Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), today announced that it has submitted a clinical study protocol to the United States Food and Drug Administration (“US FDA”) for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma.
AGOURA HILLS, Calif., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, today announced that it has submitted a clinical study protocol to the United States Food and Drug Administration (“US FDA”) for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma.
The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma.
CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including:
• Ovarian cancer - 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy;
• Anaplastic thyroid cancer - 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51);
• Platinum resistant ovarian cancer - 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44);
• Non-small cell lung cancer - 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31).
CA4P was generally well tolerated in these studies, and toxicity did not appear to be significantly related to dose frequency. The Company believes that the combination of CA4P together with checkpoint inhibitors, such as pembrolizumab, could be synergistic. Mechanistically, the trial is also designed to assess the impact of CA4P on tumoral TGF-β signature which would allow us to integrate CA4P into our TGF-β platform as combination with checkpoint inhibitors, CAR-T, and vaccine/oncolytic viruses.
“This is the first of a series of planned clinical trials in melanoma patients to ultimately obtain marketing approval for CA4P in a Rare Pediatric Disease. The US FDA has previously granted the Company a Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients.” noted Dr. Vuong Trieu, Chairman and Chief Executive Office of Oncotelic.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic is an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-β RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. in November 2019.
For more information, please visit www.oncotelic.com
Oncotelic’s Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of 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. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause material differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company’s annual report on Form 10-K filed with the SEC on April 15, 2021 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact Information:
For Oncotelic Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com
