11-7-13 9:00 AM EST | Email Article

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that 10 abstracts describing the company's investigational agents for several hematological malignancies have been selected for presentation at the Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10 in New Orleans. The abstracts describe clinical and pre-clinical data from studies of idelalisib, which is currently under review by the U.S. Food and Drug Administration for treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL), as well as for GS-9973, GS-9820 and momelotinib (formerly CYT387 / GS-0387). Detailed results from these studies will be presented at the conference.

“We are encouraged by the data across our hematologic oncology pipeline that will be presented at the ASH annual meeting,” said Roy Baynes, MD, PhD, Senior Vice President of Oncology and Inflammation Therapeutics at Gilead Sciences. “We are moving forward quickly to fully explore the potential clinical benefit of idelalisib and other investigational agents against a range of hematological cancers.”

Presentations on idelalisib, Gilead's investigational, targeted, oral inhibitor of PI3K delta include:

  • Updated data from a Phase 2 study (Study 101-09) in patients with highly refractory iNHL (#85). The results of this trial support Gilead’s regulatory filings for idelalisib for the treatment of iNHL.
  • Analyses from a Phase 1b study (Study 101-07) of idelalisib in combination with currently approved therapies for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) (#4180, #4176 and #2878).
  • An analysis from Phase 1b and 2 studies (Studies 101-07 and 101-08) comparing responses among CLL patients with high risk prognostic markers (Del(17p)/TP53 mutation, Del(11q), IgHV mutation and NOTCH1 mutation) to CLL patients without these markers (#1632).
  • The first pre-clinical data demonstrating the potential of idelalisib for the treatment of myelofibrosis (#4065).

Clinical data on other oral investigational compounds in development for the treatment of hematologic malignancies also will be presented, including:

  • Momelotinib, a selective inhibitor of JAK1 and JAK2: Updated safety and efficacy results from a Phase 1/2 study in myelofibrosis (#108). The Phase 3 clinical program for momelotinib will be initiated this quarter.
  • GS-9973, a selective inhibitor of spleen tyrosine kinase (Syk): Initial results from a Phase 2 study in CLL and non-Hodgkin lymphoma (NHL) (#1634). GS-9973 is being evaluated in Phase 2 studies as both a single agent (Study 102) and in combination with idelalisib (Study 103) in patients with relapsed or refractory CLL, iNHL and other lymphoid malignancies.
  • GS-9820, a second-generation inhibitor of PI3K delta: Data from a Phase 1b dose escalation monotherapy study for recurrent CLL or iNHL (#2881).

Abstracts for Gilead's presentations can be accessed at http://www.hematology.org/Meetings/Annual-Meeting/. Further information about the clinical studies described above can be found at www.clinicaltrials.gov.

Idelalisib, momelotinib, GS-9973 and GS-9820, each as single-agents and in combination with other agents, are investigational products, and their safety and efficacy have not been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from clinical trials involving idelalisib, momelotinib, GS-9973 and GS-9820, as single agents or in combination with other agents. In addition, Gilead may not initiate its Phase 3 clinical program for momelotinib in the currently anticipated timelines. Gilead faces risks related to its ability to enroll patients in future clinical studies for these agents and may need to modify or delay these studies. Further, Gilead may make a strategic decision to discontinue development of idelalisib, momelotinib, GS-9973 and GS-9820 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, idelalisib, momelotinib, GS-9973 and GS-9820 may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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