Introduced US clinical pain treatment drug’KLS-2031′ at the 5th Future Medicine Spring Forum
Academia is drawing attention as to whether gene pain treatment drugs made from adenovirus will emerge as the dark horse of Kolon Life Sciences.
It is reported that a gene therapy drug developed for patients suffering from chronic pain showed good effects regardless of gender in animal experiments. If the treatment is used for a patient, it is expected that a single injection will produce similar effects to systemic administration.
Kim Soo-Jung, the managing director of Kolon Life Sciences, who made a presentation at the Spring Forum held by the Future Medical Research Foundation on the 7th, announced the’development of pain treatment materials using adeno-associated virus carriers’. The treatment mechanisms and effects were explained.
Humans have nociceptive pain due to external stimuli such as wounds or bumps, while neuropathic pain felt by damage to sensory nerves. According to Kim Soo-jeong,’neuropathic pain’ occurs not when a strong stimulus or external wound is the cause, but when a sensory nerve is damaged. When such nerve damage progresses, the pain pathway is excessively activated and becomes more sensitive to pain. As a result, in severe cases, it may lead to a state of feeling pain even though there is no stimulation.
Managing Director Kim Soo-jeong selected three genes that can be used as gene therapy for such pain. GDNF, a glial neurogenic growth factor that protects against nerve damage, interleukin-10, which relieves protein inflammatory responses and promotes immunity, and GABA, a representative neurotransmitter that stabilizes brain excitement, was used. GAD65 plays a role in restoring an already activated neurological state to its original state.
Adenovirus (AAV), which safely carries this gene into the body, has been proven in its safety and has the advantage of long-term treatment effects. In particular, AAV exhibits a therapeutic effect by expressing genes even in a state that remains as a chromosome fragment even if the genetic transducer does not enter the cell.
In order to compare the group consisting of two genes and three combinations of genes before injecting the selected gene, the optimal treatment effect was tested through animal experiments. As a result, the optimal treatment effect was obtained from all three genes. Showed.
Finally, the combined genetic material through the dose response test of KLS-2031 was injected into the cervical cavity epidural (between the vertebrae) of the mouse. KLS-2031, which entered the nerve cells through the dorsal root ganglion, was found to have a therapeutic effect during follow-up for 12 weeks in animal experiments.
Through animal experiments, Kim Soo-jeong identified the degree of nerve damage, sedation effect of the inflamed area, and the degree of excitement of nerve cells. Results The treatment effect began to be evident from a dose of 10 to the 9th power of VG or higher, regardless of gender. From the 10th power of 10, the effect was improved close to that of rats with normal nerves.
According to Managing Director Kim Soo-jeong, clinical trials are currently being conducted in the United States to prove the safety and efficacy of a single double-blind single dose of KLS-2031. Clinical trials are expected to be divided into cohorts of three groups, ranging from high-dose to low-dose.
Managing Director Sujeong Kim said, “The KLS-2031 treatment showed therapeutic effects with just one injection. The clinical trials currently in progress in the United States have been designated by the FDA’s Fast Track.”