Can-Fite to Conduct a Confirmatory Phase IIb Trial in Early 2008 as Part of Ongoing Development of CF101 for the Treatment of Rheumatoid Arthritis
Can-Fite's Clinical Advisory Board has recommended this advanced trial as further evidence for the efficacy observed in a previous trial; this will give green light to the final phase of development Prof. Pnina Fishman, CEO of Can-Fite, said that "the confidence expressed by the Clinical Advisory Board (CAB) members in the CF101 drug, the advantages of the drug over currently available medications and its potential as an antiinflammatory drug, motivates us to proceed vigorously with the development plan for the indication of Rheumatoid Arthritis and for other recently reported indications of CF101 and CF102." Can-Fite BioPharma Ltd. will conduct in early 2008 a confirmatory Phase IIb trial as part of the ongoing development of CF101 for the treatment of Rheumatoid Arthritis (RA). This is in line with recent recommendations made by Can-Fite's CAB which took place in Boston under the chairmanship of Prof. Weinblatt. The CAB recommendations were endorsed last night by Can-Fite's Board of Directors. In July, Can-Fite published the results of a Phase IIb study with CF101 in combination with Methotrexate (MTX) indicating that the ACR20 response, which was the primary efficacy end point of the study, showed no difference between the CF101-treated and placebo groups. However, a substantial difference in favor of CF101 was seen in the ACR50, the ACR70 and the EULAR “Good” response measures. Now, that the CAB has made its recommendations, Can-Fite intends to commence in the first quarter of 2008 an advanced trial similar to the previous one. This trial will include the two dose groups with the best results from the previous trial, in comparison to a control group, and patients will be treated for a period of 12 weeks. The trial will be conducted using a tablet formulation, which was lately developed by the company. Can-Fite estimates that the trial will be initiated at the first quarter of 2008 and may take about 1 year to complete, including data analysis. Can-Fite will soon file an application with the FDA for this trial, which will be conducted under FDA inspection. If the results are favorable, this would mean that Can-Fite has paved the way towards the final phase of drug development. Can-Fite has sufficient financial resources to complete this trial in parallel to other ongoing clinical studies. This progress in the development in CF101 was preceded by recent reports on the successful completion of pre-clinical trials in the US with CF102, Can-Fite's second molecule in the pipeline, which is the foundation of a drug for the treatment of several indications in the Hepatology arena, i.e., hepatocellular carcinoma, hepatitis, liver regeneration. Can-Fite estimates that Phase I clinical trial with CF102 will commence in the coming months.
Are you still watching CanFite Dubi? The stock run from 50 to nearly 140 in less than 2 weeks (today it closed +18%). This came out today but the more important news regarding CF-101 are due soon.
The company intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Can-Fite BioPharma Ltd. (TASE:CFBI) has begun recruiting patients for the Phase I/II clinical trial of CF-102 treatment for liver cancer, after obtaining permission from the Ministry of Health and Rabin Medical Center (Beilinson Hospital) ethics committee.
The clinical trial will examine the safety and effectiveness of CF-102 on 40 patients at the Rabin Medical Center. Patients will receive increasing dosages of the drug during the trial period.
Can-Fite intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Liver cancer is one of the commonest forms of cancer worldwide, striking 450,000 new patients a year. It is especially prevalent among people suffering from hepatitis B and C, and alcoholics.
Can-Fite added that it expects in the coming weeks to announce the results of clinical trials for its drug, CF-101, for the treatment of rheumatoid arthritis and dry-eye syndrome (keratoconjunctivitis sicca). If the trials are successful, the company will begin Phase III trials of the drug for these indications.
Can-Fite's share jumped 11.2% in morning trading to NIS 1.30.
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