In a July 8 research note, Dawson James Securities analyst Jason Kolbert reported that Can-Fite BioPharma Ltd. (CANF:NYSE.MKT) was green-lighted by the U.S. Food and Drug Administration and the European Medicines Agency to proceed with its proposed pivotal Phase 3 trial of Namodenoson for the treatment of patients with advanced hepatocellular carcinoma with underlying Child-Pugh B7 (CPB7) cirrhosis.
The study will evaluate Namodenoson as a second-line or third-line treatment for CPB7 patients in whom other approved therapies were not or no longer are effective. The purpose of the trial is to support a new drug application for Namodenoson, as well as eventual approval of it.
Total enrollment, to be done at multiple sites globally, is expected to be 450 patients. After 50% of enrolled patients receive treatment, an interim analysis by an independent data monitoring committee will be done.
Kolbert pointed out that an Israeli compassionate use program, in which seven patients were enrolled as of March 2021, is using Namodenoson to treat patients with liver cancer. Also, two patients with advanced liver cancer, in Can-Fite's previous Phase 2 trial, reached an overall survival of four-plus years while being treated with Namodenoson. Thus, they are continuing treatment.
As for the use of Namodenoson in nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), Phase 2 data were positive: 25% of the group treated with 25 milligrams of the drug experienced resolution of their NASH. In comparison, in the placebo group, the number of patients who developed NASH increased 5.9% from none.
"We expect to see progression to a Phase 2b trial with liver biopsy as one of the endpoints," Kolbert commented.
Dawson James has a Buy rating and a $5 per share price target on Can-Fite, the stock of which is trading now at about $2.30 per share.[NLINSERT]
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
Disclosures for Dawson James Securities, Can-Fite BioPharma, July 8, 2021
The Firm does not make a market in the securities of the subject Company (s). The Firm has NOT engaged in investment banking relationships with CANF in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject Company (s). The Firm has received other compensation from the subject Company (s) in the last 12 months for services unrelated to managing or co-managing of a public offering.
Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of February 28, 2021, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.
Analysts receive no direct compensation in connection with the Firm's investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.
Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.