On May 31, 2023 Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company, reported that it will present new data from its metastatic prostate cancer program during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago, as well as from its anal fissure program during the upcoming American Society of Colon and Rectal Surgeons (ASCRS) Annual Meeting being held June 3-6 in Seattle (Press release, Tavanta Therapeutics, MAY 31, 2023, View Source [SID1234632304]).
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"At ASCO (Free ASCO Whitepaper), we will present detailed Phase 3 results for TAVT-45 that further demonstrate its potential to become the first FDA-approved oral suspension formulation of abiraterone acetate for patients with metastatic prostate cancer and provide a much-needed alternative for patients with dysphagia," said Andreas Maetzel, M.D., Ph.D., Chief Medical Officer of Tavanta Therapeutics. "At ASCRS, we are excited to present the first data from our Phase 2 study of TAVT-119 in people with anal fissure. Currently, non-surgical options to treat anal fissures include topical nitrates (which are limited by headache/tolerability) and topical calcium channel blockers (which are only available via compounding pharmacies as none are FDA-approved for anal fissure). Based on the data that will be presented, we believe that TAVT-119 has the potential to offer patients a therapeutic option that is safe, efficacious and accessible."
"We are pleased to highlight these promising new data, which reflect the significant progress of our clinical development programs," said Lynne Powell, Chief Executive Officer of Tavanta Therapeutics.
Details of presentations are as follows:
ASCO Presentation
Poster: A Novel Abiraterone Acetate Oral Suspension for Patients with Metastatic Prostate Cancer: An Open-Label, Phase 3, Randomized Trial
Poster Number: 146
Date: Saturday, June 3, 2023
Poster Session Time: The poster will be presented from 8:00 – 11:00 a.m. CDT, during the "Genitourinary Cancer—Prostate, Testicular, and Penile" poster session
The Company’s abstract, which has been made available on the ASCO (Free ASCO Whitepaper) website can be viewed here. For more information about ASCO (Free ASCO Whitepaper) visit View Source
ASCRS Presentation
Poster: Phase 2 Study of TAVT-119 (amlodipine besylate) Gel in Patients with Chronic Anal Fissure
Poster Number: eP600
Date: Monday, June 5, 2023
Poster Session Time: An oral presentation of the ePoster will occur from 11:25 – 11:30 a.m. PDT, during the "ePoster Monitor 16 Benign Anorectal Disease" session
The Company’s abstract will be made available after the presentation on Tavanta’s website. For more information about ASCRS visit View Source
About Prostate Cancer and TAVT-45 Granules for Oral Suspension
Prostate cancer is the second leading cause of cancer in men.1 TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), is an enhanced formulation of abiraterone acetate, an androgen biosynthesis inhibitor. Abiraterone acetate is currently marketed in the U.S. and EU as Zytiga tablets for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 may provide an alternative for 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets. Other limitations of the commercially available abiraterone tablets include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure can result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.2,3 It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients with sub-optimal abiraterone trough plasma concentrations.
About Anal Fissures and TAVT-119 Gel
Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms, and are quite common in the general population.4 TAVT-119 is a novel topical formulation of amlodipine, a long-acting calcium channel blocker (CCB) that can relax smooth muscle and improve vasodilation. Amlodipine is currently marketed in the U.S. and EU as Norvasc tablets for treating hypertension and coronary artery disease. TAVT-119 gel is under development for treating moderate to severe pain associated with anal fissure. Current non-surgical treatment options for anal fissure include topical nitrates and CCBs. However, topical nitrates are associated with side effects such as severe headaches, while CCBs are not approved in the U.S. to treat anal fissures and are often used off-label via compounding pharmacies.4,5 TAVT-119 has the potential to become the first FDA-approved CCB for anal fissure, which could overcome access/availability issues of compounded agents, with fewer adverse events expected compared to topical nitrates.