FDA approved ALM201 for ovarian cancer

Ovarian cancer is caused by one kind of malignant tumor of ovarian neoplasms, which refers to malignant tumor cells surviving on women’s ovaries. 90%~95% of those tumor cells induce primary ovarian cancer, and the rest are cancer cells transmitted from other body parts. The early diagnosis of ovarian cancer is relatively difficult due to the lack of peculiar symptoms in the early stage and the cancer screening tests are functionally limited. Once diagnosed, 60%~70% of ovarian cancers are already terminal plus the corresponding therapy is usually ineffective. Therefore, the morbidity of ovarian cancer is lower than cervical cancer and endometrial cancer and ranks three, but its mortality, however, surpasses the sum of the other two cancers, remarkably ranking top among gynecological cancers as the biggest potential threat to women’s health. In addition, in many countries ovarian cancer ranks top ten in diagnosis and top five in mortality in different cancers. There are approximately 80% ovarian cancer patients with terminal symptoms. All in all, the multiple cancer molecular targeting therapy is rather important to ovarian cancer patients.

Recently, a British biopharmaceutical company Almac Discovery announced that it has been granted by the FDA the privilege of treating orphans suffering ovarian cancer with testing medicine ALM201. Almac Discovery is a British biopharmaceutic company, headquartered in Northern Ireland, focusing on discovery and identification of innovative therapy methods to cure cancer. In America, rare diseases refer to the disease types whose sufferers number less 200 thousand. The incentive measures on drug research and development of rare diseases include various clinical development measures, such as related tax credit in clinical trial expenditure, reduction of FDA user fees, FDA assistance in clinical trial designs, and 7 year monopoly on the market after drugs are approved.

ALM201 is a first-in-class type of remedial polypeptide, developed to simulate some properties of one kind of protein spontaneously produced in bodies. The development of it was initially based on professor Tracy Robson’s research, which shows that FKBPL is naturally secreted protein enabling to impact several important biological processes of tumor, including cancer stem cells and angiogenesis.

In the vitro and vivo researches, ALM201 manifests extremely powerful anti-angiogenic activity which restrains the removal, tubule formation and capillary formation; while in the model of mice transplanted tumor, ALM201 was proofed to be very effective in the condition of low dose and with no influence of cell proliferation.