NatureCeuticals Sdn Bhd, a Malaysian pharmaceutical company is set to soon launch its Nation’s first plant-based drug to combat cancer-related fatigue which is the most common debilitating syndrome associated with cancer and its treatment. The drug known as Nuvastatic TM is based on a proprietary extract formulation of a herb known popularly as Cat Whiskers herb or scientifically identified as Orthosiphon stamineus.
Up to 70% of patients undergoing chemotherapy and radiotherapy suffer from mild to severe fatigue with complaints including lack of energy, malaise, lethargy, and diminished mental functioning that profoundly impairs their quality of life. Fatigue may appear mild in the early phase of the illness and worsens due to disease progression and associated treatments. This significantly affects the sufferer’s daily functioning and ability to cope with the majority of tasks in daily life as well as coping with ongoing disease treatment.
The mechanisms underlying cancer-related fatigue are extremely complex and not well understood as it involves many intertwined components from physiological to psychological. Biochemical substances produced by the invading tumors are postulated to contribute to the condition by inducing physiological disturbances. Treatment-related causes such as chemotherapy, biologic therapy, surgery, radiotherapy can also contribute significantly towards this phenomenon which may deter some patients from continuing with conventional treatment or become non-compliant. Depression and anxiety are some of the common psychological causes of fatigue in cancer patients and pose a great challenge in the management of advanced cancer.
In developed nations cancer fatigue is now widely recognized as an important medical condition and often considered an unmet medical need. International guidelines to perform clinical studies are now in place with the cost of treatments that can be covered by public health care and private insurance. The International Statistical Classification of Diseases and Related Health Problems (ICD) is the central pillar for health statistics that is governed and maintained by the WHO (World Health Organisation) for disease classification. ICD10 R53.0 which is a billable ICD code used to specify a diagnosis of neoplastic (malignant) related fatigue was introduced in 2019 highlighting the need to address the treatment standards of this condition.
Treatment options are often symptom-specific and limited which can include the use of anti-depressants, stimulants, blood transfusion, pain killers, and nutritional support depending on the symptoms and underlying cause. Other treatment method includes dietary support, exercise, music therapy, meditation, and many others. To date, no sole effective treatment can claim to address all the issues and components of cancer fatigue.
Back in 2013, NatureCeuticals had embarked on this mammoth task to explore the role of botanically sourced pharmaceuticals for the treatment of cancer-related fatigue. It’s Consultant Medical Director Professor Dr. Aman Shah Abdul Majid also the Scientific Director at the Centre for Angiogenesis and Natural Product Research, Quest International University said that NatureCeuticals has been aggressively pursuing botanical-based pharmaceutical research to address various medical conditions particularly cancer by employing advanced cutting-edge technologies and adherent to principles of modern molecular medicine to address various unmet medical needs.
“To produce quality botanical-based products that ensure the safety and clinical benefits for health is no easy task” he commented. “Complex and highly stringent regulatory requirements, pathways and standards are required to produce a prescription based botanical drug”.
He further commented that although the use of traditional herbal remedies to treat various human ailments have been well established for thousands of years, however seasonal variations and differing soil and planting methods, may cause fluctuations in efficacy and quality of the herbal products. “Furthermore the stability and absorption of many active phytochemicals can be rather poor and unpredictable”. The approach and concept of modern pharmaceutical technology to isolate and purify principal active compounds from natural products for their use as medicinal products may not necessarily be the best strategy.
The chemical isolation approach also may not be entirely beneficial for general health and may in fact further increase the risk of the development of some unknown medical complications related to toxicity. The isolation approach also causes a significant increase in the cost of production making the final product expensive.
Using advanced agriculture techniques, Natureceuticals coupled with its hi-tech extraction technology to produce botanical products for therapeutic use. Botanicals can potentially attain the same ‘drug’ standard similar to conventional pharmaceuticals. International regulatory authorities around the world are increasingly becoming acceptable to this concept with WHO, EMA, TGA, US FDA, and many others have product regulatory guidelines to enable herbal drugs to be registered with drug claims even for life-threatening diseases such as cancer.
Lanctos 75TM is the active formulation of Natureceuticals botanical drug Nuvastatic TM which employs a nanotechnology-based platform to enhance the absorption of the phytochemicals present in the Orthosiphon stamineus herb. The product is currently registered with the National Pharmaceutical Regulatory Agency of Malaysia under traditional medicine and awaiting due process for further evaluation for reclassification as a botanical medicine.
According to the clinical study, subjects who received NuvastaticTM had significantly lesser fatigue compared to the placebo arm. The patients were also found to have a significantly better quality of life and better overall health condition compared to the placebo. All NuvastaticTM treated groups showed a significant decrease in their urine F2-Isoprostane level which is an oxidative stress biochemical marker related to disease severity.
The clinical studies carried out support that NuvastaticTM is an effective anti-fatigue formulation that helps to improve the vitality and quality of life of cancer patients who are on chemotherapy and radiotherapy. NuvastaticTM treated patients were found to have significantly lower body pain and were less depressed when compared to placebo. Patients were also found to have better overall health compared to placebo.
Dr. Amin Malik Shah who is the founder and CEO of the company mentioned that the company is also making progress to register the drug with the US FDA as a botanical drug to treat cancer fatigue. If the drug is approved it will be available in many countries by mid of 2021. “Nuvastatic will benefit many cancer patients who suffer from severe fatigue.
This will help to fulfill some of the unmet needs of cancer patients”. Currently, Nuvastatic is also undergoing phase 2/3 clinical studies for breast and colon cancer. The study is expected to be completed before the end of 2021. All the studies are registered on clinicaltrial.gov.