Onconase, manufactured by Alfacell Corporation, is now on the FDA’s Fast Track program. The drug is a stem cell medication that, when used in conjunction with a low-toxicity chemotherapy called doxorubicin, shrinks and kills cancer cells. The Fast Track program enables Alfacell to schedule meetings with the FDA to discuss development plans, submit a New Drug Application in sections rather than all at once, and the ability to request evaluations of surrogate studies.
Alfacell is also developing Onconase clinical trials for non-small cell lung cancer. Though mesothelioma often affects the lungs, it is distinct from other forms of lung cancer because it develops in the mesothelial cells in the linings of the abdomen, lungs, or heart, among other places. The cause of mesothelioma also distinguishes it from other cancers – the inhalation of asbestos fibers accounts for about 80% of diagnoses. Although there is no standardized treatment for mesothelioma, asbestos exposure attorneys are hopeful that this new drug will help extend the lives of mesothelioma victims.
Globally, Alfacell is a leading developer of anti-cancer pharmaceuticals. The Corporation established an International Malignant Mesothelioma Program, which attracted top oncologists and related medical professionals from over 40 regions. During this program, physicians and medical researchers gather to discuss inoperable malignant mesothelioma and Onconase treatment. The purpose of this program is to market the drug to European mesothelioma victims, encouraging them to participate in clinical trials and allowing European oncologists to gain first-hand experience with the drug.
Onconase increases expression of the P16 tumor suppressor genes, which are either non-functional or non-existent in the majority of mesothelioma patients. These genes are responsible for controlling the growth and spread of cancer cells. Interestingly, the drug is developed from the eggs of the leopard frog, from which an enzyme called ribonuclease is extracted. This enzyme damages the RNA in mesothelioma cells; RNA molecules aid in protein synthesis and transmission of genetic information. Thus, the mechanism of Onconase is to damage the basic genetic code of mesothelioma cancer cells so they are unable to grow and spread.
Since the drug is derived from the enzymes of the leopard frog, it is one of the first embryonic stem cell products to reach the final stages of testing. Currently in Phase III trials, reports indicate that 41 to 81% of patients experienced either halting in tumor growth or significant shrinking. In the 300 mesothelioma patients involved in the trial, the median survival was about 18.5 months. The typical survival rate for those with inoperable malignant mesothelioma is between 6 and 9 months. About five years ago, Onconase received orphan drug status from the FDA, which distinguishes pharmaceuticals intended to combat rare diseases. The drug approval process requires hundreds of millions of dollars, and the Orphan Drug Act provides grants for drug companies attempting to treat rare diseases and conditions.
The new drug is intended for use both in combination with doxorubicin,
a chemotherapy drug, and alone, as a second-line mesothelioma treatment.
Second-line treatment is needed in those patients who do not respond to
conventional chemotherapy and radiation. FDA approval of Oncanase will
pave the way for the numerous other drug companies, such as Quintessence,
looking to use RNA-based cancer treatments.
Onconase has also been shown to possess anti-viral activity against HIV-1 virus and effectively fight other types of cancer, including breast cancer and leukemia. Alfacell chose mesothelioma to be the subject of initial trials because of the cancer’s non-responsiveness to traditional cancer treatment. If the drug is approved, and shows significant development in mesothelioma treatment, it will most certainly be used in treatment of other diseases reluctant to traditional treatment.
So far, there have been no toxic deaths associated with the Onconase trials. In Phase II trials, 10 patients out of 105 survived for more than 15 to 55 months, one of whom continued treatment for 3 years and is currently in remission. Mesothelioma attorneys at Pintas & Mullins Law Firm hope that this treatment option will prolong the lives of those affected by asbestos exposure.