AGOURA HILLS, CA, Feb. 13, 2019 (GLOBE NEWSWIRE) -- Oncotelic - a clinical stage biopharmaceutical company focused on the treatment of cancer with in situ cancer vaccine - today announced plan for its registration trials which are meant to confirm the clinical outcome of its phase 2 trials.
During the Phase 1/2 P001 trial of OT-101, disease control (CR+PR+SD) was achieved 19 of 35 evaluable pancreas cancer pts (54%). Importantly, 1 yr survival of metastatic pancreas cancer pts was 19% (7 of 36 pts alive) which was improved to 35% (5 of 14 pts alive) among pts with liver metastasis only. These values are significantly higher than the 7% (8 of 117 pts alive) and 6% (7 of 119 pts alive) among comparable populations treated with Onivyde+5FU/LV and 5FU/LV, respectively, (p<0.05 vs. all pts and p<0.005 vs. pts with liver metastasis only). Notably, lasting objective responses (as long as 77 months) were observed in heavily pretreated individual patients with liver metastases.
During the G004 phase 2b trial of OT-101, the 2-year survival of the chemo naïve recurrent high-grade glioma patients treated with intratumor administratons of OT-101 was 33.3% (15 of 45 patients alive), whereas the survival of patients treated with the standard chemotherapy drug temozolomide was 5.6% (1 of 18 patients alive). This favorable survival difference for the OT-101 group was statistically significant (p=0.0258). The 2-year survival further improved to 50% (15 of 30 patients alive; P=0.0015) by combining OT-101 with temozolomide
Detailed results were presented 11th AACR-JCA Joint Conference on Breakthroughs in Cancer Research:Biology to Precision Medicine in Maui, Hawaii and available for download at www.oncotelic.com.
“We are excited and proud to be presenting these very promising survival data for these difficult to treat cancers,” said Vuong Trieu, Ph.D., CEO of Oncotelic. “There remains significant unmet need with a majority of patients failing to respond to checkpoint inhibition. Our exceptional clinical results among high grade gliomas and heavily pretreated metastatic pancreas cancers validate the growing conviction that TGF beta inhibitors will be the next wave in immunotherapy.”
“The in situ cancer vaccine of Oncotelic is designed to robustly reactivate exhausted immune cells around the cancer tissue. The single agent efficacy signals observed in these early clinical trials of OT-101 contribute to our optimism regarding the clinical impact potential of Oncotelic’s in situ vaccine strategy. We hope to diligently advance the clinical development of OT-101 clinical development through carefully designed, controlled registration trials with the vision of bringing a new treatment option to cancer patients who are in urgent need for therapeutic innovations.”, said Fatih Uckun, MD, PhD, CMO of Oncotelic.
About Oncotelic Inc.
Oncotelic is a privately held cancer immunotherapy company dedicated to the development of first in class in situ cancer vaccine as durable cure for difficult to treat cancer. This therapeutic cancer vaccine does not require extraction of the tumor and isolation of the antigen for immunization- a lengthy/laborious process with limited clinical effectiveness and has a broad-spectrum applicability for multile cancer types . It showed promising clinical activity in phase 2 trials for the treatment of glioblastoma and pancreatic cancer. The company aims to translate its unique insights spanning three decades with original work at Genetic Therapy Inc using adenovirus as RNA therapeutics to the current deployment of antisense as RNA therapeutics for diseases caused by TGF-beta overexpression including cancer. The founding team of Oncotelic was responsible for the development of Abraxane as chemotherapeutic agents for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has $1B in sales annually and Cynviloq, a next generation Abraxane, was acquired by NantPharma for $1.9B. Oncotelic will leverage its deep expertise in oncology and RNA therapeutic drug development to promote the eventual cure and eradication of cancers. The team is leveraging the antisense platform for rapid drug development while avoiding mistakes made by others in the field who targeted the wrong targets or the wrong tissues. Properly developed, antisense RNA therapeutics have the potential to be superior to mAb platform. Example would be from mutation identification to drug into patient in less than a year with Milasen. 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. Words such as “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will be”, “conviction”, "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Oncotelic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Oncotelic's product candidate OT-101, and the potential use of our product candidates to treat various cancer indications. Many factors may cause 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 Oncotelic's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Except as required by law, Oncotelic assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.