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Health & Biotech
LTR Pharma (ASX:LTP) has announced a key milestone in the rollout of its nasal spray treatment for erectile dysfunction (ED) with the first select group of patients receiving Spontan under the Therapeutic Goods Administration (TGA) Authorised Prescriber Scheme (APS).
LTP says the milestone marks a significant step forward in the market introduction strategy with APS providing faster patient access to Spontan.
LTP’s lead asset is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor.
The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less, at a lower dose than traditional PDE5 oral tablets.
Unlike the case-by-case approach of the SAS, LTP says the APS allows registered medical practitioners to prescribe Spontan to a broader class of patients with erectile dysfunction, streamlining access for those who may benefit from the treatment.
The company says leading the milestone prescription under the APS is the company’s chief scientific officer Professor Eric Chung, an internationally renowned expert in the field of urology and men’s health.
“The Authorised Prescriber Scheme allows us to offer SPONTAN to a wider range of patients who may benefit from its rapid onset of action,” Chung says.
“This innovative nasal spray has the potential to significantly improve quality of life for men struggling with ED and offers a new treatment option, particularly for those seeking a more spontaneous solution.”
Chairman Lee Rodne says the authorisation of Spontan under the APS represents an important milestone for the company.
“It emphasises the pressing need for a faster-acting erectile dysfunction treatment option and highlights Spontan’s capacity to fulfil a significant unmet need for an on-demand ED solution,” he says.
“This scheme enables authorised healthcare professionals to obtain meaningful, hands-on experience with Spontan in real-world settings.”
A clinical-stage biotech focused on cell therapies, Chimeric Therapeutics (ASX:CHM) says it has completed Good Manufacturing Practice (GMP) manufacturing to enable treatment of the first clinical participant in its CHM CDH17 CAR-T Phase 1/2 trial.
CHM says the clinical trial participant’s cells were collected at Sarah Cannon Cancer Centre in Nashville in the US and transported to the contract manufacturing site.
The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in participants with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.
Following GMP manufacturing, CH says the CHM CDH17 CAR-T cells passed specification testing, quality assurance review, and are currently in transit back to the clinical trial site for infusion.
“We are delighted to have a successful manufacturing run for our first clinical trial participant,” CHM head of technical operations Dr Kelly Thornburg says.
“This milestone is the culmination of more than two years of focused effort to develop and implement a GMP compliant manufacturing process to support this patient population in need of new treatment options.”
Immuron (ASX:IMC) has announced a $3.5m (~US$2.3m) million funding for a new research agreement for the Naval Medical Research Command (NMRC), and Walter Reed Army Institute of Research (WRAIR) Silver Spring, MD, USA to advance the development of Travelan.
Travelan is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travellers’ diarrhoea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce.
IMC says the focus of the new research agreement is to develop an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrhoeal pathogens.
In an ASX announcement, the company says the work will use extensive experience of the US Department of Defense human infectious disease vaccine programs and will target key protective antigens of the major enteric bacterial pathogens campylobacter, shigella and entertoxigenic E. colistrains not present in the current product formulation.
Travelan is a listed medicine on the Australian Register for Therapeutic Goods. In Canada, Travelan is a licensed natural health product, while in the the US it is sold as a dietary supplement for digestive tract protection.
IMC says infectious diarrhoea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas as indicated by the 2019 Department of Defense (DoD) Infectious Disease Threats Prioritisation Panel.
At Stockhead, we tell it like it is. While LTR Pharma is a Stockhead advertiser, the company did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
