SPPI is up more than 6% in the last week alone, as investors' interests grew ahead of Spectrum's scheduled PDUFA date, Apr. 29, 2011.
Meanwhile, corresponding to the rising share price, May $9 call options have seen even larger gains (up ~43% since last week: $.70 --> $1).
This is not the first time Spectrum has tried getting Fusilev approved for advance colorectal cancer. Read more - http://michaeljuan.blogspot.com/2011/04/spectrum-pharmaceuticals-sppi-another.html
About Fusilev
What is FUSILEV (levoleucovorin) for injection?
FUSILEV (levoleucovorin) for injection is a folate analog. FUSILEV is the pharmacologically active isomer of leucovorin (also called folinic acid), which is made up of a mixture of two isomers, one active, and one inactive. FUSILEV can only be administered by your healthcare provider.
How is FUSILEV different?
FUSILEV contains the active isomer of leucovorin and does not contain the inactive isomer of leucovorin. Only one-half of the dose of FUSILEV needs to be given as compared with folinic acid.
What do folates do?
Folates are a group of vitamins that allow cells to reproduce. Specifically, they fuel the synthesis of purinic and pyrimidinic bases, the building blocks of DNA. Cells need to duplicate their own DNA before they can divide. Folate deficiency hinders DNA synthesis and cell division, most notably affecting rapidly proliferating tissues, such as normal bone marrow and cancer tissue.
Folates are a group of vitamins that allow cells to reproduce. Specifically, they fuel the synthesis of purinic and pyrimidinic bases, the building blocks of DNA. Cells need to duplicate their own DNA before they can divide. Folate deficiency hinders DNA synthesis and cell division, most notably affecting rapidly proliferating tissues, such as normal bone marrow and cancer tissue.
The folate form most commonly found in nature, folic acid, has to be metabolized to the reduced active form, in order to exert its biologic activity. FUSILEV is a reduced, active folate.
Why is FUSILEV important to patients?
FUSILEV protects against the toxic effects of methotrexate, which is a type of chemotherapy that prevents folates from being metabolized to the reduced active form , therefore leading to cell death. Specifically, methotrexate is a folic acid antagonist which binds and inhibits one enzyme involved in an early step of the activation of folic acid to folinic acid. The administration of FUSILEV, therefore, bypasses the metabolic block effected by methotrexate.
What is FUSILEV approved for?
Rescue after high-dose methotrexate therapy in osteosarcoma—FUSILEV is used in patients with osteosarcoma who are treated with the folic acid antagonist methotrexate. This drug blocks the replication (copying) of DNA by preventing the active form of folate from being formed. Along with many types of cancer cells, some healthy cells like bone marrow and gastrointestinal mucosa cells also reproduce rapidly, which is why chemotherapy can have toxic effects. FUSILEV rescue therapy allows for a plan of administering a high dose of methotrexate in an attempt to kill more cancer cells while protecting the healthy cells with FUSILEV. This use of FUSILEV is described as rescue therapy.
To reduce the toxicity of methotrexate—FUSILEV is also used to diminish the toxicity of methotrexate in situations where the body is not able to rid itself of the drug normally. FUSILEV is also indicated for accidental overdosage of folic acid antagonists.
Why is FUSILEV important to patients?
FUSILEV protects against the toxic effects of methotrexate, which is a type of chemotherapy that prevents folates from being metabolized to the reduced active form , therefore leading to cell death. Specifically, methotrexate is a folic acid antagonist which binds and inhibits one enzyme involved in an early step of the activation of folic acid to folinic acid. The administration of FUSILEV, therefore, bypasses the metabolic block effected by methotrexate.
What is FUSILEV approved for?
Rescue after high-dose methotrexate therapy in osteosarcoma—FUSILEV is used in patients with osteosarcoma who are treated with the folic acid antagonist methotrexate. This drug blocks the replication (copying) of DNA by preventing the active form of folate from being formed. Along with many types of cancer cells, some healthy cells like bone marrow and gastrointestinal mucosa cells also reproduce rapidly, which is why chemotherapy can have toxic effects. FUSILEV rescue therapy allows for a plan of administering a high dose of methotrexate in an attempt to kill more cancer cells while protecting the healthy cells with FUSILEV. This use of FUSILEV is described as rescue therapy.
To reduce the toxicity of methotrexate—FUSILEV is also used to diminish the toxicity of methotrexate in situations where the body is not able to rid itself of the drug normally. FUSILEV is also indicated for accidental overdosage of folic acid antagonists.
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