On May 11, 2015 Can-Fite BioPharma reported it recently received clearance from the European Medicines Agency to commence dosing patients in Europe in its global Phase II trial for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Filing, 6-K, Can-Fite BioPharma, MAY 11, 2015, View Source [SID:1234504176]). Shortly after receiving approval, the first patient in Europe was dosed. Schedule your 30 min Free 1stOncology Demo!
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The Phase II randomized, double-blind, placebo controlled trial is being conducted in the U.S., Israel, and Europe. The trial protocol has been approved by regulatory agencies in all three regions and patients have been dosed in Israel and Europe. The study plans to enroll 78 HCC patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.
CF102 has already been granted Orphan Drug Status for the treatment of HCC by the FDA. CF102 is also approved for Compassionate Use by Israel’s Ministry of Health.
"There are no treatment options for patients with advanced liver cancer who have not benefitted from treatment with Nexavar, the only FDA-approved drug on the market for this indication. As patients, who have virtually no other options, are being dosed with CF102, it is certainly our hope that the drug will be of benefit to them," stated Can-Fite CEO Dr. Pnina Fishman.
According to Global Industry Analysts, the global market for liver cancer is projected to exceed $2 billion in 2015. Based on data reported in industry publications, Nexavar annual sales were approximately $1 billion in 2012 and 2013.
About CF102
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
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GP Pharm announces European approval of Lutrate Depot 22.5 mg , a new trimestral Leuprolide depot formulation for the palliative treatment of advanced prostate cancer
On May 8, 2015 GP-Pharm reported that its Lutrate Depot 22.5 mg has been approved through an EU decentralized procedure (Press release, GP Pharm, MAY 8, 2015, View Source [SID1234591045]). Lutrate Depot 22.5 mg is a new trimestral Leuprolide depot formulation for the palliative treatment of advanced prostate cancer.
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Lutrate is based on a by GP-Pharm developed patented technological platform of microspheres.
During its pivotal clinical trial phase III Lutrate Depot 22.5 mg achieved excellent castration levels in patients. Patients with prostate cancer will have the opportunity to benefit from the most effective sustained released formulation.
Lutrate Depot 22.5 mg is expected to become available in Europe during the fourth quarter of 2015.
Lutrate Depot 22.5 mg is the second Leuprolide depot formulation of GP Pharm after the successful registration of Lutrate Depot 3.75 mg in 2010 strengthens its urology and oncology portfolio.
10-Q – Quarterly report [Sections 13 or 15(d)]
Inovio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Inovio, MAY 8, 2015, View Source [SID1234504244]).
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10-Q – Quarterly report [Sections 13 or 15(d)]
Vical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Vical, MAY 8, 2015, View Source [SID1234504175]).
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10-Q – Quarterly report [Sections 13 or 15(d)]
Spectrum Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Spectrum Pharmaceuticals, MAY 8, 2015, View Source [SID1234504173]).
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