Oncotelic Release: Results Of A Phase I/II Trial Of Ot-101 In Advanced Melanoma Patients
FOUNTAIN VALLEY, Calif., March 9, 2016 /PRNewswire-iReach/ -- Results of a Phase I/II trial of OT-101 in advanced melanoma patients
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Treatment with OT-101- an anti-TGF-beta 2 antisense- primed tumors to subsequent chemotherapies
Skin cancer is the most common form of cancer diagnosed in the United States. Despite comprising only 5% of skin cancers, malignant melanoma is the leading cause of skin cancer-related deaths annually. It appears that metastatic tumors, as well as the supportive cells that surround them, secrete extracellular matrix proteins which facilitates their escape and survive at a distant site. Many of the proteins over-expressed in the more aggressive tumors are activated by the same cellular signaling pathways, including the one controlled by TGF-beta. TGF-beta is often elevated in cancer cells- including melanoma cells. In this phase I/II trial of advanced metastatic melanoma, we examined the decloaking of the melanoma tumours by TGF-beta 2 antisense to allow for deep sustained OS. This antisense is being developed by Oncotelic as OT-101 (Trabedersen).
The primary objective was to determine the Maximum Tolerated Dose (MTD) and the DLTs of two cycles of Trabedersen administered i.v. for 7 days or for 4 days every other week. The secondary objectives include assessment of the potential antitumor activity of Trabedersen administered intravenously at weekly intervals and for four days every other week, as assessed survival. The patients had a histologically or cytologically confirmed diagnosis of melanoma, stage III or IV (AJCC 2002). The patients were not or no longer amenable to established forms of therapy with at least 1 measurable lesion, Karnofsky performance status of at least 80%, and recovered from acute toxicity caused by any previous therapy.
Previously we have reported on the syngergistic activity of Trabedersen and chemotherapy in xenograft model of melanoma (C8161). In this phase 1/2 melanoma clinical study, Trabedersen treatment was characterized by outstanding OS which was not supported by PFS. The effect was seen primarily when chemotherapies were used as subsequent therapies following Trabedersen treatment. The clinical data is in support of the decloaking of melanoma tumours to subsequent chemotherapies following Trabedersen treatment.
Poster Session
Meeting : HemOncToday Melanoma and Cutaneous Malignancies Conference 2016
Location : Sheraton New York Times Square Hotel, New York, USA
Date and Time : Friday March 18, 5:45pm - 6:45pm in Riverside Ballroom (Exhibit hall)
Title : Treatment with OT-101- an anti-TGF-beta 2 antisense- primed tumors to subsequent chemotherapies
Authors : Vuong Trieu1, Kevin Ng2, Larn Hwang1
Institutions : 1Oncotelic Inc. Agoura Hills, CA 91301; 2Autotelic Inc., Fountain Valley, CA 92708
bout Trabedersen
Trabedersen, (OT-101) is 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. OT-101 has completed multiple clinical trials and is poised for multiple phase 2 combination trials followed by pivotal phase 3 registration trials.
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 which are 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.
