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Epizyme Announces Publication of Preclinical Data Demonstrating Clinical Candidate EPZ-6438 as Potent and Selective Inhibitor of EZH2 in Genetically Defined Non-Hodgkin Lymphoma

On February 21, 2014 Epizyme reported the publication of data from preclinical studies of the company’s clinical candidate EPZ-6438 (E7438), a potent and selective small-molecule inhibitor of EZH2, a histone methyltransferase (HMT). Oncogenic mutations in EZH2 occur in a subset of patients with non-Hodgkin lymphoma (NHL), implicating EZH2 as a therapeutic target in these patients (Press release Epizyme, FEB 21, 2014, View Source [SID:1234500113]). This research, published online and in the April issue of the journal Molecular Cancer Therapeutics, provides a preclinical description of EPZ-6438, which Epizyme is developing in partnership with Eisai for the treatment of EZH2 mutant-bearing NHL. The paper expands on data reported by the same authors in a poster presentation at the December 2012 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

"This paper provides a comprehensive description of the preclinical characterization of EPZ-6438 that paved the way for this drug to enter human clinical trials in 2013," said Robert A. Copeland, Ph.D., executive vice president and chief scientific officer, Epizyme. "It is the first and only EZH2 inhibitor in clinical development to our knowledge. The work is illustrative of the ongoing discovery efforts at Epizyme that are fueling the clinical development of multiple drugs against the HMT target class."

Key results published in Molecular Cancer Therapeutics include:
* Detailed characterization of the correlation between EZH2 inhibition, methylation of the EZH2 target (H3K27), reversal of lymphomagenic gene expression and antiproliferative effects specific to EZH2 mutant-bearing NHL cell lines.
* Sustained tumor growth inhibition in animal models of EZH2 mutant-bearing NHL, including durable effects after drug dosing is discontinued.
* Development of an assay to assess methylation of H3K27 in tumor, bone marrow, peripheral blood mononuclear cells and other surrogate tissues.
* Determination of a quantitative PK/PD relationship using this assay.

The paper titled, "Selective Inhibition of EZH2 by EPZ-6438 Leads to Potent Antitumor Activity in EZH2 Mutant Non-Hodgkin Lymphoma," was authored by Sarah Knutson and colleagues at Epizyme and Eisai, and is available online here, View Source

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(Press release, NBE Therapeutics, FEB 21, 2014, View Source;titolo=nbe-therapeutics-announces-validation-of-its-smac-technology-for-adc-development [SID:1234503548])

Novartis shows continued commitment in Japan with Lucentis approval in fourth Japanese indication, diabetic macular edema

pan (2014) as Lucentis has been approved by Japanese regulatory bodies for the treatment of patients with diabetic macular edema (DME) (Press release Novartis, FEB 20, 2014, View Source [SID:1234500112]).
Approval of Lucentis was based on results from the REVEAL trial, the first randomized clinical trial specifically designed to assess the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. In this Phase III trial, 396 patients from six countries, including Japan, were initially treated with monthly injections of 0.5 mg Lucentis, 0.5 mg Lucentis plus laser treatment or laser treatment alone for two months. Treatment was continued for twelve months if stable vision was not reached.
Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians. At twelve months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. Safety results showed that Lucentis was well tolerated in patients with DME both as monotherapy or when administered together with laser.

Cytokinetics Announces Proposed Public Offering of Common Stock

On February 19, 2014 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Cytokinetics, FEB 19, 2014, View Source [SID1234500105]). Cytokinetics also expects to grant the underwriters an option to purchase up to an additional 15% of the shares of common stock offered in the public offering, exercisable for 30 days. All of the shares in the proposed offering are to be sold by Cytokinetics. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cowen and Company, LLC is acting as the sole book-running manager. JMP Securities LLC is acting as a lead manager.

This offering is being made pursuant to an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Cytokinetics has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Cytokinetics and such offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to this offering may be obtained, when available, from Cowen and Company, LLC c/o Broadridge Financial Services., 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: 631-274-2806, Fax: 631-254-7140.

Cytokinetics intends to file a preliminary prospectus supplement relating to the proposed offering with the SEC, which will be available along with the prospectus filed with the SEC in connection with the shelf registration on the SEC’s website at View Source

(Filing, 20-F, Compugen, FEB 18, 2014, View Source [SID:1234503784])

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Category: Uncategorized

Epizyme Announces Publication of Preclinical Data Demonstrating Clinical Candidate EPZ-6438 as Potent and Selective Inhibitor of EZH2 in Genetically Defined Non-Hodgkin Lymphoma

Novartis shows continued commitment in Japan with Lucentis approval in fourth Japanese indication, diabetic macular edema

Cytokinetics Announces Proposed Public Offering of Common Stock