FDA以孤兒藥方式核准胰臟癌疫苗


  【24drs.com】March 18, 2010 — 美國食品藥物管理局(FDA)以孤兒藥方式核准胰臟癌的一種治療型疫苗(商品名GVAX,BioSante Pharmaceuticals公司)。
  
  胰臟癌早期症狀不明顯或症狀前後不一,通常在末期才被診斷出來,存活中位數一般為3-6個月,由於預後如此不佳,極需新的有效治療。
  
  胰臟癌疫苗包括了以基因工程製造、用以產生顆粒性白血球及巨噬細胞株-刺激因子的腫瘤細胞,這是在誘發全身免疫反應中扮演重要角色之抗原呈現細胞的必要生長與活化因子。
  
  分泌顆粒性白血球及巨噬細胞株-刺激因子將可刺激病患的免疫系統,對抗疫苗中的細胞,相似的抗原將可促使對抗原本之癌症的活性。
  
  疫苗腫瘤細胞的致命輻射可防止細胞分化與癌症擴散。
  
  根據藥廠新聞稿,在約翰霍普金斯Sidney Kimmel綜合癌症中心進行中的試驗,正評估將胰臟癌疫苗加入到其他抗癌藥物之單方或複方時的安全性與效果。
  
  GVAX疫苗的其他可能適應症包括白血病與乳癌。

FDA Approves Orphan Drug Status for Pancreatic Cancer Vaccine

By Yael Waknine
Medscape Medical News

March 18, 2010 — The US Food and Drug Administration (FDA) has approved orphan drug status for a therapeutic vaccine (GVAX, BioSante Pharmaceuticals, Inc) to treat pancreatic cancer.

Pancreatic cancer is often diagnosed at a late stage because of lack or inconsistency of symptoms, and median survival generally ranges from 3 to 6 months. Because of this poor prognosis, new and effective treatments are urgently needed.

The pancreatic cancer vaccine is composed of tumor cells that are genetically engineered to produce granulocyte macrophage colony-stimulating factor, which is a crucial growth and activation factor for antigen-presenting cells that play a vital role in the initiation of systemic immune response.

Secretion of granulocyte macrophage colony-stimulating factor therefore stimulates the patient's immune system against the vaccine's cells, and antigen similarity encourages activity against the original cancer.

Lethal irradiation of the vaccine tumor cells precludes cell division and cancer spreading.

According to a company news release, ongoing trials at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, are evaluating the safety and benefit of adding pancreatic cancer vaccine to other anticancer agents alone or with other drugs.

Other potential indications for GVAX vaccines include leukemia and breast cancer.

    
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