ensereptide (PXL01) / Promore Pharma - LARVOL DELTA

Lactoferrin-derived peptide PXL01 impacts nerve regeneration after sciatic nerve reconstruction in healthy and diabetic rats. (PubMed, Front Cell Dev Biol) - "Diabetes influenced nerve regeneration in such autografts. Therefore, PXL01 is a promising candidate to improve nerve regeneration."

Journal • Preclinical • Diabetes • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • ATF3 • CASP3 • CD68 • HSPB1 • MRC1

PXL01 alters macrophage response with no effect on axonal outgrowth or Schwann cell response after nerve repair in rats. (PubMed, Regen Med) - " Despite a lower number of pan-macrophages, other investigated variables in sciatic nerves or DRGs did not differ between the treatment groups. PLX01 applied locally inhibits inflammation through pan-macrophages in repaired sciatic nerves without any impact on nerve regeneration or pro-healing macrophages."

Journal • Preclinical • Inflammation • CD68 • MRC1

Flexor Tendon Adhesion Formation: Current Concepts. (PubMed, Hand Clin) - "Unfortunately, however, these methods are accompanied by drawbacks, both large and small, and no absolute antiadhesion method capable of maintaining tendon repair strength has yet been developed. Recent innovations in biomaterials science and tissue engineering have produced new antiadhesion technologies, such as barriers combined with cytokines and cells, which have improved outcomes in animal models, and which may find clinical relevance in the future."

Journal • Review

Karolinska Development AB (publ) - Interim report January - September 2012 (Karolinska) - "Pergamum also reported top-line Phase II data with PXL-01, which unfortunately did not meet the primary end point and has negatively affected the reported valuation of Karolinska Development’s total portfolio holding. The company is now awaiting a complete analysis of the data before making a decision on further development."

Anticipated P2 data • P2 data • Fibrosis

Pergamum completes patient recruitment to the phase II clinical trial for prevention of post-surgical adhesions (Reuters) - P2, N=138; PHSU02; Pergamum AB announced that the last pt has been dosed in a randomized Phase II trial of PXL01 for prevention of post-surgical adhesions; The final pt will be followed-up for a period of 12 weeks & results from the study are expected to be presented later this year

Anticipated P2 data presentation • P2 enrollment completion • Fibrosis

Pergamum reports top line phase II-data from the clinical trial for prevention of post-surgical adhesions (Pergamum) - P2, N=138; NCT01022242; The study showed that the drug was safe and well tolerated; The primary end point of the study was not met; However, the data suggests that PXL-01 may improve the postoperative outcome regarding the hand mobility after surgery; The study did not show any difference between the group that were treated with PXL-01 & the pbo group measured as TAM2 (Total Active Motion, sum of two finger joints); The final phase II report is expected to be published in Q3 2012; Anticipated study completion in Feb 2013

Anticipated enrollment status • P2 data • Fibrosis