Oncotelic Therapeutics Inc - OTLC STOCK NEWS

Oncotelic Therapeutics (OTCQB:OTLC) has submitted a clinical study protocol to the US FDA for a Phase 2 trial (M201) of OT-101, its TGF-β inhibitor, combined with Anti-PD-1 (Pembrolizumab) for treating Malignant Pleural Mesothelioma (MPM). OT-101 is a first-in-class RNA therapeutic showing efficacy in cancer and has demonstrated activity against the SARS-CoV-2 virus. The trial aims to assess TGF-β inhibition's impact on various solid tumors while evaluating changes in the tumor microenvironment.

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) released its Q3 2021 financial results, reporting a net loss of $1.6 million, down from $2.0 million in Q3 2020. Total operating expenses rose to $1.8 million, driven by a $0.3 million decline in R&D costs and a $0.5 million increase in general and administrative expenses. The company secured $1.5 million in debt financing for a joint venture with Golden Mountain Partners (GMP) to advance its product pipeline, including OT-101. The promising efficacy signals from OT-101 for COVID-19 treatment were highlighted, with a reduction in mortality rates during trials.

Oncotelic Therapeutics (OTCQB:OTLC) announced positive results from its COVID-19 trial (C001) for OT-101, a first-in-class anti-TGF-β therapeutic. The trial met its safety and efficacy endpoints, showing a 4.5% mortality rate for OT-101 compared to 20% for placebo. Additionally, it achieved a viral load knockdown of 89% versus 67% for placebo, and improved survival for critical patients from 4 days (placebo) to 14 days (OT-101). These results support the further development of OT-101 for severe respiratory infections, including COVID-19.

Oncotelic Therapeutics (OTCQB:OTLC) announced progress in its ongoing OT-101/IL-2 combination trial, successfully completing the safety evaluation phase. This advancement allows for expansion into Phase 2 clinical trials and increased dosage levels. OT-101 is a first-in-class TGF-β targeting therapeutic, showing promising safety and efficacy in patients with advanced solid tumors. The optimal dosage from prior trials is being explored further. Results from this trial could enhance cure rates for metastatic kidney cancer and melanoma.

Oncotelic Therapeutics (OTCQB:OTLC) provided an update on its Phase 2 C001 Covid Study and the OT-101-ONC program, focusing on TGF-β immunotherapy for oncology and virology. Data lock for the Covid study was completed, with top-line results pending data analysis. The OT-101-ONC program has expanded to target cancers like mesothelioma and pancreatic cancer, supported by partnerships with leading pharmaceutical companies. Ongoing clinical trials with IL-2 and PD-1 inhibitors are expected to advance in 2021-2022. Oncotelic aims to enhance treatment outcomes for cancer patients.

Oncotelic Therapeutics (OTLC) has signed an exclusive licensing agreement with Autotelic Inc. for the development of AL-101, an intranasal apomorphine treatment targeting Parkinson's Disease and Erectile Dysfunction. The company aims to leverage the 505(b)2 regulatory pathway to expedite AL-101's market entry, having completed six clinical trials involving over 200 patients. Given the rising incidence of Parkinson's and unmet needs in sexual dysfunction, the acquisition positions Oncotelic for significant growth in these markets.

Oncotelic Therapeutics (OTCQB:OTLC) has signed a binding term sheet with Autotelic Inc. to license AL-101, an intranasal apomorphine aimed at treating Parkinson Disease (PD), Erectile Dysfunction (ED), and Female Sexual Dysfunction (FSD). This product will utilize the fast-to-market 505(b)2 regulatory pathway. AL-101 has completed six clinical trials with over 200 patients, demonstrating safety and efficacy. The growing incidence of PD and ED highlights the potential market for AL-101, offering a new therapeutic alternative for treatment-resistant patients.

Oncotelic Therapeutics (OTCQB:OTLC) announced positive results from its ARTI-19 clinical trial assessing PulmoHeal/ArtiVeda for treating mild to moderate COVID-19. The study demonstrated significant efficacy, with the artemisinin+SOC group showing faster improvement in WHO severity scale scores and respiratory metrics compared to standard of care. No serious side effects were reported, and the treatment was well-tolerated. This promising data will support Oncotelic's regulatory submission for marketing approval. The company aims to expand PulmoHeal/ArtiVeda's market presence as phytomedicine.

Oncotelic Therapeutics (OTCQB:OTLC) has formed a joint venture with Golden Mountain Partners to accelerate the clinical development of its pharmaceutical pipeline. An initial investment of $1.5 million from GMP aims to enhance commercialization efforts. This partnership builds on a relationship that began in 2020, focusing on therapies for oncology and COVID-19. Oncotelic plans to pursue an initial public offering (IPO), looking to replicate recent successes in TGF-β asset IPOs. The CEO expresses optimism for swift advancements in treatment availability.