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news.BioSante Pharmaceuticals has declared positive results of a human clinical study that demonstrate that GVAX Leukemia vaccine may be able to diminish or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients receiving the drug Gleevec (imatinib mesylate).
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All patients enrolled in the trial used Gleevec for a minimum of one year and still had cancer cells present. The study was conducted by researchers at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, led by Hyam Levitsky, professor of oncology, medicine and urology at the Cancer Center. The research was funded by the National Institutes of Health.
In a study published in Clinical Cancer Research, the investigators at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center used a vaccine made from CML cells irradiated to cease their cancerous potential and genetically altered to create an immune system stimulator called GM-CSF. The treated cells also carry molecules, called antigens, specific to CML cells, which prepare the immune system to identify and kill circulating CML cells.
Dr Levitsky said: “We want to get rid of every last cancer cell in the body, and using cancer vaccines may be a good way to mop up residual disease. More research to confirm and expand the results is needed.”
The GVAX Leukemia vaccine was given to 19 CML patients with measurable cancer cells, inspite of taking Gleevec for at least one year (range 13-53 months). Each patient was given a series of four vaccines administered in three-week intervals while remaining were on a stable dose of Gleevec.
After observation for a median of 72 months, the number of remaining cancer cells declined in 13 patients, eight of whom had increasing disease burden before vaccination. Twelve patients reached their lowest levels of residual cancer cells till date following vaccination. In seven patients, CML became completely undetectable.
The company claimed that the patients receiving the GVAX Leukemia vaccine experienced relatively few side effects that included injection site pain and swelling, occasional muscle aches and mild fevers.
Stephen Simes, president and CEO of BioSante, said: “We are very excited by these GVAX Leukemia vaccine data. Johns Hopkins Kimmel Cancer Center work in leukemia using BioSante’s GVAX is one of many different forms of cancer being investigated, including pancreatic cancer, breast cancer and multiple myeloma.
“We look forward to working with Johns Hopkins’s investigators to bring better cancer therapies to patients in need. BioSante owns the commercial rights to all GVAX vaccines as a result of our acquisition in 2009 of Cell Genesys.”
The investigators said that most patients with CML have to remain on Gleevec therapy for the rest of their lives. More than 90% of them will achieve remission, but about 10 to 15% of patients cannot tolerate the drug long term.
According to the company, in 2010, approximately 5,050 new cases will be diagnosed with CML and approximately 470 people will die. The average person’s lifetime risk of getting CML is about 1 in 645. The average age at diagnosis of CML is around 66 years. Over half of cases are diagnosed in people 65 and older. This type of leukemia mainly affects adults, and is rarely seen in children.
BioSante Pharmaceuticals is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. The company’s products include LibiGel (transdermal testosterone gel) in Phase III clinical development by it under a US Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin (estradiol gel) developed through FDA approval by it, intended for the treatment of moderate-to-severe vasomotor symptoms related to menopause.