TAIPEI, May 5, 2023 /PRNewswire/ -- Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. The median overall survival (mOS) was 12.6 months, which was 48% better than the 8.5 months mOS in the Phase III clinical study of the standard of care (nab-paclitaxel + gemcitabine). Compared to the current first-line treatments for this difficult to treat cancer, this study demonstrated that Antroquinonol in combination with SOC showed a significant survival advantage.

Antroquinonol(HOCENA)picture from Golden Biotechnology Corp.

The Phase II Antroquinonol clinical trial is a single-arm Phase I/II study to evaluate the safety and efficacy of Antroquinonol in combination with SOC (nab-paclitaxel + gemcitabine) as a first-line treatment for stage IV metastatic pancreatic cancer. The first stage of the study focused on treating pancreatic cancer with oral Antroquinonol at doses of 200 mg three times daily and 300 mg three times daily for a duration of 4 weeks; to determine the maximum tolerated dose regimen for Antroquinonol in combination with SOC. The expanded Phase II trial will focus on the efficacy of Antroquinonol in combination with SOC. This is a multi-national and multi-center clinical trial enrolling patients in the United States, Taiwan and South Korea.

The interim report on the metastatic pancreatic cancer trial (Full Analysis Set) demonstrated clear clinical benefits for patients treated with Antroquinonol together with SOC

Key Results:
* Median progression-free survival (mPFS): 5.3 months
* Median overall survival (mOS): 12.6 months
* Six-month overall survival rate (OS rate): 86%
* Twelve-month overall survival rate (OS rate): 60%

Compared to the results of the Phase III study for the SOC (nab-paclitaxel + gemcitabine combination), Antroquinonol in combination with SOC has much better median overall survival (mOS), six-month and twelve-month overall survival rates (OS rates). The overall survival rates for Antroquinonol combination therapy, standard treatment (nab-paclitaxel + gemcitabine), and gemcitabine monotherapy were 12.6, 8.5 and 6.7 months respectively; six-month overall survival rates were 86%, 67% and 55% respectively; and twelve-month overall survival rates were 60%, 35% and 22% respectively.

In comparison to the FOLFIRINOX treatment for metastatic pancreatic cancer, in terms of median overall survival and six-months overall survival rates; again the Antroquinonol in combination with SOC demonstrated superiority. Data showed that the overall survival (OS) between Antroquinonol combination with SOC and FOLFIRINOX were 12.6 and 11.1 months respectively; six-month overall survival rates were 86% and 76% respectively; twelve-month overall survival rates were 60% and 48% respectively. Compared to current first-line treatments, Antroquinonol in combination with SOC has also demonstrated better survival advantage.

Existing SOC for pancreatic cancer frequently causes adverse events that can result in disruptions to treatments. For Antroquinonol combination with SOC,  blood-related adverse events, including neutropenia, thrombocytopenia, anemia and leukopenia, were significantly reduced in all grades in this trial. For non-hematologic adverse events such as fatigue, hair loss, peripheral neuropathy and dehydration; the events were similarly reduced in the Antroquinonol combination.

The phase 2 study of Antroquinonol in combination with SOC demonstrates the high possibility of a new first-line agent for the treatment of Stage 4 metastatic pancreatic cancer. With its oral formulation and low side-effects, Antroquinonol can be an exciting addition to the current IV chemotherapies and immediately offer patients the possibilities of better treatment outcomes.

The results of this interim analysis is exceptionally encouraging. Antroquinonol in combination with standard treatment appears to have a significant survival advantage over current first-line treatments for metastatic pancreatic cancer. Patients on Antroquinonol also demonstrated reduced adverse event which significantly improve their quality of life. GoldenBiotech looks forward to continuously monitoring the patients to evaluate if the results can be sustained. Overall, for many years, there have been no new treatment for this difficult to treat cancer. Antroquinonol may be the treatment that offers new hope to pancreatic cancer patients."

Antroquinonol is a new chemical entity (NCE) with multiple functions. It has been developed that shows promising results in the treatment of cancers. Antroquinonol inhibited Ras and Ras-related GTP-binding protein activation through inhibition of protein isoprenyl transferase activity, leading to activation of autophagy and associated mode of cell death in cancer cells. More than 30 percent of all human cancers including 95% of pancreatic cancers are driven by mutations of the RAS family of genes. Antroquinonol also has impacts on the PI3K/ AKt / mTOR pathway, affecting the autophagy and apoptosis of cancer cells. Its ability to target cancer cells without harming normal cells reduces the likelihood of drug resistance and increases its safety profile. Additionally, it can be taken orally, providing a convenient treatment option for patients. It may represent a significant advancement in the treatment of pancreatic cancer with its multiple functions and high safety profile.

The global pancreatic cancer treatment market size was $2.15 billion in 2021 and is expected to grow from $2.48 billion in 2022 to $6.85 billion in 2029 at a compound annual growth rate of 15.7%. This growth is being driven by the increasing incidence of pancreatic cancer, the growing demand for personalized cancer therapies, and the rising adoption of innovative therapies.

The results of this clinical trial could have a major impact on the treatment of metastatic pancreatic cancer. If these results are confirmed in future studies, Antroquinonol in combination with standard treatment could challenge to be the new standard of care for this devastating disease.

(FORWARD-LOOKING STATEMENTS):

The statements contained herein may contain certain forward-looking statements relating to Golden Biotechnology Corporation (the “Company”) that are based on the current beliefs and expectations of the Company’s management as well as assumptions made by and information currently available to the Company’s management. These forward-looking statements include, but are not limited to, statements relating to the Company’s business prospects, future developments, trends and conditions in the industry and geographical markets in which the Company operates; the Company’s inventions, patents, patent applications, strategies, plans, objectives and goals; the Company’s ability to control costs; and statements relating to prices, volumes, operations, margins, overall market trends, risk management and exchange rates. These statements can be identified by the use of words such as “anticipate,” “estimate,” “believe,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “should,” “seek,” “will,” “expect,” “objective,” “projection,” “forecast,” “goal,” “guidance,” “outlook,” “effort,” “target” or the negative of these terms or other comparable terms. However, the absence of these words does not mean that the statements are not forward-looking. These forward-looking statements are, by their nature, subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

These forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update or reflect subsequent events or circumstances, changes in expectations or the occurrence of unanticipated events. All forward-looking statements herein are qualified by these cautionary statements and there can be no assurance that the actual results or anticipated developments will be realized or, even if substantially realized, that they will have the expected consequence to or effects on the Company’s business or operations.