxel up to 60 times higher than levels in blood.

The Phase 2 clinical trial program also confirmed the product’s improved tolerability profile versus conventional docetaxel.

“These clinical findings, in addition to Starpharma’s recently reported results from the DEP cabazitaxel and DEP irinotecan programs, will feed into Starpharma’s ongoing commercial discussions for the products,” said Starpharma CEO, Dr Jackie Fairley.


dorsaVi up almost 30pc on US deals

The wearable sensor health tech company, dorsaVi (ASX:DVL), jumped 27% this morning after announcing that it has signed two new contracts with leading US institutions for a total value of ~US$113,000.

One agreement was with a leading hospital system, Norton Healthcare, while the other was with a leading US University, Georgia Southern University.

The deals will support research on dorsaVi’s product line, while enhancing its client base and diversifying the company’s revenue stream.

“These contracts are a great endorsement of our platform capability, and further validation of our growing presence in the US healthcare market,” said dorsaVi CEO, Dr Andrew Ronchi.

“Our continued alignment with top-tier institutions reflects our dedication to generating shareholder value as we continue to partner with leading companies across the healthcare market.”


Telix submits BLA application to the US FDA

Telix Pharma (ASX:TLX) announced that it has submitted its Biologics License Application (BLA) to the US FDA for its investigational positron emission tomography (PET) imaging agent, TLX250-CDx, in clear cell renal cell carcinoma (ccRCC).

With the BLA submission, Telix has also now requested a Priority Review, which if granted, would support an expedited review time.

If approved by the FDA, TLX250-CDx will be the first targeted radiopharmaceutical imaging agent for kidney cancer to be commercially available to patients in the US.

“This is a major milestone and achievement for Telix, which paves the way for a commercial availability for patients in the US in 2024, subject to regulatory review and approval,” said Telix’s CEO, Dr Christian Behrenbruch.

This submission is based on Telix’s earlier successful global Phase III ZIRCON study, and allows Telix to open an expanded access program in the US and a named patient program in Europe.

These programs allow access to TLX250-CDx outside of a clinical trial to patients for whom there are no alternate options.


Neurotech completes patient recruitment in Phase 2/3 trial

Neurotech International (ASX:NTI) has announced the completion of patient recruitment of the Phase 2/3 NTIASD2 clinical trial for children with Autism Spectrum Disorder (ASD).

The trial has recruited a total of 56 patients with Level 2 (requiring substantial support) and Level 3 (requiring very substantial support) autism.

All patients were enrolled at the Paediatric Neurology Unit at Monash Medical Centre, through the trial’s Principal Investigator Professor Michael Fahey.

The results of the NTIASD2 clinical trial are expected in Q1 of calendar year 2024.

“The results of this trial will inform our discussions with the Therapeutic Goods Administration to understand our pathway to market approval in Australia as our first market opportunity, where the prevalence of autism is estimated at 1 in 50 across the population, representing a 40-fold increase in the last 20 years,” said Neurotech executive director, Dr Thomas Duthy.


Tissue Repair gets third US patent

Tissue Repair (ASX:TRP) announced that its third US Patent application has been approved by the US Patent and Trademark Office (USPTO).

The patent covers the Glucoprime compound and molecule for any application whatsoever. This patent now affords the protection for a variety of further applications to commercialise the company’s core technology platform.

Glucoprime and its variants is the underlying technology platform behind Tissue Repair’s lead drug candidate TR987 for the treatment of Venous Leg Ulcers (VLUs) and its TR Pro+ cosmeceutical product.

There are no known alternative processes from which to produce this proprietary biological polysaccharide molecule.

The technology has broad applications in any environment in animals or humans where there is a wound, when applied topically and/or within the body.

Tissue Repair says it is now in exploratory discussions with parties on potential additional overseas distribution agreements for selected territories.


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