VivaGel (astodrimer vaginal) / Starpharma - LARVOL DELTA

Advances in Dendrimer-Based Anti-Infective Systems: In Vivo Insights and Perspectives. (PubMed, Pharmaceutics) - "PAMAM systems are the most extensively explored preclinically, whereas poly(L-lysine) dendrimer astodrimer/SPL7013 remains the most clinically advanced example...Direct comparison across studies is limited by differences in dendrimer scaffold, generation, surface chemistry, formulation, pathogen, infection model, administration route, dosing regimen, and biological endpoint. Future development will require better-defined in vivo models, more systematic safety and biodistribution studies, clearer structure-activity relationships, and stronger links between in vitro activity and clinically relevant efficacy."

Journal • Preclinical • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Vaginitis

Starpharma Receives $5.5M R&D Tax Incentive Refund (Starpharma Press Release) - "'Starpharma is pleased to announce the receipt of $5.5 million under the Australian Government’s R&D Tax Incentive program. This program is important in driving innovation and product development within our sector, enabling local companies to invest in addressing significant health challenges.'....'We are continuing to focus on translating this progress into tangible results that align with our three strategic priorities: maximising DEP asset value, accelerating early asset development, and building long-term sustainability.'"

Financing • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Infectious Disease • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Solid Tumor

Design of polypeptide-based nanoconjugates as advanced theranostics (ACS-Fall 2023) - "Synthetic polypeptide-based nanomedicines represent highly versatile, advanced therapeutic platforms, with multiple examples currently under clinical evaluation and polypeptidic drugs (Vivagel® and Copaxone™) achieving market approval. Deprotection steps ensured the complete removal of protecting groups without racemization. This approach can be combined with post-polymerization strategies to conjugate drugs as single agents or in combination therapy using bioresponsive linking moieties that react to factors within the tumor environment."

Metastases • Oncology

Astodrimer sodium and bacterial vaginosis: a mini review. (PubMed, Arch Gynecol Obstet) - "Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition."

Journal • Review • Infectious Disease • Obstetrics • Vaginitis

Topical Astodrimer Sodium, a Non-Toxic Polyanionic Dendrimer, Demonstrates Antiviral Activity in an Experimental Ocular Adenovirus Infection Model. (PubMed, Molecules) - "In a tolerability study, rabbits were treated with 3% SPL7013, vehicle, or 0.5% cidofovir. The 3% SPL7013 induced "minimal" to "practically non-irritating" Draize scores in the ocular tolerability study. Further development of astodrimer sodium as a topical antiviral therapy for adenoviral ocular infections is indicated."

Journal • Infectious Disease • Ocular Infections • Ophthalmology

Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. (PubMed, Antiviral Res) - "Further studies will confirm if astodrimer sodium binds to SARS-CoV-2 spike protein and physically blocks initial attachment of the virus to the host cell. Given the in vitro effectiveness and significantly high SI, astodrimer sodium warrants further investigation for potential as a topically administered agent for SARS-CoV-2 therapeutic applications."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Astodrimer Gel for Treatment of Bacterial Vaginosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Int J Clin Pract) - "Astodrimer gel is effective in treating bacterial vaginosis and corroborated by clinical (Amsel criteria) and microbiological (Nugent score) measurements as well as patient-reported symptoms. Moreover, astodrimer gel is largely safe and associated with marginal rate of vulvovaginal candidiasis."

Clinical • Retrospective data • Review • Candidiasis • Vaginitis

A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis. (PubMed, Eur J Obstet Gynecol Reprod Biol ) - "864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Vulvovaginal candidiasis and urinary tract infection occurred more often in women receiving astodrimer. Astodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated."

Clinical • Journal • P3 data • Candidiasis • Infectious Disease • Nephrology • Vaginitis

"Starpharma SPL7013 Nasal Spray for COVID-19 – Development Update https://t.co/MUXA9w6RMc" (,@NewsFromBW)

Infectious Disease • Novel Coronavirus Disease

A phase 2, double-blind, multicenter, randomized, placebo-controlled, dose‑ranging study of the efficacy and safety of Astodrimer Gel for the treatment of bacterial vaginosis. (PubMed, PLoS One) - "Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis."

Clinical • Journal • P2 data

Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "These results support a role for Astodrimer 1 % Gel as an effective, safe and well-tolerated treatment for women with bacterial vaginosis."

Clinical • Journal • P3 data