(Taiwan) TaiGen continues advancing its drug development pipeline :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast staff)

8 April, 2008
Taipei, Taiwan-headquartered TaiGen Biotechnology Co., Ltd. made two announcements this week related to its drug development pipeline. The first was that positive data has come the Phase II study of nemonoxacin (TG-873870) in community-acquired pneumonia (CAP). The second was that enrollment for a Phase I trial under an IND from the US FDA had began for TG-0054, TaiGen's stem cell mobilizer.

TaiGen announced that nemonoxacin had met the primary endpoint of non-inferiority versus levofloxacin, the leading quinolone on the market. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Nemonoxacin possesses the first-in-class activity against MRSA (both hospital- and community-acquired) and vancomycin-resistant pathogens, according to the company. The multinational Phase II clinical trial, had an enrollment of 265 patients in three arms.

Reportedly, nemonoxacin demonstrated safety results that were similar to those seen with levofloxacin and were consistent with the favorable safety profile observed with nemonoxacin in earlier phase 1a and phase 1b trials.

Nemonoxacin was originally in-licensed by TaiGen from P&G Pharmaceuticals. P&G and TaiGen are seeking nemonoxacin licensees or co-development partners for the US, EU and Japan market.

For TG-0054, TaiGen's a stem cell mobilizer drug candidate, the company announced that enrollment for a Phase I clinical trial under an IND from the US FDA had began. TG-0054 will initially be developed for the indication of stem cell transplantation in cancer patients.

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