Cells and pieces of the tumors were detached from the tumor, and analysis of urine samples showed large amounts of cells that had taken up the medicine. The tumor also showed evidence of uptake of Alpha1H and apoptosis, which is a beneficial form of cell death. Advanced molecular analyses also showed interesting and specific responses in tumors treated with Alpha1H, for example that Alpha1H switching off the expression of a large number of different cancer genes, which proved to be an important milestone.

The figure gives an overview of the placebo-controlled study and treatment of bladder cancer with Alpha1H. The images show how Alpha1H is administered and how different effects can be evaluated using clinical techniques and in different patient samples. Patients secrete large amounts of cells, often containing the drug, the tumor shrinks in size and analysis of immune responses provides important information on the effect on tumor tissue.

An immune response with strong anti-tumor potential was identified in the bladder of treated patients using advanced protein analysis techniques. The immune response was rapidly activated by Alpha1H after the first treatment and developed over the one-month treatment period. The immune response was also shown to increase with the treatment dose.
The activation of the immune system is another important mechanism of action that explains the potential of Alpha1H. Through the immune system, the tumor can be attacked and neutralized, as Alpha1H creates a multifunctional therapeutic environment in the tissue.

Recurrent acute cystitis, or recurrent urinary tract infection (UTI), is a very common disease in women. Approximately 60% of women will experience a symptomatic UTI in their lifetime. Of these, 20-40% will experience a further episode of cystitis, and between 25-50% will experience multiple recurrent episodes (AUA Website). The disease can be very distressing and lead to a significant impact on quality of life, especially for women who experience frequent recurrent infections. The treatment and management of recurrent UTIs, especially with increasing antibiotic resistance, is a global challenge that also generates high healthcare costs. Recurrent UTIs are usually treated with short courses of antibiotics, and some patients may also receive preventive treatment or other non-antibiotic strategies to reduce the risk of future infections.

Bladder Pain Syndrome (BPS), also known as interstitial cystitis, is a chronic disease involving bladder pain and discomfort estimated to affect between 4 to 12 million people in the United States, with the majority of cases being women (approximately 80-90%) (ICHelp)(BladderSmart). BPS causes chronic pain and discomfort in the bladder, often without an infection or other identifiable cause. The disease significantly affects quality of life and requires long-term management and treatment.

Patients with BPS have severe pain and other symptoms, which are socially disabling. As conventional painkillers are not effective, some patients are treated with morphine or surgery, often without lasting effects. The compound anakinra (IL-1RA), patented by the company for the treatment of bladder pain conditions, has shown promising effects in patients receiving off-label treatment. Pain scores decreased after treatment and quality of life increased in this severely disabled patient group. In addition, the laboratory tests showed a convincing reduction in pain molecules after treatment, suggesting a direct effect of the treatment at the molecular level.

Hamlet BioPharma is therefore continuing the clinical programme with a controlled phase II study in this patient group. The study was initiated with a screening phase, to identify patients who responded to treatment. A significant proportion of patients treated with anakinra responded favorably to treatment.

Source:https://www.transparencymarketresearch.com/ non-muscle-invasive-bladder-cancer-market.html

Source: Data are estimated values to represent market development from reports and research from the American Urological Association

Source:IMARC;https://www.imarcgroup.com
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