Inex is the Canadian biopharmaceutical company which develops and commercializes the proprietary drugs as well as drug delivery systems for progress in the treatment of cancer. Marqibo which is also popularly known as Vincristine Sulphate Liposome’s Injection, is the proprietary medication formulated by using the commonly used off-patent, generic anti-cancer drug called Vincristine which is summarized in the proprietary Sphingosomal drug delivery technology of the company. This novel technology has been designed especially for providing the extended blood circulation, accretion of the tumor as well as extended drug release at the site of the cancer. Such features are aimed to enhance the efficacy and simultaneously minimize the side effects of the summarized drug.

The drug delivery technology of Inex has been exhibited offering the intended, enhanced and maintained delivery of Vincristine to tumor sites. Such combined advantages provide the enhanced bunch of opportunity for Marqibo to kill the cancer cells during mitosis which is considered as too short yet crucial stage for anti-cancer drugs. Marqibo’s crucial stage 2/3 clinical trials on human beings, was concluded in the year 2003 assessing the drug effects on 119 patients with reversed antagonistic non-Hodgkin’s Lymphoma - NHL  which was earlier treated with the combination of two or multiple chemotherapy regimens.

Besides the reversed antagonist NHL, Marqibo is presently being assessed in certain phase 2 clinical trials as the treatment for the first line NHL – in combination therapy, reversed Hodgkin’s disease, relapsed acute Lymphoblastic Leukemia, reversed NHL in combination with the official cancer drug Rituxan – Rituximab, reversed NHL in combination with the accepted cancer drug etoposide.

The non approval letter from the U.S. Food and Drug Administration has provided Inex with guidelines on its next steps towards the official approval. The FDA would like Inex to complete the randomized controlled trials comparing Marqibo with other drugs used for treating the typical types of cancer, in the clinical section; besides encouraging the company’s meeting with the U.S. FDA for discussing the trial designs that would be appropriate for re-applying for the approval.