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New Drug CF-102 for Liver Cancer Enters Phase 1 Clinical Trials
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October 21, 2007
Press release
Can-Fite: CF102 Drug is Effective in Promoting Liver Tissue Regeneration; Clinical Trials with CF102 in the Treatment of Liver Cancer are Due to Commence in Early 2008
Can-Fite filed a patent on the use of the drug to promote liver tissue regeneration; this is in addition to the original indication in the treatment of liver cancer and viral hepatitis
Can-Fite BioPharma Ltd. announced today that its CF102 drug, which is being developed for the treatment of viral hepatitis and liver cancer, was tested in preclinical trials and shown to be effective in promoting liver tissue regeneration following partial hepatectomy. The Company filed a patent application on this innovative findings and will include this indication in further clinical development of CF102.
Partial hepatectomy is usually performed in patients with primary or metastatic liver cancer. Rapid liver regeneration is crucial in these conditions and determines future liver function and chances for successful recovery. Regeneration of normal liver tissue is also needed to preserve liver function in patients with liver failure. No drugs are currently available to speed up the regeneration process; therefore, developing a drug for the treatment of patients undergoing hepatectomy or patients with liver failure is at need.
Similar to CF101, Can-Fite's first drug which is currently in Phase IIb Clinical studies, CF102 specifically attacks liver tumors and hepatitis infected cells. The novel indication for regeneration of normal liver tissue extends the use of CF102 to include treatment of patients undergoing partial hepatectomy and patients suffering from diseases leading to liver failure.
Can-Fite also announced that preparation is currently underway for a phase I trial with CF102, which is due to commence in the US in the first quarter of 2008. This trial in healthy volunteers will allow the Company to push the drug into advanced phases for the abovementioned indications, including liver cancer, hepatitis and the novel application of rapid liver regeneration.
Prof. Ran Tur-Kaspa, a world wide expert in liver diseases from Rabin Medical Center, said that "Treatment with CF102, which binds specifically to the A3 Adenosine Receptor, marks a breakthrough in the development of liver regeneration agents. The profile of this drug, which has several applications in the field of liver diseases, is unique and should provide a solution for patients with these debilitating conditions."
Can-Fite estimates that the market for drugs that promote liver regeneration mostly derived from patients with hepatitis B and C. Out of 130 million patients with hepatitis C and 350 million patients with hepatitis B, 100 million patients are at high risk for developing liver failure or liver cancer, and may need drugs that speed up the regeneration of their infected liver during the course of disease.
Can-Fite Develops a Blood Test to Predict Patientsf Response to the Company Drugs
The test measures blood levels of the A3 adenosine receptor, the target attacked by Can-Fite's drugs; the test will predict patientfs response to
treatment
The Company has applied for a patent to protect this technology Can-Fite BioPharma Ltd. completed the development of a blood test that determines the mRNA expression levels of the A3 adenosine receptor. The latter is a G protein cell surface receptor, highly expressed in inflammatory and cancer cells and has low expression in normal cells. The Company drugs target with high affinity and selectivity this cell surface receptor.
The blood test, which was developed by Can-Fite scientists, requires minute blood quantities and can be analyzed by qualified labs. Company scientists have also found that the blood levels of this receptor reflect its status in the remote pathological organ. The Company has applied for a patent to protect its newly developed blood test.
Previous clinical trials conducted by the Company in Rheumatoid Arthritis patients have shown statistically significant correlation between receptor levels at base line and patientsf response to CF101, the company lead drug candidate. These results indicate that the blood test predicts patientfs response to the drug prior to treatment initiation. A manuscript summarizing these data was recently accepted for publication by Journal of Rheumatology and will be published shortly.
Prof. Pnina Fishman, CEO of Can-Fite, said today that "the simple and rapid blood test would allow the Company to test for the presence of the target during advanced international clinical trials and this would confirm that the test is capable of predicting treatment response. In the next step the Company will consider issuing a marketing license for this test, which will utilize the A3 adenosine receptor as a biological marker to predict patient response to the drug.
Can-Fite recently reported the completion of preclinical trials in the US with CF102, the Company's second molecule in development, for the treatment of liver cancer and hepatitis. The Company estimates that CF102 will enter clinical trials shortly.
Can-Fite Biopharma Ltd is a public company traded on the Tel-Aviv Stock
Exchange. The Company, which commenced business activity in 2000, was founded by researcher Prof. Pnina Fishman and patent attorney Dr. Ilan Cohn. The Company focuses on the development of small molecule-based drugs which target the A3 adenosine receptor and inhibit the development of cancer or inflammatory cells. The market for the company's drugs is estimated at billions of dollars.
For details: Amir Eisenberg, 0528-260285; Shai Eliash 0522-546635; Liron
Singer 0525-476661; Inbal Levi 0524-022274; Miri Riley 0524-022275; Office 03-
7538828
Can-Fite Successfully Completes Preclinical Trials with its second
Drug Candidate CF102
Soon to submit to the FDA an application for a phase I clinical trial
The drug is indicated for the treatment of patients with liver cancer and
patients infected with Hepatitis; current market share for these clinical
applications is estimated at approximately USD 3.5 billion
Prof. Pnina Fishman, CEO of Can-Fite: "We are very pleased with the rapid
progress in the development of CF102 and with the impressive results obtained in the preclinical studies, which will enable the Company to proceed into human clinical trials within several months. CF102 enriches Can Fitefs portfolio beyond CF101, which is being developed for three indications: rheumatoid arthritis, psoriasis and dry eye syndrome."
Can-Fite BioPharma Ltd., a biotechnology company traded on the Tel Aviv
Stock Exchange, announced today the successful completion of preclinical trials
with CF102, the second molecule in the Companyfs development pipeline, which is the basis for a drug indicated for the treatment of liver cancer and hepatitis. Success of the preclinical trials will enable Can-Fite to submit to the US Food and Drug Administration (FDA) an application for phase I human clinical trials.
The Company estimates that the clinical phase of the trials will begin in the up-coming months. Can-Fite VP Drug Development Dr. William Kerns: " CF102 has been evaluated in an IND enabling pharmacokinetic, metabolism, toxicology and safety pharmacology program in the US and Europe. Theses preclinical studies progressed smoothly and no issues that could adversely affect the clinical development program were identified. In particular, CF102 has been shown in these pre-clinical studies to be safe. CF102 is thus positioned to move forward to Phase 1 clinical trials. The company plans to file an IND and commence Phase 1 during the next couple of months", stated Dr William Kerns, VP Development for Can-Fite.
With the initiation of the CF102 clinical trial, Can-Fite will have two pipeline drugs in humans for diverse indications including cancer, autoimmune inflammatory disease and viral diseases.
CF102 binds with high selectivity and specificity to the A3 Adenosine Receptor, which is over-expressed on the cell surface of liver cancer cells. Laboratory studies have shown that CF102 induces apoptosis of liver cancer cells. Liver cancer affects about 450,000 new patients each year and is highly prevalent in people infected with hepatitis virus and in alcohol abusers. This type of cancer is particularly common in Eastern countries, due to the high proportion of people infected with the hepatitis virus. The current market share for liver cancer is estimated at about USD 0.5 billion due to lack of appropriate treatment.
CF102 belongs to a chemical class of substances called nucleosides, known to act as antiviral agents. Laboratory studies conducted by the Company in collaboration with a leading laboratory at Temple University in Philadelphia show that CF102 is also active against the hepatitis virus. The number of individuals infected with hepatitis B and C worldwide is 350 million and 170 million, respectively, and these numbers are rapidly increasing in recent years. The market share is currently about USD 3 billion annually due to lack of appropriate treatments.
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