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.
Taiwan would remain in the same international network for carrying out cross-border payments and would not be marginalized on the world stage, despite jostling among international powers, central bank Governor Yang Chin-long (楊金龍) said yesterday. Yang made the remarks during a speech at an annual event organized by Financial Information Service Co (財金資訊), which oversees Taiwan’s banking, payment and settlement systems. “The US dollar will remain the world’s major cross-border payment tool, given its high liquidity, legality and safe-haven status,” Yang said. Russia is pushing for a new cross-border payment system and highlighted the issue during a BRICS summit in October. The existing system
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) is expected to grow its revenue by about 25 percent to a new record high next year, driven by robust demand for advanced technologies used in artificial intelligence (AI) applications and crypto mining, International Data Corp (IDC) said yesterday. That would see TSMC secure a 67 percent share of the world’s foundry market next year, from 64 percent this year, IDC senior semiconductor research manager Galen Zeng (曾冠瑋) predicted. In the broader foundry definition, TSMC would see its market share rise to 36 percent next year from 33 percent this year, he said. To address concerns
Intel Corp chief financial officer Dave Zinsner said that a formal separation of the company’s factory and product development divisions is an open question that would be decided by the chipmaker’s next leader. Zinsner, who is serving as interim co-CEO following this month’s ouster of Pat Gelsinger, made the remarks on Thursday at the Barclays technology conference in San Francisco alongside co-CEO Michelle Johnston Holthaus. Intel’s struggles to keep pace with rivals — along with its deteriorating financial condition — have spurred speculation that the next CEO would make dramatic changes. That has included talk of a split of the company’s manufacturing
PROTECTIONISM: The tariffs would go into effect on Jan. 1 and are meant to protect the US’ clean energy sector from unfair Chinese practices, the US trade chief said US President Joe Biden’s administration plans to raise tariffs on solar wafers, polysilicon and some tungsten products from China to protect US clean energy businesses. The notice from the Office of US Trade Representative (USTR) said tariffs on Chinese-made solar wafers and polysilicon would rise to 50 percent from 25 percent and duties on certain tungsten products would increase from zero to 25 percent, effective on Jan. 1, following a review of Chinese trade practices under Section 301 of the US Trade Act of 1974. The decision followed a public comment period after the USTR said in September that it was considering
RSS