GNI Reports Phase II Results of F647 for Radiation Pneumonitis

GNI Ltd, a clinical-stage biopharmaceutical company in China and Japan, announced on January 23 the results of a Phase II clinical trial of F647 (generic name: pirfenidone) for Radiation Pneumonitis (RP). The results demonstrated a positive trend in efficacy of F647 in reducing the incidence of lung injury of grade II or above induced by radiation therapy. This trial had been conducted in six major cancer centers in China by Shanghai Genomics, Inc., a wholly owned subsidiary of GNI.

The human trial is randomized, double-blind, multi-dose (including placebo), and multi-centered. A total of 107 patients received concurrent or sequential chemotherapy and conformal/intensity -modulated radiation therapy for non-resectable stage nonIII-small cell lung cancer or restricted small cell lung cancer. The total radiation dosage is no less than DT 50 Gy. Patients were randomly assigned to high dose (1,200 mg/day, orally, three times daily) of group (H), low dose (600 mg/day, orally, three times daily) of group (L), and the placebo group (0 mg/day, orally, three times daily) (P) (H: L: P = 35: 36: 36). The first dosage of F647 was given 3 days prior to the beginning of the radiation therapy. The treatment period was 12 weeks and the observation period was 6 months after the completion of radiation therapy.

The key primary end point was the incidence of radiation-induced lung injury with grade II or above (NCI CTC AE v3.0) in the H, L, and P group of patients. The incidences of different group of patients were 20% (H), 27.78% (L), 25% (P) based on full analysis set (FAS). The incidences were 21.43% (H), 30% (L), 31.03% (P) based on per protocol set (PPS). Although there is no statistical significance among the three groups due to the small trial size, it already demonstrated a positive trend of potential efficacy of F647 in preventing the occurrence of severe lung injury induced by radiation therapy. The study also showed that F647 was well tolerated by patients. A much larger human Phase III is being planned to start in mid 2009 to provide further confirmation of safety and efficacy.

Dr. Ying Luo, Chief Executive Officer and Representative Director of GNI, said, "We are very encouraged to see F647's promising effect on preventing radiation-induced lung injury. Nowadays when more and more lung cancer patients are undergoing chemotherapy and radiation therapy, there is an increasing urgency to develop a preventive medicine for this unmet medical need. Facing the current financial market turbulence, the Company's priority is to push its clinical programs forward for early commercialization, while reducing spending on other programs."

In June, 2008, GNI also reported positive Phase II results of F647 in treatment of a rare but fatal disease, Idiopathic Pulmonary Fibrosis (IPF). Following the consultation with the Chinese regulatory agency, SFDA, the Company decided to suspend the preparation of Phase III trial of IPF and seek a fast-track conditional approval for an orphan treatment of IPF (disclosed in September, 2008). The company is currently working with a third party GMP manufacturing and formulation facilities to prepare necessary supporting materials and documents for the NDA filing. The company expects to submit a New Drug Application (NDA) specifically for IPF to SFDA in the fall of 2009.

(Source: Pharma China)