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LTR Pharma Ltd (ASX:LTP) has reached a significant milestone in the launch 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). This achievement is a crucial step forward in LTR Pharma's strategy to introduce Spontan to the market, providing faster access to the treatment through the APS.
Spontan stands out among existing ED therapies due to its unique mechanism of action, utilizing intranasal delivery technology for a PDE5 inhibitor. The nasal cavity, known for its highly vascular nature, facilitates rapid and even absorption of the drug, enabling it to take effect within 10 minutes or less at a lower dose than traditional oral PDE5 tablets.
Unlike the more restrictive Special Access Scheme (SAS), the APS allows registered medical practitioners to prescribe Spontan to a broader range of patients with erectile dysfunction, streamlining access for those who may benefit from this innovative treatment. LTR Pharma's Chief Scientific Officer, Professor Eric Chung, a globally recognized expert in urology and men’s health, is leading the milestone prescription under the APS.
Professor Chung highlighted the benefits of the Authorised Prescriber Scheme, noting that it allows for offering Spontan to a wider range of patients who could benefit from its rapid onset of action. He emphasized that Spontan has the potential to significantly improve the quality of life for men struggling with ED, providing a new treatment option for those seeking a more spontaneous solution.
LTR Pharma's Chairman, Lee Rodne, underscored the importance of this authorization under the APS, stating that it highlights the urgent need for a faster-acting ED treatment and Spontan's capacity to meet this significant unmet demand. The scheme also enables authorized healthcare professionals to gain valuable, hands-on experience with Spontan in real-world settings.
Chimeric Therapeutics Advances CAR-T Cell Therapy with Successful GMP Manufacturing
Chimeric Therapeutics Ltd (ASX:CHM), a clinical-stage biotech focused on cell therapies, has successfully completed Good Manufacturing Practice (GMP) manufacturing for its CHM CDH17 CAR-T cells. This milestone enables the treatment of the first clinical participant in the company’s Phase 1/2 trial.
The participant's cells were collected at the Sarah Cannon Cancer Centre in Nashville, USA, and transported to the contract manufacturing site. The Phase 1/2 trial 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 tumors.
Following GMP manufacturing, the CHM CDH17 CAR-T cells passed specification testing and quality assurance review and are currently being transported back to the clinical trial site for infusion. Dr. Kelly Thornburg, CHM's head of technical operations, expressed satisfaction with the successful manufacturing run, noting that it represents the culmination of more than two years of dedicated effort to develop a GMP-compliant manufacturing process that supports this patient population in need of new treatment options.
Immuron Secures US Defense Funding for Travelan Development
Immuron Ltd (ASX:IMC) has announced a new research agreement with the US Department of Defense, securing $3.5 million (~US$2.3 million) in funding to advance the development of Travelan, an orally administered passive immunotherapy that reduces the likelihood of contracting travelers' diarrhea.
The focus of this new agreement is to develop an enhanced formulation of Travelan, potentially expanding its coverage as a therapeutic measure against military-relevant diarrheal pathogens. Immuron stated that the research will leverage the extensive experience of the US Department of Defense's human infectious disease vaccine programs, targeting key protective antigens of major enteric bacterial pathogens, including campylobacter, shigella, and enterotoxigenic E. coli strains not present in the current product formulation.
Travelan is already listed on the Australian Register for Therapeutic Goods and is sold as a licensed natural health product in Canada and as a dietary supplement for digestive tract protection in the US. According to the 2019 Department of Defense Infectious Disease Threats Prioritisation Panel, infectious diarrhea is the most common illness reported by travelers to developing countries and among US troops deployed overseas.
