FDA accepts IND for cancer mAbs
accepted its New Drug Application for a humanised monoclonal
antibody, intended for the treatment of advanced ovarian cancer.
According to the American Cancer Society, ovarian cancer ranks fourth in cancer deaths among women, accounting for more deaths than any other cancer of the reproductive system. In 2005, it is estimated that there will be 22,220 new cases of ovarian cancer in the US and approximately 16,000 women will die from the disease. Figures from the World Health Organisation estimate that worldwide, more than 182,000 new patients will be diagnosed with this form of cancer.
The Phase I clinical study is designed as an open label single dose escalation safety study in patients with chemo-refractive ovarian cancer. Morphotek's monoclonal antibody (mAbs), MORAb-003, is Morphotek's lead product directed against a cell surface glycoprotein tumour target. This target is over expressed on the cell surface of a variety of cancer types, with particularly robust overexpression in ovarian tumours.
In pre-clinical cancer models the antibody demonstrated it can efficiently kill chemo-refractory tumours and suppress growth in xenograft studies.
Currently the limited efficacy of conventional therapies combined with serious side effects, has increased demand for monoclonal (mAbs), market success will depend on clearly establishing their clinical and cost benefits.
The improved side effect profile of mAbs is a significant advantage and offers the patient a well-tolerated therapy while also lowering overall disease management costs. They have also provided significant benefits in terms of extending the survival rate of terminally ill patients.
In contrast, small molecule drugs have been liable to producing undesired side effects that extract heavy costs in terms of both patient health and financial spending. Nowhere is this truer than in the treatment of cancer, which historically has been characterised by the use of nonspecific cytotoxic agents and radiation.
According to >Morphotek, ovarian cancer is a growing market where the combined sales of three commonly prescribed drugs accounted for more than $2 billion (€1.5 billion) in the year 2000.
"An unmet medical need exists for patients with advanced, chemo-refractory ovarian cancer," stated Nicholas Nicolaides, president and chief executive officer.
"In pre-clinical studies MORAb-003 has been shown to be active against chemo-refractory ovarian tumours. The antibody targets a receptor present at high density on cancer cells, and offers a very high degree of specificity for malignant tissues."
Frost and Sullivan have estimated that the European monoclonal antibody therapeutics market is set to grow at a compound annual growth rate (CAGR) of 34.1 per cent to $11.4 billion (€8.7 billion) by 2011.
The market researchers identified oncology and autoimmune and inflammatory disorders (AIID) as the primary areas of commercial prosperity. Oncology is likely to remain the leading revenue generator with sales of approximately $6.5 billion forecast in 2011.
There are currently ten mabs products in Europe commercially available that target specific cancers. These include Remicade (Infliximab), Zevalin (Ibritumomab Tiuxetan), Campath (Alemtuzumab), Herceptin (Trastuzumab), Rituxan (rituximab), Simulect (basiliximab), Zenapax (daclizumab), Synagis (Palivizumab), ReoPro (Abciximab), and the fully human mAb Humira (Adalimumab). While chimeric mAbs currently control the market, humanised and human mAbs are expected to dominate in future.
