Pinnacle Spine

CA - San Clemente

Biotechnology

Website LinkedIn Careers Page

Focus: Interbody Fusion Systems

Pinnacle Spine is a life sciences company focused on Interbody Fusion Systems.

Musculoskeletal

Open Jobs

0

Products & Portfolio (1)

porfimer sodium

LOE Approaching

INJECTION · INJECTABLE

12.1 Mechanism of Action The cytotoxic and antitumor actions of PHOTOFRIN are light and oxygen dependent. Photodynamic therapy (PDT) with PHOTOFRIN is a two-stage process. The first stage is the intravenous administration of PHOTOFRIN. Clearance from a variety of tissues occurs over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain PHOTOFRIN for a longer period. The second stage is the illumination with 630 nm wavelength laser light. Tumor selectivity in treatment occurs through a combination of selective retention of PHOTOFRIN and selective delivery of light. Cellular damage caused by PDT with PHOTOFRIN is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. Subsequent radical reactions can form superoxide and hydroxyl radicals. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. As opposed to a thermal effect, the laser treatment with porfimer sodium induces a photochemical effect. The necrotic reaction and associated inflammatory responses may evolve over several days. 12.2 Pharmacodynamics The duration of the PDT effect of PHOTOFRIN is dependent on retention and clearance of porfimer sodium from the tumor tissue and delivery of light. Drug Interaction Studies Findings in animals and cell culture suggest that many drugs could influence the effect of PDT, including compounds that quench active oxygen species or scavenge free radicals; decrease clotting, vasoconstriction or platelet aggregation: glucocorticosteroids; allopurinol; calcium channel blockers; and some prostaglandin inhibitors. 12.3 Pharmacokinetics The pharmacokinetics of porfimer sodium were studied in 18 patients with cancer who received PHOTOFRIN 2 mg/kg/dose administered as a slow intravenous infusion over 3 to 5 minutes followed by a second dose administered 30 to 45 days later. The mean C max were comparable after the first and second dose (43.1±10.5 mcg/mL and 41.3±8.7 mcg/mL, respectively). The mean AUC 0-INF was about 34% higher after the second dose compared to that after the first dose (3937±1034 mcg.h/mL and 2937±627 mcg. hour/mL, respectively), indicating some accumulation upon repeated administration. Distribution Clearance from a variety of tissues occurs over 40 to 72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period. Porfimer sodium was approximately 90% protein bound in human serum in vitro. The binding was independent of concentration over the concentration range of 20 to 100 mcg/mL. Elimination The elimination half- life is 410 hours after the first dose and increases to 725 hours after the second dose. Specific Populations No clinica

microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgeryradiotherapy are not indicatedobstruction+3 more

Open Jobs (0)

No open positions listed yet. Check their careers page directly.

Interview Prep Quick Facts

Portfolio: 1 approved product

Top TAs: Oncology

Portfolio Health

LOE Approaching1 (100%)

1 total products

Therapeutic Area Focus

1 marketed

Marketed

Pipeline