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Diffusion Pharmaceuticals Inc. (DFFN) is a clinical-stage biopharmaceutical company dedicated to enhancing the efficacy of standard-of-care therapies for life-threatening, treatment-resistant solid cancerous tumors. The company's flagship product, Trans Sodium Crocetinate (TSC), focuses on re-oxygenating the hypoxic (oxygen-deprived) microenvironment of tumors, thereby improving the effectiveness of conventional treatments like radiation and chemotherapy.
TSC has earned the Orphan Drug Designation from the FDA for its application in several cancers where tumor hypoxia undermines current therapeutic strategies. This innovative drug targets the hypoxic areas within tumors, making the cancer cells more susceptible to established treatments without adding harmful side effects.
Diffusion Pharmaceuticals is preparing to embark on a pivotal Phase 3 trial in glioblastoma (GBM), a particularly aggressive form of brain cancer, by 2016. Additionally, the company has plans for Phase 2/3 trials in pancreatic cancer and brain metastases, reflecting the broad applicability of TSC's unique mechanism of action across various tumor types.
Financially, Diffusion Pharmaceuticals is strategically positioning itself with strong partnerships and an innovative pipeline, aiming to make significant strides in cancer treatment. The company's ongoing projects and achievements underscore its commitment to revolutionizing oncological care by leveraging TSC's potential to safely and effectively re-oxygenate diverse tumor tissues.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) has initiated the ILD-DLCO Trial, the third in a series of Oxygenation Trials to assess trans sodium crocetinate (TSC) for treating interstitial lung disease (ILD). This double-blind, randomized, placebo-controlled study will include 27 ILD patients, evaluating TSC's effect on oxygen uptake efficiency. Results are expected by mid-2022. The company aims to expand TSC's applications in hypoxic conditions, including solid tumors, planning FDA consultations for its clinical program early next year.
Diffusion Pharmaceuticals (NASDAQ: DFFN) has received U.S. Patent No. 11,185,523 for the use of its lead product candidate, trans sodium crocetinate (TSC), in combination with chemotherapy and radiotherapy for cancer treatment. This patent enhances the company's intellectual property protection and supports its clinical program aiming to treat hypoxic solid tumors. The CEO expressed confidence in TSC's potential therapeutic value, aligning with the company's focus on clinical advancements in oxygen delivery therapies.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) has initiated the Altitude Trial, dosing the first participants to evaluate trans sodium crocetinate (TSC) under hypoxic conditions. This double-blind, placebo-controlled study aims to assess TSC’s impact on oxygen consumption and blood oxygen levels during exercise. With 30 volunteers planned for enrollment, results are expected by early 2022. The trial is part of a series to inform future clinical applications for TSC, particularly for treating hypoxic solid tumors, with regulatory consultations anticipated in early 2022.
Diffusion Pharmaceuticals (NASDAQ: DFFN) reported Q3 2021 results, with R&D expenses decreasing to $2.1 million from $3.1 million year-over-year, and G&A expenses down to $1.9 million. However, a non-recurring asset impairment charge of $8.6 million resulted in an increased operating loss of $12.6 million. The company plans to initiate the Altitude Trial in November and the ILD-DLCO Trial by year-end 2021, focusing on TSC for treating hypoxic tumors. With cash reserves of approximately $40.3 million, Diffusion expects to fund operations through 2023.
Diffusion Pharmaceuticals (NASDAQ: DFFN) will participate in the 2021 Alliance Global Partners Biotech & Specialty Pharma Conference on November 10, 2021. The company focuses on developing therapies that improve oxygen delivery to tissues, particularly for conditions associated with hypoxia. Interested investors can schedule one-on-one meetings with management on the same day. Diffusion's lead candidate, TSC, aims to address low oxygen levels in critical medical scenarios, while another candidate, DFN-529, is in early-stage development targeting the PI3K/Akt/mTOR pathway.
Diffusion Pharmaceuticals (NASDAQ: DFFN) CEO Robert Cobuzzi Jr. outlines recent advances and strategic changes in a letter to shareholders. Key updates include completion of the TCOM study, which showed TSC was safe and well-tolerated, and that it may enhance tissue oxygenation. Future trials, Altitude and ILD-DLCO, aim to further evaluate TSC's effects and inform future development. The company anticipates sufficient funding through mid-2023 to proceed with planned trials and is optimistic about TSC's potential in treating hypoxia-related conditions.
Diffusion Pharmaceuticals (NASDAQ: DFFN) announced that CEO Robert Cobuzzi, Jr., Ph.D., will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13-15, 2021. The prerecorded presentation will be accessible via the conference's virtual platform starting at 7 a.m. ET on September 13 and will remain available for 90 days. Dr. Cobuzzi will discuss the company’s business highlights, clinical achievements, and upcoming milestones for trans sodium crocetinate (TSC). Additionally, the management team will hold virtual one-on-one meetings with registered investors.
Diffusion Pharmaceuticals (NASDAQ: DFFN) has received FDA clearance for an Investigational New Drug (IND) application for its lead candidate, trans sodium crocetinate (TSC), aimed at treating Interstitial Lung Disease (ILD). This marks the fourth IND clearance for TSC across various FDA divisions, reflecting its broad therapeutic potential. A Phase 2 clinical trial will evaluate TSC’s efficacy in enhancing oxygen diffusion in ILD patients, set to commence in Q4 2021. Results will influence the selection of TSC’s dosing regimen and its initial lead indication, expected by year-end 2021.
Diffusion Pharmaceuticals (NASDAQ: DFFN) reported positive outcomes in its Phase 1b COVID-19 and TCOM studies, emphasizing a significant improvement in oxygenation and safety for its lead product, TSC. The company plans to announce the initial indication and regulatory pathway for TSC in Q4 2021, with a clinical outcome study expected in H1 2022. Diffusion anticipates having sufficient cash to fund operations through 2023, indicating a strong financial position with $43.3 million in cash as of June 30, 2021.
Diffusion Pharmaceuticals (NASDAQ: DFFN) announced positive topline results from its Phase 1 trial of trans sodium crocetinate (TSC), showing a positive dose-response trend in TCOM readings for peripheral tissue oxygenation compared to placebo. Although the results were not statistically significant due to the small sample size, TSC demonstrated safety and tolerability with no serious adverse events. The trial is part of Diffusion's ongoing Oxygenation Trials, which aim to develop TSC further for commercialization. The company anticipates completing additional trials in late 2021.
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