BSG005G for systemic fungal infections

Genes for biosynthesis of a polyene macrolide antifungal antibiotic have been cloned and characterized by scientists at NTNU (The Norwegian University of Science and Technology) and SINTEF (Scandinavia’s largest contract research organization), and the complete biosynthetic pathway has been elucidated. It has been demonstrated that novel polyene macrolide analogues can be produced through manipulation of the biosynthetic genes. The gene cluster has been licensed by Biosergen and used, in combination with chemical modifications, to generate a series of new analogues, which have been systematically tested in vitro and in vivo.

The most promising candidates have been subjected to a comprehensive test program, which included toxicity, efficacy and pharmacokinetics studies. One of these analogues was shown in the in vivo experiments to have properties superior to those of the conventional amphotericin B in terms of toxicity, activity, pharmacokinetics and administration.

This analogue has been selected as a CD (BSG005G), which will be further evaluated through regulatory preclinical and clinical tests. The objective is to obtain proof of concept through the completion of clinical phase II trials during 2012.

Fungual Infections

Fungal infections represent a growing problem due to the rapidly increasing number of patients with their immune systems compromised because of an HIV infection, certain types of anticancer chemotherapy, or administration of immunosuppressive drugs after organ transplantation. Weakened immune system makes this group of patients especially prone to life-threatening invasive mycoses usually caused by Candida, Cryptococcus, and Aspergillus. The choice of efficient antifungal agents capable of dealing with this problem is quite limited, and currently used drugs often cause serious side-effects and are difficult to administer. In addition, fungal pathogens relatively quickly develop resistance to some of the antifungals in use today. According to the Antifungal Work Group at NIH, there is a "critical need for the development of antifungal agents".