Biopharmaceutical company, Insmed, are to commence clinical development of a small molecule tyrosine kinase inhibitor, which has demonstrated anti-tumour activity in preclinical studies of breast, lung, pancreatic and prostate tumours.
INSM-18, has demonstrated selective inhibition of the insulin-like factor-I receptor (IGF-1) and human epidermal growth factor receptor, Her2/neu. These results suggest the molecule has enormous potential to eventually treat the 230,000 new cases of prostate cancer that occur every year in the United States.
Additional figures from the American Cancer Society estimate that 30,000 deaths in 2004 will occur as a result of prostate cancer, making it the second leading cause of cancer death in men.
Insmed, which are in collaboration with the University of California (UCSF), are to initiate a dose-escalating clinical study primarily designed to define the maximum tolerated dose of INSM-18 in patients with relapsed prostate cancer.
The study will consist of a 28-day extension at each dose level to investigate the effect of INSM-18 on prostate specific antigen (PSA) levels. PSA is a standard serum marker for prostate cancer progression.
Ira Goldfine, lead investigator of the study said: "INSM-18 is a very interesting molecule that inhibits the IGF-IR tyrosine kinase, activation of which can trigger tumorigenesis."
"The clinical safety of this molecule has already been established. Thus this study should allow us to very quickly determine signs of efficacy of this drug in the treatment of prostate cancer."
Prostate cancer is one of the most common cancers of males and according to the International Association of Cancer Registries (IARC). Around 75 per cent of these cases were in developed countries, where the incidence of prostate cancer is increasing by 10-15 per cent every five years.
Geoffrey Allan, Insmed's CEO, commented: "INSM-18 is a small molecule originally licensed to the company for metabolic indications."
"We are very excited to expand our pipeline with this novel tyrosine kinase inhibitor, utilizing our extensive knowledge in IGF biology and growth factor signalling."
The healthcare costs associated with cancer treatment are enormous. According to market researchers Frost and Sullivan the worldwide value of the cancer drug market in 1998 was $6.8 billion (€5.4 billion). This represents only 3 per cent of the total pharmaceutical market.
Industry experts believe that the cancer drug market will grow substantially over the coming decades and maintain a cumulative annual growth rate of 8 per cent, which will result in a market value of $60 billion by 2030.
The rapid growth of this sector can mainly be attributed to an ageing population, increased exposure to environmental carcinogens, increasing demand for effective and safe therapeutics and the arrival of new high-cost drugs to replace generic chemotherapies.
Several new therapeutic methods are emerging in the field of oncology, particularly for prostate cancer. These include therapeutic vaccines, angiogenesis inhibitors and gene therapies. Existing and emerging therapies suggest that therapeutics involving gene therapies are likely to capture a substantial share of the market.