Drug development programs: Anti-infection
Nemonoxacin: Once-a-day oral and IV, with excellent activity toward MRSA and VRSA
TaiGen has completed a Phase II study of the novel non-fluorinated quinolone Nemonoxacin for Community Acquired Pneumonia (CAP). The top-line Phase II data met the primary endpoint of non-inferiority to Levofloxacin, the leading quinolone on the market. Nemonoxacin has a broad spectrum of activity against gram-positive, gram-negative bacteria and atypical pathogens. Importantly, Nemonoxacin possesses first-in-class activity against MRSA and vancomycin-resistant pathogens. Nemonoxacin’s safety results were similar to those seen with Levofloxacin and consistent with the favorable safety profile observed in earlier Phase I trials.
Enrollment for the second Phase II trial in patients with diabetic foot infection (DFI) has been initiated to demonstrate anti-MRSA activity with oral dosing of Nemonoxacin. TaiGen plans to commercialize Nemonoxacin in greater China and ASEAN countries, at the same time forming marketing and development alliances in other parts of the world.

HCV NS3-4A: Protease inhibitors
Pre-clinical development on compounds targeting HCV is underway. Selected candidates have superior activity against all three genotypes, wild-type and mutant viruses selected by other leading drugs in clinical development with potential once-a-day dosing.
Drug development programs: Stem cell mobilizer
TG-0054: Stem cell mobilizer for stem cell transplantation, chemosensitization, ischemic tissue repair and ocular neo-vascularization – Answers to critical medical needs
TG-0054 is a potent and selective chemokine receptor antagonist. This molecule rapidly mobilizes stem cells and progenitor cells from the bone marrow into peripheral circulation. A Phase I trial in healthy volunteers has been completed with excellent safety and PK/PD data.
TaiGen is initiating Phase II trials for stem cell transplantation in cancer patients. This molecule also mobilizes hematological cancer cells hiding in the bone marrow, a major cause for disease recurrence. Application of this molecule prior to chemotherapy could eliminate the residual disease and extend disease-free survival time (a chemosensitizer).
Severe intermittent claudication, myocardial infarction and non-hemorrhagic stroke are major medical conditions not yet have effective therapeutics. TG-0054 effectively enhanced blood flow in a mouse ischemic limb model, increased blood vessel formation and improved limb functions. The molecule also greatly reduced the infarct size in a rat experimental stroke model. Myocardial infarction is another clinical indication TaiGen is seeking a co-development partner.
Macular degeneration (AMD) and diabetic retinopathy (DR) are caused by neovascularization inside eyes. In preclinical disease models, topical application of TG-0054 was able to seal leaky vessels and block ocular neo-vascularization.