Galena Biopharma Inc (NASDAQ:GALE) has today released a statement announcing that the FDA (US Food and Drug Administration) has granted a go- ahead for the use of two cancer drug designations. As stated in the press release statement, the two drug designations are meant for the treatment of ovarian cancer as well as its recurrence effects to cancer patients. Gale Inc. was able to derive the two drugs from the Foliate Protein Binding (FBD) that is widely used by medical scientists. The company has further specified that the specific drugs that were allowed for use by the FDA are for GALE-301 (E39 and E39) and GALE-302(E39’).
Through GALE’s initial assays for the drugs, their researchers were able to combine GALE-301 and GALE-302 GM-CSF (Granulocyte macrophage-colony stimulators and immune adjuvant) forming the two new drugs that will profoundly improve the state of ovarian cancer patients not only in the US but globally.
According to Doctor Mark Schwartz, the CEO and President of GALE, over 50% of ovarian cancer cases are likely to recur for the first five years of treatment because the ovarian cancer cells are quite aggressive. It was therefore, the company’s aim to develop drugs that would help lower down the recurrence rate by advancing the FBP immunotherapy programs inclusive of the GALE-301 and GALE-302 in the patient population according to Doctor Schwartz.
GALE researchers have developed a Designation drug program which is meant to test the safety status of the drugs and biologics to enhance safe medicines for cancer patients with minimal side-effects. According to the company, it will be easier to offer effective treatment for patients with special ailments and disorders in the US and the globe at large.
It is through the Orphan designations that the sponsor for various development projects for drugs is approved and granted permission in the USA for the first seven years after the approval of a drug. This system majors on whether the drug developing corporations are tax compliant as well the exemptions available for prescription drug user free.
Through GALE-301 and GALE-302 cancer immunotherapies, cancer patients will no longer have to go through the pain of cancer recurrence even after years of radiotherapy.