Shield Therapeutics
MA - Wellesley
Biotechnology3 H-1B visas (FY2023)Focus: Small Molecules
Shield Therapeutics is a life sciences company focused on Small Molecules.
Oncology
Open Jobs
0
Products & Portfolio (2)
ABIRATERONE ACETATE
abiraterone acetate
Post-LOE
ORAL · TABLET
abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17α-hydroxy derivatives by 17α-hydroxylase activity and 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20-lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by abiraterone can also result in increased mineralocorticoid production by the adrenals [see ] . Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor. Abiraterone acetate decreased serum testosterone and other androgens in patients in the placebo-controlled clinical trial. It is not necessary to monitor the effect of abiraterone acetate on serum testosterone levels. Changes in serum prostate specific antigen (PSA) levels may be observed but have not been shown to correlate with clinical benefit in individual patients.
combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)prostate cancer
2023
30
ACCRUFER
ferric maltol
Peak
ORAL · CAPSULE
12.1 Mechanism of Action ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. 12.2 Pharmacodynamics ACCRUFER has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT) in adults and pediatric patients 10 years and older. 12.3 Pharmacokinetics Adults The pharmacokinetic properties of serum iron after administration of ACCRUFER was assessed in subjects with iron deficiency (with or without anemia) following a single dose and at steady state (after 1 week) of ACCRUFER 30 mg, 60 mg, or 90 mg twice daily (1 to 3 times the approved recommended dosage). Total serum iron concentrations increase in a less than dose proportional manner with increasing ACCRUFER doses. Total serum iron peak values were reached 1.5 to 3 hours after administration of ACCRUFER, and were comparable between Day 1 and Day 8. Pediatric Population In a pharmacokinetic substudy of the FORTIS trial [see Clinical Studies ( )] in pediatric patients with iron-deficiency anemia, ferric maltol 15 mg or 30 mg was administered orally twice daily, for 7-10 days in children aged 10 to <18 years. After a single dose of 30 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 119 µg/dL) at 2 hours, with a AUC 0-t of 374 h·µg/dL in children aged 12 to <18 years. After a single dose of 15 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 40 µg/dL) at 2.1 hours, with a AUC 0-t of 60.1 h·µg/dL in children aged 10 to 11 years. No accumulation of maltol glucuronide was observed. Absorption ACCRUFER dissociates upon uptake from the gastrointestinal tract allowing iron and maltol to be absorbed separately. Effect of Food Food has been shown to decrease the bioavailability of iron after administration of ferric maltol capsules. Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric maltol in vitro at pH 1.2, 4.5 and 6.8, only mycophenolate and ethinyl estradiol showed any potential for interaction. Mycophenolate recovery was reduced by up to 16% at pH 1.2 but there was no interaction at pH 4.5; due to solubility issues data are not available for pH 6.8. Ethinyl estradiol recovery was reduced by up to 35% at pH 4.5; due to solubility issues data are not available for pH 1.2 and pH 6.8. These potential oral interactions can be avoided by spacing the administration of those drugs and ACCRUFER [see Drug Interactions ( )] . Lisinopril, metoprolol and warfarin showed no interaction at any of the 3 pH conditions and can be taken with ACCRUFER. No interaction with ferric maltol was observed for atorvastatin (pH 6.8), and norgestimate (pH 1.2) (data were not obtainable at the other pH conditions due to solubility issues). In vivo No clinical studies evaluating the drug interaction potential of ACCRUFER have been conducted. Iron-containing preparations may decrease ciprofloxacin absorption into the bloodstream, resulting in lower serum a
iron deficiency in adultolder
2019
0
Open Jobs (0)
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Interview Prep Quick Facts
Portfolio: 2 approved products
Top TAs: Oncology
H-1B (2023): 3 approvals
Portfolio Health
Peak1 (50%)
Post-LOE1 (50%)
2 total products
Visa Sponsorship
Sponsors Work Visas
H-1B Petitions (FY2023)
3
Approved
0
Denied
100%
Rate
Source: USCIS H-1B Employer Data Hub