瑞典的一家生物制药公司Diamyd研制的针对1型糖尿病的疫苗已进入Ⅲ期临床试验,已得到荷兰、英国、芬兰、斯洛文尼亚、西班牙和瑞典等六个国家有关监管机构的批准。 发病不超过3个月的1型糖尿病患者应用Diamyd,可保护残存的胰岛β细胞免遭破坏,如果能抢在临床发病前使用,则可防止1型糖尿病发生。胰岛β细胞遭受破坏到一定程度,身体就需要终生依赖胰岛素治疗。 对于1型糖尿病高危人群,这是一个好消息。正在全世界筛查易发1型糖尿病的儿童,这些儿童将从Diamyd获益。 谷氨酸脱羧酶(GAD)抗体阳性的2型糖尿病患者也可应用Diamyd,可延缓或避免胰岛素治疗。大约10%的2型糖尿病患者GAD抗体阳性。 所以,Diamyd,可防治1型糖尿病和使得自身免疫型2型糖尿病患者不需要胰岛素治疗。 As reported in New England Journal of Medicine (Oct 30, 2008), Diamyd preserves insulin producing beta cells best in patients recently diagnosed with the disease. Beta cell destruction is a consecutive process, eventually leading to the need for life-long treatment with insulin. Diamyd given before clinical presentation could hence prevent the onset of the disease.
"This is good news for individuals at risk for type 1 diabetes", says Elisabeth Lindner, President and CEO of Diamyd Medical. Several large programs are in full operation around the world with the goal to screen thousands of small children for their risk to develop type 1 diabetes. These children could all benefit from vaccination with Diamyd.
Beyond the vaccine application for type 1 diabetes, Diamyd has shown effect in preventing insulin treatment in a study including GAD antibody positive patients with type 2 diabetes, representing 10% of all type 2 diabetes patients. The data were recently presented by Professor Carl-David Agardh, Lund University, Sweden.
The three applications; treatment and prevention of type 1 diabetes, as well as prevention of insulin treatment in autoimmune type 2 diabetes, are all believed to have blockbuster potential.
About Diamyd Medical: Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company‘s most advanced project is the GAD-based drug Diamyd for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS).
The company has also out-licensed the use of GAD for the treatment of Parkinson‘s disease. Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). |