Breaking News

Tweet TWEET

BTG PLC BTG Phase III trials of Varisolve PEM presented at ACP

  BTG PLC (BTG) - Phase III trials of Varisolve PEM presented at ACP

RNS Number : 3955R
BTG PLC
19 November 2012




Full data from pivotal  Phase III trials of  Varisolve^® PEM presented at  the 
26^th Annual Congress of the American College of Phlebology



London, UK, 19 November  2012: BTG plc (LSE:  BTG), the specialist  healthcare 
company, today announces that full data from VANISH-1 and VANISH-2, the two US
pivotal Phase  III  trials of  polidocanol  endovenous microfoam  (PEM),  were 
presented at the 26^th Annual Congress  of the American College of  Phlebology 
in Hollywood, Florida, USA on 16 November 2012.



PEM is in development for  patients with saphenofemoral junction  incompetence 
and symptomatic and/or visible varicose  veins. VANISH-1 and VANISH-2 had  the 
same  endpoints  and   all  primary  (improvement   in  symptoms),   secondary 
(improvement in  appearance) and  tertiary (duplex  response, venous  clinical 
severity score (VCSS)  and VEINES-QOL questionnaire)  endpoints were met  with 
all therapeutic PEM concentrations compared to  placebo with a high degree  of 
statistical significance (p < 0.0001).



In the  first presentation,  Kenneth Todd,  MD, a  Principal Investigator  for 
VANISH-2 and an American College of Phlebology Committee Member from the South
East Vein and  Laser Center,  described the results  of VANISH-2  in his  talk 
entitled: 'A Phase III study to investigate the efficacy and safety of PEM  on 
the symptoms of varicose veins'.



Dr. Todd  noted that  80%  of patients  treated with  PEM  0.5% or  1.0%  dose 
concentrations reported  a  much  or  moderate  improvement  of  symptoms,  as 
measured with  the novel  VVSymQ™ patient  reported outcome  (PRO)  instrument 
compared to 20% in the placebo arm. In addition, 85% of patients  demonstrated 
elimination of saphenofemoral  junction reflux and/or  occlusion of the  great 
saphenous vein and  all incompetent  veins, as measured  by duplex  ultrasound 
compared with 2% in the placebo arm. Dr. Todd concluded that PEM treatment  of 
the great saphenous vein (GSV)  system has demonstrated efficacy in  improving 
symptoms in patients with varicose veins.



Patients treated in this study were representative of a typical varicose veins
population, with an age range of 21 to 73 and baseline GSV diameter range of 3
mm to 19  mm. In  this trial,  where patients could  have received  up to  two 
blinded treatments to treat  the entire GSV  system and visible  varicosities, 
patients treated with PEM 1.0% received an average of 1.4 blinded treatments.



Side effects  were mostly  mild or  moderate. There  were no  serious  adverse 
events or cerebrovascular events attributable  to PEM treatment. No  pulmonary 
emboli were  reported.  The  most  common adverse  events  were  expected  and 
included retained coagulum, pain andsuperficial thrombophlebitis.



Out of 230 PEM-treated patients, 6 experienced proximal and 7 distal deep vein
thrombosis; other venous thrombi occurred as extensions from the GSV into  the 
common femoral vein (9), and isolated calf vein thrombi (2). All thrombi  were 
small and most (77%)  were asymptomatic, and all  resolved or stabilized in  a 
median time of 29  days; half of the  cases were treated with  anticoagulation 
per the discretion of the physician.



In the secondpresentation, Ted  King, MD, one  of the Principal  Investigators 
for VANISH-1 and the National Medical Director of the Vein Clinics of America,
described the results of VANISH-1 in a talk entitled: 'Phase III study of  PEM 
on the appearance of varicose veins'.



Dr. King focused on the improvement  in appearance as measured by the  patient 
self-assessment PRO tool, PA-V^3,  and by an  independent physician review  of 
before and  after  photos in  a  blinded  setting using  a  clinical  reported 
instrument,  IPR-V^3.  64%   of  patients   treated  with   active  PEM   dose 
concentrations (PEM  0.5%,  1.0%  and  2.0%) reported  a  much  or  moderately 
improved appearance eight weeks after treatment compared to 4% in the  placebo 
arm. 79% of treatments resulted in a much or moderately improved appearance as
measured by physicians  using the  IPR-V^3toolcompared to 9%  in the  placebo 
arm.



Dr. King concluded that  PEM demonstrated efficacy  in achieving a  clinically 
meaningful improvement  in the  appearance of  legs in  patients with  chronic 
venous insufficiency  and superficial  varicose veins  in a  single  treatment 
session from both a patient  perspective and independent physician review.  He 
noted  that  a   single  treatment  demonstrates   increasing  efficacy   with 
increasingconcentration and that efficacy was  similar between PEM 1% and  2%. 
Patients treated in this study were representative of a typical varicose veins
population. Only  one  blinded treatment  per  patient was  permitted  in  the 
VANISH-1 trial.



The safety profile was consistent with  that seen in VANISH-2: adverse  events 
were mostly mild or moderate and there  was a modest increase in side  effects 
as dose concentration  increased. The  most common adverse  events were  pain, 
superficial thrombophlebitis, injection  site haematoma  and limb  discomfort. 
Out of 275 PEM-treated patients 5 experienced proximal and 4 distal deep  vein 
thrombosis; other venous thrombi occurred as extensions from the GSV into  the 
common femoral  vein (15)  and  isolated calf  vein  thrombi (3).  All  venous 
thrombi resolved or  stabilized; there  were no reported  pulmonary emboli  or 
recurrent thrombi.



Dr. Todd commented: "Current treatments for patients with medically-important,
symptomatic varicose veins are time-consuming for both patients and physicians
and do  not offer  a  comprehensive treatment.  The  publication of  the  full 
results for  VANISH-1  and  VANISH-2  confirm  the  top-line  results  already 
reported and  demonstrate that  PEM, if  approved, could  offer an  effective, 
comprehensive treatment option for patients with symptomatic varicose veins."



Notes

PEM is a patent-protected  experimental drug/device combination product  which 
produces  an  engineered  polidocanol  endovenous  microfoam  manufactured  in 
accordance with GMP  standards. PEM is  delivered from a  canister through  a 
syringe into  the  incompetent  vein  under  ultrasound  guidance.  PEM  first 
displaces blood and then the  polidocanol chemically ablates the inner  lining 
of the vein wall, causing the vein to close. A compression bandage is  applied 
to the leg for a period of approximately two weeks.





For further information please contact:



BTG                                             FTI Consulting
Andy Burrows, Director of Investor Relations    Ben Atwell
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605 +44 (0)20 7831 3113
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000



About BTG

BTG is an international specialist  healthcare company that is developing  and 
commercialising products targeting critical care, cancer and other  disorders. 
The company has diversified revenues from  sales of its own marketed  products 
and from  royalties on  partnered  products, and  is  seeking to  acquire  new 
programmes and products to  develop and market  to specialist physicians.  For 
further information about BTG please visit our website at www.btgplc.com.





                     This information is provided by RNS
           The company news service from the London Stock Exchange

END


MSCGMMMMFRNGZZZ -0- Nov/19/2012 07:00 GMT