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Simcere Pharmaceutical Group (NYSE: SCR) has successfully completed a Phase IV clinical trial of Endostar, its patented cancer drug, in patients with non-small cell lung cancer (NSCLC). Endostar, a Class-1 drug with an anti-angiogenesis mechanism, was approved by the SFDA in 2005 to treat NSCLC. Simcere said the drug, which was administered as an adjunct to chemotherapy, “significantly” improved outcomes without causing additional adverse effects.

The Phase IV trial was the largest such trial ever conducted in China and the first Phase IV trial of Class-1 drug to be completed under China’s new re-registration law.

Endostar is a modified version of recombinant human Endostatin designed to stop the growth of cancer by starving it of oxygen and other nutrients. Simcere added a nine-amino acid sequence to Endostatin that enhanced protein purification, solubility and stability, which increased the efficacy.

The trial was designed as an open label, prospective, and multi-center study. Overall, 2725 subjects were enrolled in the test between December 2006 and June 2009. Mean Survival Time (MST) was 17.6 months, 1-year survival rate was 64%, 2-year survival rate was 20%, and median Time to Tumor Progression (TTP) was 7.4 months. Objective Response Rate (ORR) was 24%, and Disease Control Rate (DCR) was 76%.

Endostar is currently being studied as a treatment for other types of cancer, and some investigators have reported it was effective for the treatment of pleural/ascetic fluid and Gliomas (a type of brain tumor).

In 2009, revenues from Endostar (or Endu, as it is also known) dropped 42% year-over-year to 58 million RMB ($8.5 million), though Q4 results showed a 6% increase to 34 million RMB ($5 million) from the year-earlier quarter.

In March 2009, Simcere and San Francisco-based Epitomics announced a collaboration to develop anti-cancer drugs using RabMAb®, Epitomics’ humanized rabbit monoclonal antibodies.

Disclosure: none.

Source: Simcere's Cancer Drug Makes Significant Headway in Trials