Veloxis Announces Preliminary Analysis of the STRATO Study Suggesting Reduction in Tremor in Kidney Transplant Patients

12/6/2012 8:10 AM EST

Veloxis Pharmaceuticals A/S
Company Announcement

Veloxis Announces Preliminary Analysis of the STRATO Study Suggesting Reduction
in Tremor in Kidney Transplant Patients

Company Announcement no. 24/2012



To: NASDAQ OMX Copenhagen A/S                                                  
     Hørsholm, Denmark, 6 December 2012 



Veloxis Announces Preliminary Analysis of the STRATO Study Suggesting Reduction
in Tremor in Kidney Transplant Patients Switched from Twice-Daily Tacrolimus to
                              Once-Daily LCP-Tacro™



Hørsholm, Denmark, December 6, 2012 – Veloxis Pharmaceuticals A/S (OMX: VELO)
today announced results of a preliminary analysis from the first 16 patients in
its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO
(STRATO) clinical trial. Results from the first 16 patients demonstrated a
trend toward a reduction in tremor following the switch from twice-daily
tacrolimus to once-daily LCP-Tacro. 

“Tremor is a common side effect of tacrolimus administration and it can
significantly affect quality of life for transplant patients,” said Anthony
Langone, M.D., Associate Professor at Vanderbilt University and Medical
Director of Renal Transplantation, Nashville Veteran Affairs Hospital.  “It
would be a significant help for patients to have options for managing this
troublesome side effect and potentially LCP-Tacro may be of benefit.” 

William Polvino, chief executive officer of Veloxis said, “We are encouraged by
these promising results from our preliminary analysis. These early findings
suggest that key measures of tremor may be improved in stable kidney transplant
patients converted from standard twice-daily tacrolimus to once-daily
LCP-Tacro.  We are now looking forward to completing enrollment of the full
cohort in 2013.” 

In the open-label STRATO trial, kidney transplant patients who were stable on
twice-daily tacrolimus and had a complaint of tremor were switched to
once-daily LCP-Tacro. Tremor was evaluated by independent neurologists, pre and
post conversion to LCP-Tacro, using the Fahn-Tolosa-Marin tremor rating scale
(FTM-TRS), the Tremorometer™, an accelerometry instrument that measures
frequency and amplitude of tremor and by PGI (Patient Global Impression of
Change), a validated 7-point scale to assess change in amount of tremor
reported by patients. 

The primary endpoint of the trial is the mean change from baseline in the FTM
tremor rating scale for overall tremor score 7 days after LCP-Tacro conversion.
The preliminary analysis of available data on 16 subjects showed improvement in
FTM rating scales, reduction in tremor amplitude by tremorometer recordings and
PGI rating improvements. 

The study continues to enroll and final data is expected in first half of 2013.
 The interim study results will be submitted for presentation at upcoming
scientific meetings. 



For more information, please contact:



Veloxis Pharmaceuticals A/S



John Weinberg, M.D.

EVP, Chief Commercial Officer

Veloxis Pharmaceuticals

Mobile +1 (908) 304-3389

Email  



About LCP-Tacro™ and tacrolimus

Tacrolimus is a leading immunosuppression drug used for the prevention of
transplant allograft rejection after organ transplantation. LCP-Tacro™ is an
investigational drug that is being developed as a once-daily tablet version of
tacrolimus, with improved bioavailability, consistent pharmacokinetic
performance and reduced peak-to-trough variability when compared to currently
approved tacrolimus products. Transplant patients need to maintain a minimum
blood level of tacrolimus for the prevention of transplant allograft rejection,
but excessive levels may increase the risk of serious side effects such as
nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic
infections. Therefore, tacrolimus levels need to be managed carefully, and
transplant patients are typically obliged to make frequent visits to the
hospital for monitoring and dose adjustments after receiving a new organ. 



About Veloxis Pharmaceuticals

Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis
Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The
company’s lead product candidate is LCP-Tacro™ for immunosuppression,
specifically organ transplantation. Veloxis’ unique, patented delivery
technology, MeltDose®, can improve absorption and bioavailability at low-scale
up costs.  Veloxis has a lipid lowering product, Fenoglide®, currently on the
U.S. market that is commercialized through partner Santarus, Inc. Veloxis is
listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO. 



For further information, please visit www.veloxis.com.