Golden Biotechnology Corp. had completed the registration and listed its new drug study in Clinicaltrials.gov of NIH for the trial “Determine Function of Antroquinonol in Combination with SOC(standard of care ) Dugs in First Line Metastatic Pancreatic Cancer.”
ClinicalTrials.gov is a registry and results database of publicly and privately supported research studies conducted in the United States and around the world. Sponsors or investigators of certain clinical trials are required by U.S. law to register their trials on and submit summary results to ClinicalTrials.gov. Other international policies also require trial registration.
The registered clinical trial is a Phase I/II study designed to evaluate Antroquinonol in combination with SOC(standard of care ) drugs ,nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma.
In May 2017, Golden Biotechnology Corp. (GBC) received FDA IND approval to execute a safety and effectiveness trial of Antroquinonol combined with current standard treatment for patients with pancreatic cancer.
Pancreatic cancer is a highly fatal carcinoma, and about 80% of patients are diagnosed at the terminal stage. Overall, the 5-year survival rate of pancreatic cancer patients is less than 5%. There are several treatments for pancreatic cancer, such as surgery, radiation therapy, and chemotherapy. A Standard regimen of gemcitabine (Gemzar®) with nab-paclitaxel (Abraxane®) is the most common first-line therapy option for pancreatic cancer. According to the results of the clinical trial, patients who received this combination therapy succeed in a median overall survival (mOS) of 8.5 months, compared with 6.7 months for patients treated with gemcitabine alone. Obviously there is still much more room for improvement on the effectiveness for pancreatic cancer so GBC will devote to the study of novel Antroquinonol regimens and to benefiting the quality of life by decreasing adverse effects.
In 2015 GBC’s new drug candidate, Antroquinonol (Hocena®) received the orphan drug designation( ODD) from US FDA in treatment of pancreatic cancer, Acute Myeloid Leukemia (AML) and Hepatocellular Carcinoma (HCC). In 2017 European Commission (EC) has also granted orphan drug designation to Antroquinonol for treating pancreatic cancer. Now, we are pleased to have received FDA acceptance for our IND application to evaluate the safety and effectiveness of Antroquinonol in combination with standard nab-paclitaxel [Abraxane®]) and (gemcitabine [Gemzar®] for pancreatic cancer. It is inferred that patients with early-stage pancreatic cancer will be able to enroll in this upcoming clinical trials.
There are three ongoing clinical trials of Antroquinonol including US FDA multi-center Phase 2 trials for the treatment of non-small cell lung cancer (NSCLC), Taiwan FDA (TFDA) trial of Antroquinonol in patients with hyperclolerterolemia and hyperlipidemia and US FDA the effectiveness and safety clinical trial of Antroquinonol in combination with nab-paclitaxel plus gemcitabine in first line metastasis pancreatic cancer.