Each year nearly 20,000 people in the U.S. are diagnosed with primary brain cancers (with a similar number in Europe), according to NCI/NIH statistics, with Schering-Plough's (NYSE:SGP) Temodar (temozolomide or TMZ is classified as a DNA-methylating chemotherapy drug) given to nearly every patient with a diagnosis of GBM (the most common and aggressive form of brain cancer). Newly diagnosed individuals with GBM typically undergo surgery (if possible) to remove the tumor, followed by radiation and chemotherapy with a median survival outcome of about 10-12 months.
Below is a selection of small and micro-cap stocks from my Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index that are involved in research activities to improve the treatment of brain cancer. In addition, three of the companies profiled below are among 10 stocks in the Mentor Capital Cancer Immunotherapy Index (MNTR.pk)
Northwest Biotherapeutics (OTC:NWBO) is developing DCVax-Brain as an experimental autologous (patient-derived) cellular therapy that is designed to create a specific immune response against a patient's cancer. DCVax-Brain utilizes a patient's own dendritic cells (DC), and an extract of the patient's own tumor cells to achieve an immune response.
In early April, Ark Therapeutics (PINK:ARKTF) (LON:AKT) announced the first update of results for its Cerepro Phase 3 clinical trial as a novel gene-based medicine for the treatment of operable malignant glioma. The study is being conducted to confirm the safety and efficacy of Cerepro in patients with operable high grade glioma (brain cancer) against current standard treatment options, including (1) surgery and radiotherapy or (2) surgery and radiotherapy followed approximately 40 days post-op by temozolomide.
Significance levels associated with the main data have improved in the update analyses and 29 patients have yet to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro and 11 received standard of care treatment. Data suggests improved overall survival in patients receiving Cerepro after about 500 days with 56 patients in the trial still alive. A marketing approval application (MAA) in Europe for Cerepro was filed with the EMEA in 4Q08 and an opinion from the CHMP is expected during 4Q09.
Cerepro is a novel gene-based product for the treatment of patients with operable high grade glioma and utilizes a well-established adenoviral vector (Ad5) to introduce the gene that causes cells to express a protein called thymidine kinase ("TK"). Following the standard surgery to remove the solid tumor mass, Cerepro is injected through the wall of the cavity left behind by the surgical removal of the solid tumor, into the surrounding healthy brain tissue. In the following days, the healthy cells in the wall of the cavity express TK.
Five days after surgery, the drug ganciclovir (GCV) is given to the patient as part of the overall Cerepro treatment regimen. Neither TK nor GCV is individually active but they react together to produce a substance which destroys cells when they try to divide. Since cell division is a key characteristic of cancer and the normal brain cells are not dividing, cells that try to divide to form a new tumor around the site of the removal of the original tumor are targeted for destruction by the Cerepro treatment.
Exelixis (NASDAQ:EXEL) is co-developing XL184 (BMS-907351) along with Bristol-Myers (NYSE:BMY). A Phase 2 trial of XL184 in subjects with progressive or recurrent GBM in first or second relapse is ongoing. XL184 inhibits MET, VEGFR2, and RET, which are key drivers of tumor formation, growth, and metastasis. The Company is also co-developing XL765 along with Sanofi-Aventis (NYSE:SNY).
