US FDA grants Progen's in-house manufacturing of PI-88

Australian biotechnology firm Progen Industries has been notified by the US Food and Drug Administration that the chemistry manufacturing and control section of its New Drug Application for the anticancer agent PI-88 is sufficient to allow the initiation of Phase III clinical trials. The firm added that the the FDA's decision follows their meeting held on October 24, and will allow the in-house manufacturing of the compound, saving approximately A$7.8 million ($10.3 million) of out-sourcing fees to a contract manufacturing organization. The Brisbane-headquartered firm added that the drug has received FDA Orphan Drug designation for use in the treatment of hepatocellular carcinoma (liver cancer), prostate cancer, multiple myeloma and melanoma.