2ⁿᵈ Edition of the Cancer R&D World Conference 2026

Introduction and Background: Cancer is now among the top global health dilemmas and its global disease burden is alarming.  There are many different types of cancers but for the purposes of this study, we shall focus only on Leukemia particularly, Chronic Myeloid Leukaemia (CML). African leukaemia incidence data from the South African National Cancer Registry for  2011, reported that,  the leukaemia incidence  was a total of 750 new cases of leukaemia (437 male, Age – Standardized Rate (ASR) 2.33 per 100,000 population and 313 female, ASR 1.33 per 100,000) that were reported with no specific classification of the type of leukaemia mentioned (Egbuna, Chukwuebuka, et al., 2023)  Chronic myeloid leukaemia (CML) a specific Cancer of the blood,  is a chronic myeloproliferative disorder which accounts for 15 to 20 percent of all adult leukaemias (Nelde, Annika, et al., 2023). According to the Leukemia epidemiology and burden of disease in South Africa 2025, there were 2 001 new cases of leukaemia and 1 244 deaths reported, with an incidence rate of 4.11 per 100,000 and mortality rate of 3.01 per 100,000 population indicating a sharp growing by the year 2025.  Cassava (Manihot esculenta Crantz): has been used traditionally as a food for ages and is non-toxic, abundantly available and its pharmaceutical formulations could be affordable. Currently, this carbohydrate polymer is being investigated for Drug Delivery pharmaceutical applications due to its safety, availability, and cost-effectiveness. (L.W.J. Holleman and A. Aten. Rome. FAO Agricultural Development Paper No.21. 2025) However, Edible Cassava Starch IDFs presents with challenges, of formulation, optimization, and proof of efficacy in animal and human studies.  Overcoming these constraints may assist in developing Drug Delivery Systems using its intraoral dispersible films (IDFs) which could enhance the bioavailability and hence activity of some Nano structured lipid carrier (NLCs) loaded with anticancer drugs that exhibit poor oral bioavailability.
 

Purpose of Study: Therefore, the purpose of this study is to come up with natural cost effective and efficacious pharmaceutical products with enhanced bioavailability that could overcome the formulation challenges of the Edible Cassava Starch IDFs, optimize the formulations, and prove their efficacy as a drug delivery system for Nano structured lipid carrier (NLCs) for Anticancer drugs because Cancer are on the rise globally.

Aim and objectives: This study aims at developing and investigating the possibility of using the IDFs made from Edible Cassava Starch as a drug delivery system for intraoral pharmaceutical Nano structured lipid carrier (NLCs) { Liquid Lipid Black Seed Oil and Solid Lipid Stearic Acid } formulated to enhance bioavailability and the activity of the natural Anticancer drugs (Allicin, Curcumin, and Resveratrol ) loaded into the Edible Cassava Starch films targeting chronic myeloid Leukaemia to overcome the high cost of the current cancer therapies, the subsequent development of Resistance due to mutations, metastasis, Severe side effects and the possible drug - drug interactions (Salmon, Matthew, et al., 2026).  
 

Methods: Pharmaceutical formulation techniques of IDF dosage form using adjuncts and other excipients will be employed to formulate the Edible Cassava Starch IDFs. We will optimize these formulations for stability and drug loading using the Experimental Microsoft excel add in programme called Experimental deign by (Yeaton, Steppin and Werner). Bioavailability studies will be conducted in cell lines to establish their efficacy. Therefore, the investigation will include:

(1) A control of Allicin, Curcumin, Resveratrol, Honey flavoured Black Seed oil (Nigella Sativa), and Tyrosine Kinase Inhibitors (TKIs) conditions, Imatinib, Dasatinib, and Nilotinib (e.g., standard dosages) that could serve as references to determine the effectiveness of these natural intraoral novel formulations. These controls are important in validating the results. This will be studied from the literature review for validation purposes.

(2) The determination of the physicochemical characteristics of the IDFs by means of Compound Light Microscopy, TGA, DSC, ATR/FTIR and XRD, SEM, TEM, LC – MS, ZETASIZER, Dissolution, Permeation, Moisture content, Folding Endurance, Swelling Index, Weight Uniformity, and Texture analysis. Taste Testing using the artificial tongue in substitute of Human ethics and Human volunteers.

(3) The measurement of the concentration of Allicin, Resveratrol, and Curcumin, and Honey flavoured Black Seed oil (Nigella Sativa to establish their therapeutic doses using the developed HPLC and / or UV / Vis Spectrophotometric methods.

(4)The Bioassay will include the administration and measurement of the effects of Allicin, Resveratrol and Curcumin, Honey flavoured Black Seed oil (Nigella Sativa), Nano structured lipid carriers (NLCs) emulsified with polysorbate 80 (Tween 80) loaded in the cassava starch IDFs on mammalian cell lines for drug Loading and evaluating the Growth inhibition of the formulations on Colone (Caco-2) and prostate (LNCaP) (Human embryonic kidney 293 cells), and / or on Myeloid Leukemic cell lines to evaluate and investigate the cytotoxic  activity  and safety profiles of these novel Nano formulations on Chronic Myeloid Leukaemia as compared to that of the Molecular Responses (MRs) of the three sequential TKIs i.e. Imatinib followed by Dasatinib and  Nilotinib TKIs standard documented Chemotherapies.

(5) The assessment of the ex vivo Entrapment efficiency (%EE) will be investigated and the drug release and permeation characteristics of the optimum IDFs determined in simulated saliva using a Franz diffusion cell.
 

Ethical considerations: Full Ethics permission from the Ethical University committees will not be necessary because this study will not involve the use of live Human or Animal tissue. However, exemption from full animal ethics will be applied for because animal tissue from euthanized animals that are sacrificed for other purposes will be used.  Allicin, Resveratrol, and Curcumin will be sourced from DB Fine Chemicals Pty. South Africa or from tenders on the SMU list. Other Natural Anti – Cancer drug the Black Seed oil (Nigella Sativa) will be sourced from the local markets.
 

Results: Statistics of the results obtained will be analyzed employing the Stata software package, or the Microsoft excel add in programme called Experimental Deign by (Yeaton, Steppin and Werner). This Box-Behnken experimental design will be used to establish the significance of the dependent and independent variables and for the interpretation of the results.
 

Conclusions: Collected Data will be analyzed employing the Surface Response Plots derived from the Statistical Experimental design software package and from the Bio analysis to prove that the Nanostructured lipid carrier (NLCs) of Allicin, Resveratrol and Curcumin, could enhance the bioavailability and activity of these essential natural anticancer drugs. The list of drugs including Allicin, Resveratrol and Curcumin could later be expanded to other drug molecules that exhibit low oral bioavailability where their IDFs could also be formulated. This study could demonstrate that the IDFs of Edible Cassava Starch loaded with Allicin, Resveratrol and Curcumin, Honey flavoured Black Seed oil (Nigella Sativa) could significantly enhance the bioavailability and activity of some key essential natural anticancer drugs leading to future improved Cancer therapeutic outcomes.