Every year in Russia, surgeons conduct 300,000 surgeries to remove tumors from breasts, stomach, colon, uterus, thyroid and prostate as well as melanomas during the first year after diagnosis. According to current standards, malign tumors are removed along with nearby lymph nodes. With the existing methods of lymphatic system examination, surgeons often can’t see which of the nodes should be removed and remove all the nodes surrounding the tumor. Russian company Skandia Eko and Russia’s leading cancer research institute, National Medical Research Institute of Radiology, developed Limfotropin, medication that can help to detect affected lymph nodes, or sentinel lymph nodes. Medication will be significantly cheaper than similar American drugs and will help to reduce damage from surgery. Currently, Skandia Eko is looking for RUR 35 mio ($554K) for clinical research of Limfotropin, CEO Artur Iskandarov told Invest Foresight at a Medical Investment Club conference.
No excessive damage
Sentinel lymph nodes are part of the peripheral immune system where first metastatic lesions grow in case of breast, stomach, colon, uterus, thyroid, prostate cancer and melanoma. Examination methods such as ultrasound, computer tomography, magnetic resonance imaging, radiologic diagnostics cannot accurately confirm micrometastases in lymph nodes and stages of their development. Moreover, radionuclide and fluorescent lymphography require high expertise and additional expensive equipment.
Herzen Moscow Oncology Research Institute (branch of the Healthcare Ministry’s National Medical Research Institute of Radiology) and Skandia Eko developed a method of visualizing sentinel lymph nodes and regional lymphatic vessels during a surgery. Limfotropin is injected into the tumor area after which it spreads to the first-order lymph node with lymphatic fluid and colors it bright blue, which allows detecting sentinel lymph nodes during a surgery. The affected lymph nodes are then removed for examination.
Limfotropin helps to make the surgery less invasive and to avoid removing healthy lymph nodes. In pilot trial on mice and rats, Limfotropin demonstrated a high diagnostic capability and safety due to its low toxicity. Surgeons of Russia’s leading oncology centers such as Blokhin Russian Cancer Research Center, Lopatkin Research Institute of Urology and Interventive Radiology, and Petrov National Medical Cancer Research Center expressed interest in the medication.
Less expensive than US analogs
In the United States, injections of 1% Lymphazurin and its analog 1% Isosulfan Blue are used for sentinel lymph nodes visualization. The medications’ cost reaches $1K for 50 mg, or 5ml ampule, making it hardly affordable for common usage at cancer treatment clinics. Such medications are not registered either in Russia or the Eurasian Economic Union. In Russia, radionuclide and fluorescent lymphography is currently in use, with no color lymphography products available.
“Every year, some 300,000-350,000 surgeries are conducted in Russia in patients within a year after the diagnosis of cancer has been made. In roughly half of the cases, Limfotropin could be potentially used for seven or eight localizations”, Artur Iskanderov says.
The expected price for Limfotropin is $75-100 for a 5ml ampule, which is about 10-12 times cheaper than its US-manufactured analog.
Patenting and investments
Skandia Eko and Herzen Moscow Oncology Research Institute have patented Limfotropin in April 2019. Currently, Skandia is seeking investments of RUR 35 mio (554K) for clinical testing and purchasing equipment for substance synthesizing, which is Skanida Eko’s know-how. 1% Limfotropin aqueous solution will be manufactured under contract by a pharmaceutical company. Skandia is selling 35% of its shares for RUR 35 mio. The payoff period is three years. The company expects to receive compensation for clinical testing from Russia’s Ministry of Industry and Trade.
Within three years, a total of 30,000 Limfotropin ampules will be manufactured, with the product sold mostly in Moscow and the Moscow Region through direct deliveries to cancer clinics. The medication sales are planned to begin in 2021. The product’s Russian market is estimated at RUR 500 mio ($7.9 mio), with the annual demand of 100,000 ampules. Preliminary testing has been conducted at Herzen Moscow Oncology Research Institute, where clinical testing is planned as well. Speaking of the project’s main risks, Artur Iskanderov names failure to register Limfotropin on time as the registration period for medications usually tends to drag on. Yet, due to the Oncology Research Institute to prepare all documentation, the risk is minimal.
Limfotropin is not the first medication to have been developed by Skandia Eko. In 2017, the company patented Novostimin, s substance for manufacturing skin antiseptics, veterinary drugs, and cosmetic products.
By Natalia Kuznetsova