0001193125-17-082743.txt : 20170315 0001193125-17-082743.hdr.sgml : 20170315 20170315080055 ACCESSION NUMBER: 0001193125-17-082743 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170315 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170315 DATE AS OF CHANGE: 20170315 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MATEON THERAPEUTICS INC CENTRAL INDEX KEY: 0000908259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133679168 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21990 FILM NUMBER: 17689862 BUSINESS ADDRESS: STREET 1: 701 GATEWAY BLVD. STREET 2: SUITE 210 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-635-7000 MAIL ADDRESS: STREET 1: 701 GATEWAY BLVD. STREET 2: SUITE 210 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: OXIGENE INC DATE OF NAME CHANGE: 19930628 8-K 1 d350105d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): March 15, 2017

 

 

MATEON THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   0-21990   13-3679168

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

701 Gateway Boulevard, Suite 210, South San  
Francisco, CA   94080
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (650) 635-7000

N/A

Former Name or Former Address, if Changed Since Last Report

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01 Other Events.

On March 15, 2017, Mateon Therapeutics, Inc. (“Mateon”) issued a press release announcing initial data from the third dose cohort of its Phase 1b study of OXi4503 in Relapsed/Refractory Acute Myeloid Leukemia. OXi4503 is one of Mateon’s two vascular disrupting agents (VDAs) currently in clinical development.

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

The following exhibit is furnished with this report:

 

Exhibit Number    Description
99.1    Press Release dated March 15, 2017.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Mateon Therapeutics, Inc.
Date: March 15, 2017    

/s/ Matthew M. Loar

    By: Matthew M. Loar
    Chief Financial Officer
EX-99.1 2 d350105dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Mateon Therapeutics Announces Initial Data from

Third Cohort of Phase 1b Study of OXi4503 in Relapsed/Refractory AML

 

    One patient of four (25%) achieved a complete remission

 

    No dose-limiting toxicities observed and study is progressing into the fourth dose cohort

SOUTH SAN FRANCISCO, Calif. – March 15, 2017 – Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced preliminary data from the third dose cohort of the ongoing Phase 1b study OX1222 in patients with relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). OX1222 is a dose-ranging Phase 1b study of OXi4503 combined with cytarabine. The third dose cohort enrolled four patients who received a dose of 6.25 mg/m2 of OXi4503 in combination with an intermediate dose (1g/m2/day x 5 days) of cytarabine.

One patient (25%) in the third dose cohort – who has a high risk TP53 gene mutation – had a complete remission. Two other patients demonstrated evidence of AML blast reduction after one cycle, one of which is receiving additional cycles of OXi4503 plus cytarabine therapy, the other of which has since progressed. The fourth patient did not show a response and experienced progressive disease. There were no dose-limiting toxicities observed in this cohort, and the safety review committee has recommended that we proceed to the fourth cohort, which is now enrolling patients at an OXi4503 dose of 7.81 mg/m2.

“We are excited to continue to see responses in this severe and intractable patient population that currently has few treatment options.” stated William D. Schwieterman, M.D., President and Chief Executive Officer. “We hope the data from this study will continue to improve with higher doses of OXi4503 in subsequent cohorts.”

Results from the first two cohorts of OX1222 were initially presented at the 58th Annual Meeting of the American Society of Hematology (ASH) on December 6, 2016, indicating two out of 10 patients (20%) achieved complete remission. With an additional three months of follow-up data now available on these lower-dose patients in remission (3.75 and 4.68 mg/m2), Mateon is providing updated results – one patient remains in remission nine months following treatment and one patient remained in remission for approximately six months following treatment before the disease recurred.

Similar to the first two cohorts, OXi4503 was generally well tolerated in the third cohort. Adverse events were similar to the first two cohorts, with no significant adverse events in the third cohort.

Mateon reminds investors that a webcast of today’s presentation at the 29th Annual ROTH Conference at 7:30 am pacific time will be available on the company’s website at www.mateon.com in “Events & Presentations” under the “Investors & News” tab. Today’s presentation includes an overview of the mechanism of action of OXi4503 in hematological cancers such as AML and preclinical data from the OXi4503 AML program.


About Mateon

Mateon Therapeutics, Inc. is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy (VTT) in oncology. VTT includes vascular disrupting agents (VDAs) such as the investigational drugs that Mateon is developing, and anti-angiogenic agents (AAs), a number of which are FDA-approved and widely used in cancer treatment. These two approaches have distinct yet complementary mechanisms of action.

At Mateon, we believe that we can significantly improve cancer therapy by employing these two complementary approaches simultaneously. When utilized this way, VDAs obstruct existing blood vessels in the tumor leading to significant central tumor cell death while AAs prevent the formation of new tumor blood vessels.

Mateon is committed to leveraging our intellectual property and the product development expertise of our highly skilled management team to enable VTT to realize its true potential and to bring much-needed new therapies to cancer patients worldwide.

Safe Harbor Statement

Certain statements in this news release, including, but not limited to, those concerning the efficacy of OXi4503 in AML, the potential significance of this data and its relation to other clinical and pre-clinical studies are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. They can be affected by inaccurate assumptions Mateon might make or by known or unknown risks and uncertainties, including, but not limited to: the uncertainties as to the future success of ongoing and planned clinical trials; the unproven safety and efficacy of products under development or that may be developed in the future; and the sufficiency of the Company’s cash resources to conduct and complete future clinical and pre-clinical trials. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Mateon’s reports to the Securities and Exchange Commission, including Mateon’s reports on Forms 10-Q, 8-K and 10-K. However, Mateon undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.

CONTACTS

Investors:

PCG Advisory Group

Stephanie Prince, Managing Director

sprince@pcgadvisory.com

646-762-4518

Media:

JPA Health Communications

Nic DiBella

nic@jpa.com

617-945-5183

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