In 2011 the now late Professor Lars Heslet  (Anesthesiology, Intensive Care) and the now late Professor Niels Jørgen Secher (Obstetrics) contacted me. They asked me to help finding innovation height for a pending patent concerning local treatment of bleedings with recombinant, activated factor VII (rFVIIa). The female reproductive organs would be the targets.

After 3 months of searching it became clear to us that already in 1970 Bonnar J and his group had described that in the uterine circulation a striking local activating of the clotting mechanism was accompanied with the placental separation. Drake TA, Lockwood CJ, Mackmann N, Uhlén M and their groups found the highest expression and concentration of tissue Factor (TF) in the amnion fluid and in the decidual cells of the placenta site. 

Upon a bleeding the complexing of circulating rFVIIa with tissue-bound TF constitutes the biggest initiatiator and accelerator of the coagulation.

The European patent EP2004214 and the USA patent US20090093410  ”Methods for local treatment with FVII” were granted for the use against bleedings from the female genital tract. The patents are held by Stellaris Pharmaceuticals ApS, which I founded in 2012.

A Proof of Concept has been performed in 5 patients with placenta previa (PP) in cooperation with Professor Niels Uldbjerg and his group. Visually the inhibitory effects of local rFVIIa upon the bleeding placenta site were striking. We found no signs of rFVIIa entering the systemic circulation with no enhancement of the propensity for systemic coagulation (AJOG Article attached).

We are planning a multi-center, randomized, double-blinded, controlled study of local rFVIIa/placebo at the placenta site in women with PP. 

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