Looking back at the press releases it looks like Enmd did start back at phase I with the new Panzem formulation. I know I was thinking an in-house new formulation was going to start in ’04 at phase III. It looks like Enmd wanted the best formulation and so they started testing several new state of the art formulas at phase I again. That bridge study is now in the past and it looks like they are ready to move on to phase II/III with a superior formulation.
From the Nov ’03 press release: “When designing the new Panzem(R) [2-methoxyestradiol (2ME2)] formulation, EntreMed scientists investigated a number of technologies to produce over 25 new variations of Panzem(R). When tested in vivo, three of these formulations produced a two orders of magnitude increase in plasma concentrations of active 2ME2. Importantly, these plasma levels of 2ME2 obtained using the new Panzem(R) formulations are associated with maximum inhibition of tumor growth in preclinical models.” Looking back I bet Enmd was testing formulations from a number of different companies, one of them Elan’s formulation, which made it to the top three.
Then there was this press release from March ’04: “EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage biopharmaceutical company developing therapeutics primarily for the treatment of cancer, today announced that a new formulation of Panzem(R), the Company's lead clinical drug candidate, is currently being evaluated in a Phase I clinical trial. This formulation is being administered in various oral forms. The objectives of the trial in healthy human volunteers are to determine the pharmacokinetics and safety profiles of these dosage forms.” Looking back this sounds like the top three formulations were tested in a phase I or from the description, a combo phase I/II type study.
Then there was this press release from April ’04: “EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage biopharmaceutical company developing therapeutic candidates primarily for the treatment of cancer, today announced that the Company has concluded its Phase I clinical trial in healthy human volunteers with reformulated Panzem(R) (2-Methoxyestradiol or 2ME2). The Phase I trial evaluated the pharmacokinetics and safety profiles of several oral dosage forms of 2ME2. The best of these formulation approaches resulted in significantly higher peak blood levels of 2ME2 than those achieved with the original clinical formulation and demonstrated no additional toxicity.” I take it that the best formulation was Elan’s nanoparticle formulation.
From the July ’04 press release: “EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage biopharmaceutical company developing therapeutics primarily for the treatment of cancer, today announced that it has entered into a Clinical Supply Agreement with Elan Drug Delivery, Inc. to reformulate and manufacture EntreMed's Panzem(R) in an oral liquid product format. This supply of reformulated Panzem(R) will support EntreMed's clinical oncology program that is planned to begin in early 2005.” I don’t think they’ll be starting at phase I. I think in ’05 they’ll be starting at phase II/III.
Aaron
