talactoferrin oral (oral rhLF) / Agennix - LARVOL DELTA

Fragmented antibodies in non-small cell lung cancer: a novel nano-engineered delivery system for detection and treatment of cancer. (PubMed, Drug Discov Today) - "When combined with functional nanocarriers, antibody fragments can target cancer cells while offering improved efficacy and fewer off-target effects. We discuss current topics of interest including anti-CTLA-4 mAbs, Talactoferrin alfa (TLF), and the CYFRA 21-1 biomarker, with brief insights into its novel detection system."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Topical gel-based biomaterials for the treatment of diabetic foot ulcers. (PubMed, Acta Biomater) - "A summary of these approaches is needed to help better understand the current state of the research.. This review summarizes recent research and advances in topical biomaterials treatments for DFUs."

Journal • Review • Diabetes • Infectious Disease • Metabolic Disorders • Oncology

The Role of Recombinant Proteins and Growth Factors in the Management of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials. (PubMed, J Diabetes Res) - "We identified 26 RCTs involving diabetic patients with ulcer that evaluated the effectiveness of platelet-derived growth factor, epidermal growth factor, fibroblast growth factor, granulocyte colony-stimulating factor, vascular endothelial growth factor, erythropoietin, transforming growth factor, talactoferrin, and rusalatide acetate. Overall, there is a greater agreement on the effectiveness of EGF to enhance the healing of diabetic ulcers. Nevertheless, extant evidence is lacking for other agents since few trials have been conducted for most of the growth factors and available studies are heterogeneous in their methodologies."

Clinical • Journal • Review • Diabetes • EPO • FGF • VEGFA

Which Multicenter Randomized Controlled Trials in Critical Care Medicine Have Shown Reduced Mortality? A Systematic Review. (PubMed, Crit Care Med) - "A systematic literature search provided no conclusive evidence of any pharmacologic intervention that has consistently reduced mortality in critically ill patients. Strategies associated with improved or noninvasive mechanical ventilation were associated with reduced mortality."

Clinical • Journal • Review • Acute Respiratory Distress Syndrome • Critical care • Infectious Disease • Respiratory Diseases • Septic Shock

Talactoferrin Phase II trial in non-small cell lung cancer shows promise (Medical News Today) - P2, N=100; Talactoferrin improved median OS by 65% compared to PBO group (6.1 months vs. 3.7 months, p=0.04 [one-tailed log-rank test]), reaching the protocol-defined level of statistical significance; For those in the talactoferrin group, the six-month OS was 52% vs. 30% in the PBO group; Patients in the PBO group had a one-year OS rate of 16% vs. 29% in the talactoferrin group; Enrollment for the P3 FORTIS-M trial has been completed and the results expected in the H1 2012

Anticipated P3 data • P2 data • Non Small Cell Lung Cancer

Agennix AG announces notice of allowance for U.S. patent application covering use of talactoferrin alfa to treat non-small cell lung cancer and renal cancer in combination with other treatments (Agennix) - Agennix AG announces that the U.S. Patent & Trademark Office has issued a Notice of Allowance for patent application US 12/964,327, entitled, Lactoferrin in the treatment of malignant neoplasms & other hyperproliferative diseases; The patent application covers the use of the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin alfa (talactoferrin) for the treatment of NSCLC & renal cancer in combination with chemotherapy, biotherapy, immunotherapy, surgery, radiotherapy, or a combination thereof

Patent • Non Small Cell Lung Cancer

Agennix reports results of FORTIS-M phase III trial with talactoferrin alfa in non-small cell lung cancer (Agennix) - P3, N=742; FORTIS-M; Trial did not meet its primary endpoint of improving OS; The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in pts with NSCLC whose disease had progressed following two or more prior treatment regimens; Median OS in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (p=0.66)

P3 data • Non Small Cell Lung Cancer

BIO CEO & Investor Conference (Agennix) - Talactoferrin / Agennix; Anticipated FORTIS-M Phase 3 trial in 3rd line+ NSCLC top line data expected in Q2 2012; Anticipated approval of talactoferrin in 2013

Anticipated approval • Anticipated top-line data • Non Small Cell Lung Cancer • Oncology

Agennix concludes patient recruitment in Talactoferrin phase III FORTIS-M trial (Pharmaceutical Business Review (PBR)) - FORTIS-M; P3, N=NA; Agennix has concluded pt recruitment in Talactoferrin FORTIS-M Phase III global randomized, double-blind registration trial

Oncology

Safety and efficacy of Talactoferrin in previously treated patients with non-small cell lung cancer (FORTIS-M) (clinicaltrials.gov) - P3, N=720; Completed → Active not recruiting; Completion date Mar’11 → Mar’13

Completion date • Enrollment closed

FORTIS-M, a randomized, double-blind, placebo-controlled phase 3 study of oral Talactoferrin alfa with best supportive care in patients with advanced non-small cell lung cancer following two or more prior regimens- by the FORTIS-M study group (ESMO 2012) - P3, N=742; FORTIS-M; The median OS for TLF was 7.49 months vs 7.66 months for placebo (p=0.6602); DCR was 37.6% for TLF & 38.4% for placebo (p=0.8336); 87.3% of pts in the TLF arm experienced an adverse event (AEs), 86.0% in the placebo arm; 36.4% of pts had Gr 3-4 AEs in the TLF arm, 35.5% in the placebo arm; TLF plus best supportive care did not extend OS or PFS vs placebo plus best supportive care in pts with advanced NSCLC

P3 data • Non Small Cell Lung Cancer

Bio Equity Europe (Agennix) - Anticipated top-line data of P3 FORTIS-M trial for NSCLC in Jul/Aug 2012; Anticipated composition of matter/production patent expiry in US in Q4 2013; Anticipated cancer use patent expiry in US in 2025; Anticipated composition of matter/production patent expiry in EU in Q4 2013; Anticipated cancer use patent expiry in EU in 2023

Anticipated P3 top line data • Anticipated patent expiry • Non Small Cell Lung Cancer

Agennix AG reports additional talactoferrin alfa data (Agennix) - P3, N=1,100; FORTIS-C; “Investigator-reported median PFS in the talactoferrin arm was 5.8 months compared to 5.6 months for placebo (hazard ratio 0.97, p-value 0.89). Median OS in the talactoferrin arm was 11.4 months compared to 12.7 months for placebo (hazard ratio 1.25, p-value 0.36). The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo.”

P3 data: top line • Non Small Cell Lung Cancer