Ever since the inception of humankind, we all have relied on plants to find cures for a number of health conditions. But as time passes, the shift towards chemical drugs such as antibiotics have become highly relevant. Nonetheless, we now have studies proving that plant-based drugs, when manufactured on par with other pharmaceuticals, are capable of producing promising results.
BELX Biopharmaceutical Co. Ltd., is one such leading research and development biotech company venturing into the realm of botanical drugs to treat cancers and other chronic diseases.
Improving treatment efficacy and the quality of life for cancer patients have long been unmet medical needs, says the Taipei-based biotech company. Taking the advantages of the company lead candidate drug’s excellent safety profile and unique features, BELX is gearing toward making a difference.
“The botanical drug we are developing offers a novel approach in treating various types of solid tumors. Improved therapeutic outcome and less side effects can be achieved simultaneously with our drug in single use and/or in combination with existing cancer drugs.” said Ian Lee, COO at BELX BioPharmaceutical Co. Ltd.
In a recently completed phase I clinical trial, the company’s candidate drug, BEL-X, not only showed to be extremely safe but also gave very promising results, maintaining quality of life, based on the evaluations of body weight changes, SF-36 questionnaire scores, and ECOG performance scores, according to the company’s COO.
Although many developed nations worldwide have not been made increasingly aware of the reliance on plant-based drugs, it is found that at least two-thirds of the entire world depends on botanical drugs for meeting their primary healthcare needs.
Despite the fact that we as a whole have been using plants for medicinal uses, lack of regulatory support in the past and, as a results, clinical trials and formal studies were the factors that greatly limited researchers from developing botanical drugs to their fullest potential.
Things have changed.
“Such preparations [botanical drugs] have historically been the basis for many (most) traditional medicines but have not usually been developed clinically in such a way as to provide confirmation of their safety and efficacy and importantly their consistency such that they provide predictable clinical outcomes patient to patient and reproducibly over time. There are numerous unmet medical needs where botanical drugs can contribute to their solution,” reads a review study.
According to the Food and Drug Administration (FDA), “a botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. A botanical drug's special features require consideration and adjustment during the FDA review process.”
CDER issued a Botanical Drug Development Guidance for Industry to take into consideration these features and to facilitate development of new therapies from botanical sources.
BELX manufactures botanical drugs on par with pharma giants and follows a thorough six-step process, which also includes clinical trials and producing plant-based pharmaceutical interventions the world can rely on.
The primary drug produced by the Taiwanese pharma company, BEL-X, is derived from one single plant whose medical effects were well documented in an ancient Chinese medical book. Modern R&D methods that include preclinical animal toxicology tests, as well as cGMP manufacturing standards have validated that BEL-X is not only an effective medication, but also has very low toxicity levels.
“BEL-X has a unique and novel mechanism of action. It can decrease and balance ROS (reactive oxygen species) in tumor cells resulting in reduction of tumor malignancy,” said Lee.
The startup primarily focuses on creating assets and out-licensing their interventions. As of now, the phase I clinical trial has been completed and based on what the startup reports, the results have been promising. With a plan to become public in three to five years from now, BELX is currently focusing on initiating subsequent clinical trials and seeking out co-development opportunities.
The COVID-19 pandemic has affected businesses’ progress and growth in a few areas. That said, BELX is aiming to complete the multiple phase II clinical trials by 2024-25. It is currently backed by Industrial Technology Investment Corporation and is looking to raise series B funds for fueling their clinical trials and R&D efforts.
BELX is being led by a core team comprised of the key members of the original R&D group, which initiated the development of BEL-X in 2000, from Industrial Technology and Research Institute, as well as experienced individuals from a wide spectrum of backgrounds such as molecular biology, biochemistry, pharmacy, and chemical engineering. Dr. Shau-Feng Chang, the original group and project leader, is now the CEO of BELX. With the leadership and integrated expertise, this team is committed to successfully commercialize BEL-X in the time to come.
SPONSORED BY SMEA, MOEA