Novel Gene Therapy Treatment for Head and Neck Cancer with Impressive Phase III Results in China

Sage's very exciting Chinese client, Guangzhou Doublle Bio-Product Co., Ltd., will report the results of its Chinese Phase 3 study of its Adenolysin, a biological for the treatment of late-stage head neck not including nasopharyngeal cancer, by the end of this year.

Guangzhou Doublle seeks a development and commercialization partner for global or regional rights to Adenolysin outside China.

In the late 1990s as a result of work done by Judah Folkman at the Sydney Farber Institute, endostatin, delivered systemically, was highly regarded as a potential anti-angiogenesis, anti-cancer drug. The Folkman Laboratory showed that insoluble endostatin suppressed VEGF-stimulated endothelial cell proliferation, migration, and tumor angiogenesis. But studies in the early 2000’s showed minimal effect when endostatin was used as a single agent. However, Guangzhou Doublle has shown that endostatin is highly effective when delivered continuously (Adenolysin) in combination with other anti-cancer drugs. Guangzhou Doublle is not aware of any other company conducting studies using endostatin in conjunction with other drugs.

Adenolysin is a type 5 recombinant replication-deficient adenovirus vector carrying the human endostatin gene and it directly introduces the gene into tumors where it continuously expresses the endogenous endostatin to limit vascularization in the tumor. This achieves higher bioavailability for longer periods of time and when combined with chemotherapy significantly improves efficacy with no significant side effects. The company believes that Adenolysin can achieve similar, if not better, results when combined with other classes of anticancer drugs.

Guangzhou Doublle is completing its Phase III study in China at 20 centers with over 200 patients comparing chemotherapy alone (paclitaxel and cisplatin as the control) with chemotherapy plus Adenolysin as the active. An interim Phase III analysis of 103 patients (76 active/27 control) shows Adenolysin achieved a statistically significant Overall Survival of p=0.043 in patients with multiple lesions and p=0.036 in patients with single lesions.

In a Phase II study of Adenolysin with chemotherapy (active) vs chemotherapy alone, Adenolysin achieved a target disease control rate of 89.7%, and the overall disease control rate was 81.0% while the overall disease rate in the control group was 65.6% p<0.05. This study also yielded a statistically significant difference between the active and control groups with respect to TTP of 6.28 months vs 3.38 months with a median PFS of 7.03 months vs 3.60 months. (P = 0.006)

Guangzhou Doublle believes similar results and be achieved in the treatment of other tumor types: hepatocellular carcinoma, lung cancer, prostate cancer, stomach cancer.

Guangzhou Doublle operates a GMP manufacturing facility which is ICH, EMA, FDA regulation compliant. Guangzhou Doublle has an issued patent in China and is working to expand its IP portfolio while also anticipating biologics data exclusivity worldwide.

The Sage Group is seeking partners for ex-China rights for Adenolysin and would be pleased to discuss this with interested parties and send a non-confidential information package.

DR. BILL MASON Director, Sage Group wtm@sagehealthcare.com +44 7785 950134

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