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ORYZON to Present First Clinical Data from ALICE Phase IIa Trial with Iadademstat at the 24th Congress of the European Hematology Association

Monday, 03 June 2019 08:00 AM

Oryzon Genomics

  • The company will also present at the Jefferies 2019 Global Healthcare Conference

MADRID, SPAIN and CAMBRIDGE, MA / ACCESSWIRE / June 3, 2019 / Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the company will present preliminary safety and efficacy data from one of its ongoing Phase IIa clinical trials with iadademstat, ALICE, at the 24th Congress of the European Hematology Association, EHA-2019, to be held on June 13-16, 2019 in Amsterdam, The Netherlands. The company will present a poster communication entitled "ALICE: An AML study with LSD1 inhibition in combination with Azacitidine in the elderly" on June 14, at 17:30 -19:00 CET.

ALICE ("An AML trial with LSD1i in Combination with azacitidine in the Elderly") is a single arm, open-label Phase IIa clinical trial to evaluate the safety, tolerability, dose finding and efficacy of iadademstat in combination with azacitidine in older patients with Acute Myeloid Leukemia (AML) in first line therapy.

In accordance with the embargo terms and conditions for presentation at the Annual Congress of EHA, data will be released on the same day as the communication, Friday June 14th.

For more info on EHA-2019, please visit: https://ehaweb.org/congress/eha24/key-information/.

On the previous week, Dr. Carlos Buesa, Oryzon's CEO, will present a company overview at the Jefferies 2019 Global Healthcare Conference, to be held at the Grand Hyatt Hotel of New York on June 4-7. Oryzon's presentation will take place on Friday, June 7th at 11:00 am ET, at Ballroom 4. See more info at https://www.jefferies.com/OurFirm/Conferences/325/.

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon's LSD1 program has rendered two compounds vafidemstat and iadademstat in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com.

About Iadademstat

Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (See Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A first Phase I/IIa clinical trial with iadademstat in refractory and relapsed acute leukemia patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), medulloblastoma and others. Oryon is conducting two Phase IIa clinical trials of iadademstat in combination; the first one in combination with azacitidine in elderly AML patients (ALICE study) and the second one in combination with platinum/etoposide in second line SCLC patients (CLEPSIDRA study).

About Vafidemstat

Vafidemstat (ORY-2001) is an oral, brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer's disease, to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Vafidemstat is in Phase IIa clinical studies in patients with Relapse-Remitting and Secondary Progressive MS (SATEEN), in patients with Mild to Moderate Alzheimer's disease (ETHERAL) and in aggressiveness in patients with different psychiatric or neurodegenerative disorders (REIMAGINE, a basket trial).

FORWARD-LOOKING STATEMENTS

This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates" and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish ComisiĆ³n Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon's securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.



US Contact:

Spain:

Oryzon:

Solebury Trout

ATREVIA

Emili Torrell

Thomas Hoffmann

Patricia Cobo/Idoia Revuelta

BD Director

+1 646 378 2931

+34 91 564 07 25

+34 93 515 13 13

[email protected]

[email protected]
[email protected]

[email protected]

SOURCE: Oryzon Genomics

Topic:
Company Update
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