Experimental therapy RP-323 has shown anticancer activity against Hodgkin’s lymphoma in a Phase 1 trial. Its developer, Rich Pharmaceuticals, is now planning to evaluate the therapy in human clinical trials for the disease.
“We look forward to being able to commence clinical trials in the future to prove that using RP-323 alone or in combination with other anticancer agents will have significant therapeutic activity against Hodgkin’s lymphoma,” Ben Chang, CEO of Rich Pharmaceuticals, said in a press release.
RP-323 is a natural molecule isolated and purified from croton oil, which is obtained from the seeds of the purging croton, a plant native to Southeast Asia.
The investigative therapy not only modulates cancer cell behavior, including their survival and growth, but it also promotes immune cell proliferation. This suggests it could work as an immunotherapy to boost the immune system. Given its broad effect, RP-323 represents an attractive option to target cancer.
A Phase 1 study (NCT00004058) evaluated the anticancer potential of ascending doses of RP-323 in patients with relapsed or refractory blood malignancies or bone marrow disorders.
The trial, led by Roger Strair, MD and PhD, oncologist at The Cancer Institute of New Jersey, included 35 patients. Participants received RP-323 infusions for five days over two consecutive weeks, followed by a two-week resting period before another treatment cycle.
Only one patient — with relapsed or refractory Hodgkin’s lymphoma with a chest wall lesion — responded to the treatment. After three weeks of treatment with a 0.063 mg/m2 dose, the tumor had reduced from 7 cm to 2.5 cm in size. However, the tumor mass increased in size later on and treatment was stopped.
“A phase 1 clinical trial conducted at The Cancer Institute of New Jersey [has] shown that RP-323 treatment reduced a palpable tumor mass after three weeks in a patient with Hodgkin’s lymphoma,” Chang said.
While the patient relapsed in the trial, researchers believe the therapy candidate may have potential for Hodgkin’s lymphoma, supporting Phase 2 clinical studies.
Results from the trial were published in the journal Cancer Chemotherapy and Pharmacology, in the study “A Phase I clinical trial with 12-O-tetradecanoylphorbol-13-acetate for patients with relapsed refractory malignancies.”
Rich Pharmaceuticals has also tested RP-323’s safety and efficacy in patients with relapsed or refractory acute myeloid leukemia and myelodysplatic syndrome — a group of blood disorders where immature blood cells never reach a fully mature state.