MATEON THERAPEUTICS, INC. (OTCMKTS:MATN) Files An 8-K Other Events
Item 8.01 Other Events.
On May 5, 2020, Mateon Therapeutics, Inc. (the “Company”) issued a press release announcing that the US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug for a “rare pediatric disease”.
Preclinical studies in which CA4P was combined with an anti-CTLA4 antibody using an EMT-6 mammary tumor model showed that 7 out of 8 mice receiving a combination of CA4P and an anti-CTLA4 antibody experienced complete remission of their tumors, compared to only 1 of 8 in the CA4P monotherapy arm and 2 of 8 in the anti-CTLA4 antibody monotherapy.
CA4P as single agent resulted in 2 Stable Disease (SD) of 5 melanoma patients who failed standard therapies. CA4P combination with carboplatin and paclitaxel resulted in one Partial Response (PR) of 6 melanoma patients who failed first-line therapy with dacarbazine and sorafenib.
A copy of that press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Forward-Looking Statements
This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this communication, the words “will,” “may,” “would,” “approximate,” “expect,” “intend,” and similar expressions and their variants may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements relating to the anticipated timing or results of the Company’s planned phase 3 trial for the OT101 product candidate, the Company’s ability to successfully secure any U.S. FDA priority review voucher, or the Company’s ability to sell and U.S. FDA priority review voucher or the terms of any such potential sale. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors that could cause actual events to differ from expectations, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Press Release | Filed herewith |
MATEON THERAPEUTICS INC Exhibit
EX-99.1 2 ex99-1.htm Exhibit 99.1 FDA GRANTS PEDIATRIC DISEASE DESIGNATION FOR MATEON’S CA4P Treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients AGOURA HILLS,…
To view the full exhibit click here
About MATEON THERAPEUTICS, INC. (OTCMKTS:MATN)
Mateon Therapeutics, Inc., formerly OXiGENE, Inc., is a biopharmaceutical company. The Company is focused on the development of vascular disrupting agents (VDAs) for the treatment of cancer. The Company is engaged in developing two clinical stage investigational drugs: VDAs-CA4P and OXi4503. Its lead compound is CA4P, which is also known as combretastatin A4-phosphate, fosbretabulin tromethamine, fosbretabulin and ZYBRESTAT. VDAs selectively targets the vasculature of cancer tumors and obstructs a tumor’s blood supply without disrupting the blood supply to normal tissues. VDAs are in a class of drugs called vascular targeted therapies (VTTs), which also includes anti-angiogenic agents (AAs). CA4P is a reversible tubulin binding agent that selectively targets the endothelial cells that make up the blood vessel walls in solid tumors. The Company is pursuing the development of a product candidate, OXi4503, which is a dual-mechanism VDA.
