Pill with g12
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Overview of G12-Related Medications
BG-12 (Dimethyl Fumarate) for Multiple Sclerosis
Efficacy and Safety in Relapsing-Remitting Multiple Sclerosis
BG-12, also known as dimethyl fumarate, is an oral medication developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). A phase 3, placebo-controlled study evaluated the efficacy and safety of BG-12 at doses of 240 mg taken either twice or three times daily. The study included a comparison with glatiramer acetate, a commonly used injectable treatment for RRMS.
Reduction in Relapse Rates and Lesions
The results demonstrated that both dosing regimens of BG-12 significantly reduced the annualized relapse rate compared to placebo. Specifically, the twice-daily and thrice-daily doses reduced the relapse rate by 44% and 51%, respectively, while glatiramer acetate achieved a 29% reduction. Additionally, BG-12 significantly decreased the number of new or enlarging T2-weighted hyperintense lesions and new T1-weighted hypointense lesions, indicating its effectiveness in reducing disease activity.
Adverse Events and Safety Profile
Common adverse events associated with BG-12 included flushing and gastrointestinal issues, whereas glatiramer acetate was associated with injection-related events. Importantly, no malignant neoplasms or opportunistic infections were reported with BG-12, although a decrease in lymphocyte counts was observed.
ZG19018 for KRAS G12C-Mutated Solid Tumors
First-in-Human Study and Dose Escalation
ZG19018 is a selective inhibitor targeting the KRAS G12C mutation, which is prevalent in various advanced solid tumors. A phase 1 study assessed the tolerability, safety, pharmacokinetics, and preliminary efficacy of ZG19018 in patients with KRAS G12C-mutated tumors who had progressed after standard therapies.
Tolerability and Adverse Events
The study included a rapid dose-escalation phase and a standard 3+3 design phase, with doses ranging from 50 mg once daily to 450 mg twice daily. The maximum administered dose was 450 mg twice daily, where dose-limiting toxicities included grade 3 elevations in γ-GGT and ALT. Common treatment-related adverse events were nausea, diarrhea, vomiting, and various liver enzyme elevations. No serious adverse events were reported.
Preliminary Antitumor Effects
Among the 12 patients evaluated for best overall response, 16.7% achieved partial response, 50% had stable disease, and 33.3% experienced disease progression. The maximum drug exposure was 8 months in a patient with colorectal cancer who maintained stable disease.
Conclusion
Both BG-12 and ZG19018 show promise in their respective therapeutic areas. BG-12 effectively reduces relapse rates and lesion counts in RRMS patients, with a manageable safety profile. ZG19018 demonstrates preliminary antitumor activity in KRAS G12C-mutated solid tumors, with tolerable adverse effects. Further studies are warranted to confirm these findings and optimize treatment protocols.
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