OphthaliX Provides an Update on its Clinical Developments and Strategic Plans

-Glaucoma Phase II ongoing study will enroll patients to the next higher dose without an interim analysis, no safety issues have been recorded

-Based on lack of correlation between target expression and response of patients to the drug, the development of CF101 for Dry Eye Syndrome will be terminated

-The Company is actively evaluating new ophthalmic technologies to enrich its pipeline

Jun 09, 2014, 07:00 ET from OphthaliX Inc.

PETACH TIKVA, Israel, June 9, 2014 /PRNewswire/ -- OphthaliX Inc. (OTCQB: OPLI), announced today an update on its clinical developments and strategic plans:

  • Glaucoma - The Company is focused on the development of CF101 for the treatment of glaucoma, with a Phase II study ongoing in Israel and Europe. The Company intends to amend the ongoing Phase II study protocol and continue to the second cohort, where patients will be treated with 2 mg CF101 or placebo. This decision is based on positive data from the psoriasis Phase II/III study currently conducted with CF101 by Can-Fite BioPharma. As a result, there will not be an interim analysis and the full study data is expected to be announced in mid-2015. If successful, the treatment of glaucoma with an oral drug has the potential to be a breakthrough treatment in resolving patient compliance issues with current topical treatments. A third-party validation for the utilization of A3 adenosine receptor agonists for lowering intraocular pressure and treating glaucoma has been recently published by Professor M. Francesca Cordeiro, a Professor of Glaucoma & Retinal Neuro-degeneration at the University College of London and Imperial College in London.
  • Dry Eye Syndrome - The Company has decided to end the development of CF101 for the dry eye syndrome indication. This decision is based on a lack of correlation between patients' response to CF101 and over-expression of the drug target, the A3 adenosine receptor in this patient population.
  • In-Licensing New Technologies - As part of OphthaliX's corporate strategy to build a specialized ophthalmic company that develops and in-licenses drugs for the treatment of ophthalmic diseases, the Company is currently exploring opportunities to obtain technologies that will complement and expand the existing pipeline.

About OphthaliX Inc.

OphthaliX Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders.

About CF101

CF101, an A3 adenosine receptor (A3AR) agonist, is a novel, first in class small molecule orally bioavailable drug which binds with high affinity and selectivity to the A3AR, which is known to be over-expressed in inflammatory cells. The drug acts as a neuro-protective agent and prevents apoptosis of retinal ganglion cells.

Forward-Looking Statements

This press release contains forward-looking statements, about OphthaliX's expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, OphthaliX or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by OphthaliX with the U.S. Securities and Exchange Commission (the "SEC"), press releases or oral statements made by or with the approval of one of OphthaliX's authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause OphthaliX's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause OphthaliX's actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in OphthaliX's filings with the SEC.  In addition, OphthaliX operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. OphthaliX undertakes no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE OphthaliX Inc.