Aspart-PH20 (insulin aspart/rHuPH20) / Halozyme - LARVOL DELTA

Open-Label, Multicenter, Dose Escalation Phase 1b Study to Assess the Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (PAVO) (ASH 2016) - "Pre- and/or post-infusion medications included paracetamol, diphenhydramine, montelukast, and methylprednisolone. SC DARA-PH20 was well tolerated and achieved serum trough concentrations similar to or greater than IV DARA with a lower rate of IRRs compared to IV DARA over a significantly shorter infusion time. Preliminary data suggest that in this pt population SC DARA-PH20 may enable similar response rates to IV DARA monotherapy. The 1800 mg dose level of DARA-PH20 was selected as the RP2D for part 2 of the study."

Clinical • P1 data • Biosimilar • Cardiovascular • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

Safety/efficacy study of subcutaneously injected prandial insulins compared to insulin lispro alone in patients with type 2 diabetes mellitus - Halozyme Therapeutics / P2, N=110; Recruiting;

Diabetes

Randomized, Double-blind, Crossover, PK and GD Study of CSII in Subjects With Type 1 Diabetes - Halozyme Therapeutics; P1, N=36; Recruiting;

 

Diabetes

Halozyme's rHuPH20 With Recombinant Human Insulin Demonstrates Glycemic Control Comparable to Lispro (PRNewswire) -

P2, N=41; The results showed glycemic excursion of 17 +/- 36mg/dL for rHuPH20 and 14 +/- 35mg/dL for lispro (P=NS) and met the pre-specified non-inferiority margin of 21.6mg/dL; A1c measures were comparable for both treatments with 7.0 +/- 0.5 for rHuPH20 and 6.9 +/- 0.6 for lispro; Overall rate of hypoglycemia was also comparable

P2 data

Halozyme Therapeutics announces pricing of public offering of common stock (PRNewswire) - Halozyme announced public offering of 8.3M shares of its common stock at $7.50 per share; Offering is expected to close on Sep 14 ’10;

Diabetes

Halozyme begins phase 2 clinical trials with insulin analogs lispro and aspart with rHuPH20 in type 1 and type 2 diabetes (PRNewswire) - Halozyme announced the initiation of two P2 studies with rHuPH20 in combination with insulin aspart (NovoLog)and insulin lispro (Humalog) enrolling 110 pts;

Diabetes

Isolating Sperm from Cell Mixtures Using Magnetic Beads Coupled with an Anti-PH-20 Antibody for Forensic DNA Analysis. (PubMed) - PLoS One - "Further, our method exhibited greater power and better stability for sperm isolation compared to the traditional differential lysis strategy. Taken together, the anti-PH-20 IMB method described here could be effective for the isolation of sperm needed to obtain a single-sourced DNA profile as an aid to identifying the perpetrator in sexual assault cases."

Journal • Biosimilar

ProMetic Life Sciences and Halozyme sign supply agreement (Trading Markets) - Supply agreement for a proprietary synthetic ligand affinity adsorbent to be used by Halozyme in manufacture of its rHuPH20 product

Supply agreement • Diabetes

Human hyaluronidase provides consistent ultrafast insulin absorption and action over 3 days of continuous subcutaneous infusion (EASD 2012) - Publication-only abstracts: P1, N=36; NCT01275131; Absorption kinetics and insulin action of RAI alone varied considerably with infusion site age; the fraction of insulin exposure occurring within 1 hr following bolus infusion was as little as 15% for a new infusion site and doubled to ~30% after 3 days of use; Both the onset (early tGIR50%) and duration (calculated analogous to Mean Residence Time) of insulin action varied by up to 30 minutes as the infusion site aged

P1 data • Diabetes

Human hyaluronidase + rapid analogue insulin (RAI) improves postprandial glycaemic control in type 2 diabetes compared to insulin lispro alone (EASD 2012) - Publication-only abstracts: P2, N=121; NCT01194258; At the end of treatment, fasting glucose values were similar between treatments (Analog-PH20 6.85±1.47mmol/L vs lispro 7.06±1.49mmol/L; p=0.07); Mean postmeal (90 min) excursions were reduced by 21% (p=0.0001) over the 12 week period with more subjects consistently (at least 2/3 of meals) achieving values <7.8mmol/l at breakfast (56.3% vs 35.7%, p=0.0006) and <7.8mmol/L at all meals (45.2% vs 28.0%, p=0.0007)

P2 data • Diabetes