Third Patient Enrolled in General Oncology’s SHARON Trial for Patients With Pancreatic or Breast Cancer and an Inherited BRCA1, BRCA2, or PALB2 Mutation
November 7, 2022
The trial is studying a novel approach designed to overcome drug resistance.
Boston—General Oncology, Inc. today announced the enrollment and dosing of the third patient in its SHARON Trial, a Phase 1 clinical trial evaluating a novel investigational treatment that uses chemotherapy and patients’ own stem cells for Stage IV pancreatic cancer and Stage IV, HER2-negative breast cancer in the setting of an inherited BRCA1, BRCA2, or PALB2 mutation. The trial is actively enrolling at major hospitals in Boston and New York.
“We are greatly encouraged by patient interest in this trial,” said Arnold Glazier, M.D., founder and Chief Science and Medical Officer of General Oncology. “Several retrospective analyses of DNA-damaging drugs and stem cells for advanced breast cancer have demonstrated long-term survival and probable cures in patients with a suspected or confirmed BRCA mutation. The SHARON Trial is the first prospective clinical trial to leverage this approach.”
About the Trial
The trial, a Phase 1 study, will enroll a total of approximately 10 to 18 patients with a BRCA1, BRCA2, or PALB2 mutation and either Stage IV pancreatic cancer or Stage IV, HER2-negative breast cancer. Each patient will receive two cycles of chemotherapy followed by an infusion of the patient’s own stem cells. The trial is open to people who have already received PARP inhibitors, as well as those who have not. There is no limit to the amount of prior chemotherapy that patients are allowed to have received.
The ClinicalTrial.gov identifier for the trial is NCT04150042 and the ClinicalTrial.gov listing is found at https://www.clinicaltrials.gov/ct2/show/NCT04150042.
About Melphalan, BCNU, Vitamin B12b, and Vitamin C
Each of the drugs in the trial has been FDA-approved for indications other than pancreatic and breast cancer. General Oncology holds patents on the use of the drug combination for the indications being studied in this trial. The drug combination is designed to take advantage of the hypersensitivity of BRCA-related cancers to drugs such as melphalan that damage cancer cell DNA. It is also designed to overcome drug resistance to melphalan and BCNU.
About BRCA-Related Stage IV Pancreatic and Stage IV Breast Cancer
Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive cancer with a grim prognosis: it is metastatic at diagnosis in a majority of patients and has a 5-year overall survival of 11%. Approximately 5–8% of patients diagnosed with PDAC have an inherited deleterious BRCA1 or BRCA2 mutation. At present, the NCCN-preferred treatment for metastatic BRCA-related pancreatic cancer is modified FOLFIRINOX or gemcitabine plus cisplatin. Other than surgical resection, systemic chemotherapy is the only major treatment that can currently improve survival for patients with locally advanced or metastatic pancreatic cancer.
Approximately 5–10% of breast cancers arise in patients with an inherited, deleterious BRCA1 or BRCA2 mutation; approximately 6% of those cancers are stage IV at diagnosis. The prevalence of Stage IV BRCA-related breast cancer in the U.S. is estimated to be approximately 8,000–16,000 individuals. Stage IV BRCA-related breast cancer is generally incurable.
About General Oncology, Inc.
General Oncology is a pharmaceutical company dedicated to developing highly effective and safe treatments for metastatic cancers. In addition to the investigational treatment in the SHARON Trial, the company has a pipeline of drug candidates for other solid tumors, as well as for myeloma, lymphoma, and leukemia. For more information about General Oncology, please visit www.generaloncology.com.
This release contains forward-looking statements about the investigational drug combination of melphalan, BCNU, vitamin B12b, and vitamin C, including statements about its potential benefits. There are substantial risks and uncertainties that could lead to actual results differing materially from the results expressed or implied by the statements. Risks and uncertainties include, but are not limited to, the possibility of unfavorable clinical trial results, an inability to continue recruiting patients or the possibility that patients will be recruited at a rate that is too slow to be sustainable, unfavorable decisions from regulatory authorities, clinical trial sites, institutional review boards, or the data and safety monitoring board that could lead to the early termination of the trial or that could otherwise materially adversely affect the trial, and competition from other therapies for breast and pancreatic cancer.