Oncotelic Presents The Synergy Of OT-101 (A Late Stage TGF beta inhibitor) And A Chemotherapy Agent

AGOURA HILLS, Calif., Feb. 9, 2016 /PRNewswire-iReach/ -- Synergistic anti-tumor activity of OT-101, a TGF- 2inhibitor, and Dacarbazine against C8161 human melanoma xenograft in athymic nude mice

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Melanoma is the most aggressive and dangerous form of skin cancer in the United States. Transforming growth factor-beta 2 (TGF-2) expression in malignant melanoma has been implicated in the development of deep invasion and metastases in malignant melanoma. OT-101, also known as Trabedersen, is a single-stranded 18-mer phosphorothioate antisense oligodeoxynucleotide designed to specifically target the human TGF-2 messenger RNA. OT-101 had shown to inhibit the TGF-2 secretion and proliferation of human malignant melanoma cell cultures (Mel-Juso, MER 116, and RPMI 7951) and cell migration from MER 116 spheroids. This study compared the antineoplastic potential of a novel treatment strategy combining OT-101 plus Dacarbazine (DTIC) versus DTIC monotreatment, the current chemotherapeutic mainstay in combating metastatic melanoma. Combining OT-101 and DTIC induced a synergistic effect on tumor inhibition in the C8161 melanoma model. Linear Regression model was created with two independent variables (OT-101 and DTIC) with an interaction variable. An equation was created: Y =1302.23 -30.39 (OT-101) -1018.56 (DTIC) -1197.59(OT-101)*(DTIC). The coefficient of interaction variable has same sign with two independent variable coefficients, which indicates a synergistic interaction effect (p<0.001).   Collectively, these data indicate that OT-101/DTIC combination should be evaluated in clinical trial against melanoma. The clinical data will be reported at future meetings.

Poster Session

Meeting: The 10th Canadian Melanoma Conference, Whistler, British Columbia, Canada

Location: Fairmont Chateau Whistler

Date and Time: February19-20, 2016 9:05-9:20am

Title: " Synergistic anti-tumor activity of OT-101, a TGF- 2 inhibitor, and Dacarbazine against C8161 human melanoma xenograft in athymic nude mice".

Authors: Vuong Trieu*, Li Huang**, Osmond D'Cruz**, and Larn Hwang*

Institutions: ** Autotelic Inc, Fountain Valley, CA, United States  and * Oncotelic Inc. Agoura Hills, CA, United States

About Trabedersen

Trabedersen,  (OT-101) a single-stranded phosphorothioate antisense oligodeoxynucleotide (18-mer)  designed to specifically target the human TGF-2 messenger RNA. The Mechanism of Action  exploration focuses on target downregulation and immunostimulation. Trabedersen is believed to reverse TGF-'s immunosuppressive effects, rendering the tumor visible to a patient's immune system and resulting in priming and specific activation of the patient's anti-tumor immune response. Trabedersen has tested in   Phase l/ll clinical trials against pancreatic cancer and melanoma.  Trabedersen has also been tested in  clinical trials against brain cancer.

About Oncotelic Inc.

Oncotelic's  lead therapeutic platform is OT-101 (Trabedersen).  Oncotelic intends to conduct registration trials for multiple cancer indications including pancreatic, melanoma, and glioblastoma. The executives of Oncotelic are a group of pharmaceutical veterans who believe that Trabedersen will present a paradigm shift in the treatment of cancers.  More information is available at www.oncotelic.com.  

About Autotelic Inc.

Autotelic works through partners to transform how medications are being delivered. The Autotelic Inc. platform is aTherapeutic Drug Monitoring (TDM) device which allows PK guided dosing, reducing the toxicity from overmedication and increasing the efficacy from under-medication. Current dosing schemes result in either too much drug exposure or too little drug exposure because of individual pharmacokinetic variations. The Autotelic pipeline includes TDM devices for management of oncology, hypertension and pain. More information is available at www.autotelicinc.com.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as "assumes," "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the Trabedersen; and the clinical development and commercial potential of Trabedersen. All such forward-looking statements are based on Oncotelic's current beliefs and expectations, and should not be regarded as a representation by Oncotelic that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Oncotelic's businesses, including: the company may require substantial additional funding in order to obtain regulatory approval for and commercialize any products; the risk that delays in the regulatory approval or commercial launch of Trabedersen will enable competitors to develop and bring new competing products to market before the approval, if any, of Trabedersen; the scope and validity of patent protection for Trabedersen as well as Oncotelic's platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; and additional risks set forth in any of Oncotelic's public announcements. These forward-looking statements represent Oncotelic's judgment as of the date of this release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Oncotelic undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Media Contact: Larn Hwang Ph.D. Chief Executive Officer, Oncotelic Inc., 818-575-9505, info@oncotelic.com

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SOURCE Oncotelic Inc.



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