Nextgen biotech company, a member of the Artgen Biotech Group (MOEX: ABIO), announced the launch of clinical trials of its gene therapy drug, Neovasculgen, for interstitial cystitis. The first patients have already received injections.
Mikhail Iosifovich Kogan, Doctor of Medical Sciences, Head of the Department of Urology and Human Reproductive Health at Rostov State Medical University and Director of the Research Institute of Urology and Nephrology at Rostov State Medical University, stated: “There are few mysterious diseases and conditions left in modern urology. One of them, in terms of understanding its etiopathogenesis, diagnosis, and treatment, is interstitial cystitis.” An effective curative therapy for the disease has yet to be developed. While various medications and surgical treatments are used, there are currently no drugs on the market capable of achieving long-term remission for interstitial cystitis.
Interstitial cystitis is a chronic, debilitating disease that affects adults and is one of the most common causes of chronic pelvic pain in women. Globally, approximately 9.5 million people suffer from interstitial cystitis. In Russia, around 180,000 people are affected by the disease, with an annual increase of 20,000 cases. In 30% of patients, the disease is mild and can be managed through lifestyle changes and over-the-counter medications. However, in 70% of patients, the disease is severe, requiring intensive treatment, including prescription drugs and surgical intervention. In severe cases, patients may experience urinary frequency of up to 50–60 times per day, urgent urges to urinate, blood in the urine, constant severe pelvic pain, and significant psychological changes.
Neovasculgen, a drug used in clinical practice to treat lower limb ischemia, is included in the list of essential medicines. It is the world’s first gene therapy drug based on the mechanism of “therapeutic angiogenesis” (therapeutic blood vessel growth). The drug has the potential to treat a range of conditions that require increased vascular density, including interstitial cystitis. According to preclinical studies, the injection of Neovasculgen into the bladder wall has demonstrated a positive therapeutic effect in experimental models of interstitial cystitis in animals.
Interstitial cystitis has two clinical subtypes: one with ulcerative lesions of the bladder mucosa, known as Hunner’s lesions, and one without. Since the treatment approaches for these subtypes differ, Nextgen will conduct parallel clinical trials for both types of the disease using two distinct protocols. Each trial will involve 180 patients.
-A double-blind, placebo-controlled, adaptive, multicenter, prospective, randomized, comparative, parallel-group study to evaluate the efficacy and safety of Neovasculgen for painful bladder syndrome/interstitial cystitis without Hunner’s lesions.
-A double-blind, placebo-controlled, adaptive, multicenter, prospective, randomized, comparative, parallel-group study to evaluate the efficacy and safety of Neovasculgen for painful bladder syndrome/interstitial cystitis with Hunner’s lesions.
NextGen, JSC is a resident of Medtech and the Lomonosov Cluster of the Vorobyovy Gory MSU Innovative Science and Technology Center. The company specializes in the development and implementation of gene therapy drugs and is working to expand the indications for the use of Neovasculgen.