Biomedical company Polaris Group (北極星) yesterday said that it would continue developing its cancer treatment ADI-PEG 20, but with a new approach, following a setback in a clinical trial.
A phase III study of the effectiveness of ADI-PEG 20 as a second-line treatment for hepatocellular carcinoma (HCC) failed to demonstrate overall survival (OS) benefits, the company said in a statement on June 6.
The study showed that median OS was 7.8 months for patients receiving ADI-PEG 20, which was not significantly better than the 7.4 months for patients given a placebo.
Polaris Group chief executive officer Wu Bor-wen (吳伯文) told an investors’ conference that despite the setback, the company has formed a solid plan moving forward from the clinical trial.
ADI-PEG 20 is arginine deiminase (ADI) formulated with polyethylene glycol, with an average molecular weight of 20 kilodaltons (PEG 20), and the treatment is designed to degrade arginine, an amino acid crucial to tumor cell metabolism and the growth of certain cancers, Wu said.
An analysis of the clinical trial data showed that patients with arginine depletion for seven weeks or longer had a median OS of 12.5 months, compared with 6.3 months for patients with arginine depletion of less than seven weeks, Wu said.
“This outcome shows that the treatment is effective against cancer, as arginine-starved cancer cells are unable to survive and grow,” Wu said.
In addition, Wu said the study showed that ADI-PEG 20 was more beneficial for patients who have never had prior treatment with Nexarvar, a sorafenib-based drug for treating diseases including kidney and liver cancer, and thyroid carcinoma.
For some patients, prior treatment with Nexarvar reduced the arginine deprivation ability of ADI-PEG 20, and the company’s new treatment might be more effective as a first-line treatment, Wu said.
Nexarvar induces argininosuccinate synthase (ASS) expression, an enzyme that catalyzes the synthesis of argininosuccinate from citrulline and aspartate, which makes ADI-PEG 20 ineffective as a monotherapy option, Wu said.
The company said it would explore alternative roles for ADI-PEG 20, such as using the treatment as a component of combination therapy as a first-line treatment, as well as using higher dosages to promote longer arginine depletion, Wu said.
Wu added that in March, the firm began a number of clinical trials for ADI-PEG 20 on treating mesothelioma of the lungs and pancreatic cancer, and that regulatory approval for one of the indications might come in about 2018.
To obtain market approval, the company is to file biologics license applications with regulators, and expand its sales potential by testing more ASS-deficient tumors in trials, Wu said.
Combination research is becoming more common in new cancer drug development, but testing each combination candidate would require a tremendous amount of time, Polaris Group medical affairs executive vice president John Bomalaski said.
The company will also improve patient selection so that those who are more likely to benefit from ADI-PEG 20 are included in future clinical trials, Bomalaski said.
‘SWASTICAR’: Tesla CEO Elon Musk’s close association with Donald Trump has prompted opponents to brand him a ‘Nazi’ and resulted in a dramatic drop in sales Demonstrators descended on Tesla Inc dealerships across the US, and in Europe and Canada on Saturday to protest company chief Elon Musk, who has amassed extraordinary power as a top adviser to US President Donald Trump. Waving signs with messages such as “Musk is stealing our money” and “Reclaim our country,” the protests largely took place peacefully following fiery episodes of vandalism on Tesla vehicles, dealerships and other facilities in recent weeks that US officials have denounced as terrorism. Hundreds rallied on Saturday outside the Tesla dealership in Manhattan. Some blasted Musk, the world’s richest man, while others demanded the shuttering of his
ADVERSARIES: The new list includes 11 entities in China and one in Taiwan, which is a local branch of Chinese cloud computing firm Inspur Group The US added dozens of entities to a trade blacklist on Tuesday, the US Department of Commerce said, in part to disrupt Beijing’s artificial intelligence (AI) and advanced computing capabilities. The action affects 80 entities from countries including China, the United Arab Emirates and Iran, with the commerce department citing their “activities contrary to US national security and foreign policy.” Those added to the “entity list” are restricted from obtaining US items and technologies without government authorization. “We will not allow adversaries to exploit American technology to bolster their own militaries and threaten American lives,” US Secretary of Commerce Howard Lutnick said. The entities
Minister of Finance Chuang Tsui-yun (莊翠雲) yesterday told lawmakers that she “would not speculate,” but a “response plan” has been prepared in case Taiwan is targeted by US President Donald Trump’s reciprocal tariffs, which are to be announced on Wednesday next week. The Trump administration, including US Secretary of the Treasury Scott Bessent, has said that much of the proposed reciprocal tariffs would focus on the 15 countries that have the highest trade surpluses with the US. Bessent has referred to those countries as the “dirty 15,” but has not named them. Last year, Taiwan’s US$73.9 billion trade surplus with the US
Prices of gasoline and diesel products at domestic gas stations are to fall NT$0.2 and NT$0.1 per liter respectively this week, even though international crude oil prices rose last week, CPC Corp, Taiwan (台灣中油) and Formosa Petrochemical Corp (台塑石化) said yesterday. International crude oil prices continued rising last week, as the US Energy Information Administration reported a larger-than-expected drop in US commercial crude oil inventories, CPC said in a statement. Based on the company’s floating oil price formula, the cost of crude oil rose 2.38 percent last week from a week earlier, it said. News that US President Donald Trump plans a “secondary
RSS