LifeTide® SW 5

LifeTide® SW 5 is the world’s first and only approved Growth Hormone Releasing Hormone (“GHRH”) DNA therapy for food animals. The product is an injectable DNA plasmid encoding for porcine GHRH, and is administered as a once in a lifetime treatment for use in sows of breeding age to increase the number of piglets weaned. Licensing studies completed in Australia demonstrated a significant decrease in perinatal mortality and morbidity, resulting in an increase in sow productivity and the number of pigs weaned per sow.

LifeTide® SW 5 was approved in Australia in January 2008 by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Further information about this approval is available at http://services.apvma.gov.au/PubcrisWebClient/details.do?view=summary&pcode=59865

Below is the Product Leaflet for LifeTide® SW 5:

Each mL of LifeTide® SW 5 Injectable Plasmid Encoding Porcine GHRH contains 2.5 mg Synthetic Porcine GHRH-encoding plasmid stabilised with 1% w/w Poly-L-Glutamate in sterile water.

INDICATIONS
LifeTide® SW 5 is a once in a lifetime treatment for use in sows of breeding age to increase the number of piglets weaned. LifeTide® SW 5 must only be used by, or under the direction of, a registered veterinary surgeon.

In a field study involving 483 treated sows and gilts and 488 control sows and gilts administration of LifeTide® SW 5 during pregnancy increased the number of piglets weaned by at least 1 piglet per sow over three litters.

To maximize the benefit of LifeTide® SW 5 it should only be used in healthy sows and gilts that are well fed and managed to avoid potentially confounding effects on weaning rates due to inadequate sow nutrition, ill health or poor hygiene.

MODE OF ACTION
The active constituent in LifeTide® SW 5 is a plasmid sequence that typically, after intramuscular injection and electroporation, enters skeletal muscle cells at the injection site and resides within the muscle cell. Treated muscle cells actively produce growth hormone releasing hormone (GHRH) at physiological concentrations. The GHRH, in turn, induces the animal to produce and secrete endogenous growth hormone under the control of normal physiological feedback mechanisms.

The plasmid is delivered to the target tissue, usually a large muscle such as the semimembranosus or sternocranialis, by direct intramuscular injection followed by electroporation. Electroporation increases the efficiency of uptake of DNA into skeletal muscle cells. The manufacturer provides the portable electrokinetic device, CELLECTRA® (VGX™ Animal Health, Inc., The Woodlands, TX, USA). When used as set by the manufacturer, the CELLECTRA® device will deliver the appropriate electroporation conditions.

Administration must be conducted with the pig under short-term, light, general anaesthesia.

DIRECTIONS FOR USE
Restraints:
DO NOT administer any aminoglycoside antibiotic for 7 days after treatment.
TO BE USED by, or under the direction of, a veterinary surgeon as a once in a lifetime treatment in sows under general anaesthesia.

DISCARD UNUSED PRODUCT WITHIN 24 HOURS OF FIRST BROACHING VIAL
Dosage and administration:
The recommended dose of 2mL LifeTide® SW 5 is injected intramuscularly prior to electroporation. Sows/gilts must be under short-term light general anaesthesia during administration and electroporation.

Inject 2mL LifeTide® SW 5 into the muscle using a 3mL syringe and a 21 gauge, 2.0” needle. Using the CELLECTRA® device and a five electrode array electroporator head with the syringe needle inserted through the centre port of the array, apply electroporation according to the manufacturer’s instructions.

Any spilled product should be wiped up with appropriately diluted bleach and disposed of by incineration.

WITHHOLDING PERIOD: MEAT - NIL

TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): ESI not required

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126.

PRESENTATION: LifeTide® SW 5 is available in 10mL PETG multi-dose vials.

STORAGE: Store below -18°C (Deep freeze). Allow to thaw at room temperature immediately before injection. Once thawed, unused vials and syringes may be stored for up to 6 months at 2 to 8°C (Refrigerate). Do not refreeze. After stopper penetration, product must be used within 24 hours.

DISPOSAL: Dispose of empty syringes and plastic containers and any unused product by incineration. Rinse glass vials with bleach and dispose of by wrapping with paper and putting in garbage.

Manufactured by:
VGX™ Animal Health, Inc.
2700 Research Forest Drive #180
The Woodlands, TX 77381 USA

Distributed by:
Redcap Animal Health Pty Ltd
192A Short Street
Birchgrove NSW 2041 AUSTRALIA
Telephone: (02) 9810 3438

APVMA Approval Number: 59865/0108
1. Data on file
2. Published References
a. Khan, A S.; Brown P A,; Draghia-Akli R. (2005) Current Opinion in Molecular Therapeutics. 7(4):306-316
b. Khan A S.; Pope M A.; Draghia-Akli R. (2005) DNA and Cell Biology 24 (12) 810-818
c. Brown P A.; Davis W C.; Draghia-Akli R. (2004) Molecular Therapy 10 (4) 644-651
d. Khan A S. et al (2003). Am J. Physiol Endocrinol Metab 285; E224 – E231