‘Pulsed’ vitamin D drug could transform advanced prostate cancer treatment
pharmafile | November 9, 2006 | News story | Research and Development |Â Â Â
American biotech company Novacea says it could be on the brink of revolutionising the prostate cancer market if phase III results of its vitamin D pulsed drug live up to expectations.
DN-101 (Asentar) is an intermittent, intensive dose of vitamin D, known as calcitriol. Although there is increasing evidence in the efficacy of combining vitamin D with cancer drugs in the treatment of advanced prostate cancer treatment, high doses of calcitriol can cause excessive amounts of calcium to build up in the blood, as well as creating kidney stones.
Novacea says its innovative pulsed dosing can tackle the serious side effects when prescribed with 'holiday breaks' with one week on treatment and one week off.
Asentar is currently in a phase III clinical trial, the second trial to be conducted by ASCENT (Study of Calcitriol Enhancing Taxotere), which will be completed in the latter part of 2008.
Analysts Cowen & Co have predicted that if results are as good as the first ASCENT trial, the drug could revolutionise the $500 million androgen independent prostate cancer (AIPC) market.
AIPC is a condition where hormonal therapy no longer works for patients with advanced prostate cancer. Each year, more than 30,000 men are diagnosed with the disease in the UK, and Cancer Research UK says the lifetime risk for being diagnosed with prostate cancer is 1 in 14.
Evidence from the first ASCENT trial indicated that Novacea's pulsed dosing of Asentar, in combination with Sanofi-Aventis Taxotere, increased survival rates by nine months, over patients who received Taxotere alone (from an average of 16 and a half months to two and a half years). The combination also reduced serious side effects by 34%.
According to Novacea's chief executive, Brad Goodwin, the use of Taxotere in combination with Asentar in high doses was therapeutically safe when prescribed intermittently.
He told Pharmafocus: "We consider the pulsing procedure as a breakthrough and we are leaders in this field." He added: "We consider pulsed dosing a very feasible regimen."
Eric Schmidt, biotech analyst for Cowen & Co, said:" If the DN-101 plus Taxotere proves more efficacious and better tolerated than the current standard (one week in every three-week period of Taxotere), then Novacea could be in a position to market a potentially revolutionary therapy for AIPC."
He added: "Demonstrations in preclinical and clinical trials have shown that pulsatile administration of high-dose calcitriol could overcome safety concerns while maintaining significant anti-cancer activity."
Mr Goodwin said Novacea had worldwide rights to the formula and were actively looking for funding to market the drug and its pulsing procedure in partnership.
"We are currently engaged in active negotiations with prospective partners both in Europe and America to bring this product to the market," he explained.
Results from the ASCENT-2 trial are expected in late 2008. Novecea hopes to file Asentar in the US by mid-2009 for launch on the market by the end of that year.
Merck is currently developing a new monoclonal antibody, which has shown promise in treating prostate cancer.
