A groundbreaking experimental anticancer drug, presently identified only as AOH1996 and developed by researchers at the City of Hope, has brought about renewed optimism that a cure for cancer is on the horizon.

The experimental drug, which begins clinical trial today (August 2), may be effective in treating a range of cancers including breast, prostate, brain, ovarian, cervical, skin, and lung cancers.

“No one has ever targeted PCNA as a therapeutic because it was viewed as ‘undruggable,’ but clearly City of Hope was able to develop an investigational medicine for a challenging protein target,” explained Dr Long Gu, lead author of the study and an associate research professor in the Department of Molecular Diagnostics and Experimental Therapeutics at Beckman Research Institute of City of Hope.

AOH1996 is a proliferating cell nuclear antigen (PCNA) inhibitor, and it functions by blocking key enzymes necessary for tumour cell growth, potentially leading to a halt in tumor progression.

The trial aims to study the drug’s safety, determine the optimal dosage, and evaluate its effectiveness in halting tumour growth. It is not the first cancer treatment drug to enter clinical trials, as currently Pfizer and Boehringer Ingelheim both have their own cancer drugs currently in clinical trials. There is also a Cuban drug CimaVax-EGF, a vaccine used to treat cancer, specifically non-small-cell lung carcinoma (NSCLC).

The inclusion criteria for the trial are strict and will require patients to meet specific conditions. Participants must be 18 years or older and have an Eastern Cooperative Oncology Group (ECOG) performance status of two or lower. They should have a life expectancy of at least three months and documented informed consent to participate in the study.

Patients with solid tumours (breast, colon, bladder, prostate, and lung) that have not responded to standard therapies or those who have chosen not to undergo standard treatments will be eligible for enrolment. Additionally, among other criteria, the trial also requires participants to meet specific medical criteria, including maintaining a certain blood count, liver function tests, and kidney function assessments to ensure their eligibility for the study.

As part of the clinical trial’s primary objectives, researchers aim to determine the maximum tolerated dose (MTD) of AOH1996 and identify any dose-limiting toxicities (DLT). This information will be crucial in establishing the recommended phase 2 dose (RP2D) of the drug for further investigation.

In the trial, patients will receive AOH1996 orally twice daily for 28 days in each cycle. The cycles will repeat every 28 days unless there is disease progression or the patient experiences unacceptable toxicity. Once the study treatment is completed, patients will be closely monitored for 30 days to evaluate their response to the drug and any potential side effects.