The EC1456 poster shows the design and dosing schedule of the Phase 1 dose-escalation study of
The second poster presentation entitled "Real-time Identification of Tumor Lesions Likely to Respond to Vintafolide Treatment" shows the capability of etarfolatide to correctly identify in real-time nearly all tumor lesions that responded to folate-targeted therapy, whereas lesions that do not demonstrate etarfolatide uptake did not demonstrate major shrinkage following vintafolide treatment. The researchers evaluated 209 baseline lesions from patients in a Phase 2 open-label, multicenter study of the investigational agent vintafolide in advanced ovarian cancer (ClinicalTrials.gov Identifier: NCT00507741).
|Presentations are as follows:|
|Title:||A phase 1 dose-escalation study of EC1456, a folic acid-tubulysin small-molecule drug conjugate, in adult patients (pts) with advanced solid tumors|
|Session Title:||Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics|
|Location:||S Hall A2, Board 92B|
|Title:||Real-time Identification of Tumor Lesions Likely to Respond to Vintafolide Treatment|
|Session Title:||Gynecologic Cancer|
|Location:||E354b, Board 24|
About Vintafolide, Etarfolatide and IV Folic Acid
Vintafolide is an investigational conjugate of folic acid (vitamin B9) linked to an anti-cancer agent, the potent vinca alkaloid desacetylvinblastine hydrazide (DAVLBH). Since cancer cells generally consume higher levels of folate than normal cells to fuel their growth, some cancer cell types - including ovarian and NSCLC - have high concentrations of the folate receptor on their surface. Vintafolide is designed to selectively target the folate receptor to deliver the anti-cancer agent to the cancerous tissue. Tumors that have high concentrations of the folate receptor are identified by etarfolatide, a non-invasive imaging diagnostic agent. Intravenous folic acid is used with 99mTc-etarfolatidefor the enhancement of image quality.
Vintafolide, etarfolatide and IV folic acid have been granted orphan drug status by the EMA.
EC1456 is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. The targeting ligand folate, essential for cell division, has been investigated with vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).
Endocyte Forward-Looking Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the company's expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, and expectations for the receipt of milestones, royalties or other profits from the company's partnership with Merck. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, unavailability of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be
indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company's product candidates, the goals of its development activities, estimates of the potential markets for its product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected financial results. More information about the risks and uncertainties faced by
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