Salama H, et al. – A Phase II clinical trial was conducted to appraise the impacts of Ambovex in the treatment of hepatocellular carcinoma (HCC) in the liver. The effective and promising results of Ambovex as an immunological modulator in treating HCC were highlighted by this study.

Methods

• In order to assess the safety and efficacy of low-dose Ambovex oral spray in treating patients with HCC, a 6-month randomized clinical trial with an additional 3-month washing period (no treatment), was performed.
• 40 patients, with 33 in the treatment group and seven in the control group, were part of this study.
• Every month, the α-fetoprotein (AFP) levels were measured.
• At time zero and every 2 months thereafter, experts performed ultrasound.
• For patients in the treatment group, computed tomography (CT) scans were performed.

Results

• Although exhibiting the unpleasant taste, Ambovex proved to be safe, as there were no significant side effects.
• When compared to the control group at 3 months (P=0.0031) and at 6 months (P=0.007), AFP analysis showed a significant decrease in its level (α=0.05; 95% confidence interval) in the treatment group.
• As evidenced by a significant decrease in the lesion numbers and sizes, the ultrasound results showed improvement in the treated group.
• Results reported decrease of the lesions in 38% of treated patients from multiple to single with major improvements.
• Moreover, 35% of patients exhibited a decrease from multiple lesions to multiple lesions with minor improvements.
• On the other hand, 27% had stabilized lesions.
• As there was complete disappearance of the lesions after 6 months of treatment with Ambovex in two patients, CT scans in the treated group showed significant improvement.