All GLG News Analyses Filed Under: Orthopaedics

Positive and Highly Significant Phase III Results

September 13, 2009

Analysis by: GLG Expert Contributor

Analysis of:Nitec Pharma Reports Positive and Highly Significant Phase III Results From Capra-2 Study of Lodotra(TM) in RA | www.pipelinereview.com

Nitec Pharma, a Switzerland-based specialty pharma company focused on the development and commercialization of medicines to treat chronic inflammation and pain-related diseases, today announced positive results from the second pivotal phase III trial for its lead product, Lodotra.

PHOSPHAGENICS TO COMMENCE PHASE 2/3 TOPICAL DICLOFENAC TRIAL

September 12, 2009

Analysis by: GLG Expert Contributor

Analysis of:PHOSPHAGENICS TO COMMENCE PHASE 2/3 TOPICAL DICLOFENAC TRIAL | www.pipelinereview.com

Progression to the next step of clinical trials for topical NSAID - Diclofenac.

The introduction of the first FDA-approved mobile bearing total ankle replacement system may lead to it becoming the industry standard.

June 10, 2009

Analysis by: GLG Expert Contributor

Analysis of:FDA Approves SBi's S.T.A.R. Total Ankle Replacement System | www.medicalnewstoday.com

While mobile-bearing total ankle replacement systems have a promising track record in Europe, to date all the the FDA-approved total ankle systems in the United States have been fixed-bearing.  This system is the first mobile-bearing device to receive FDA approval.

The Validity of Kyphoplasty

April 29, 2009

Analysis by: GLG Expert Contributor

Analysis of:Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. | linkinghub.elsevier.com.ezproxy.its.uu.se

This article helps validate Kyphoplasty from the European front.  It does not, however, have direct translation from a financial standpoint beacuse there are vast differences in healthcare funding from Eurpo to the US.

One-year results of FREE-study support the use of kyphoplasty in osteoporotic vertebral compression fractures (Kyphon, Medtronic)

April 20, 2009

Analysis by: GLG Expert Contributor

Analysis of:Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. | linkinghub.elsevier.com.ezproxy.its.uu.se

The results of the FREE-study encourage the use of kyphoplasty to stabilize osteoporotic compression fractures, and will have major impact on reimbursement of kyphoplasty in Europe and the rest of the world. Already after 1 month pain (VAS), Quality of Life (EQ5D), and function (SF-36) is significantly improved, if kyphoplasty is used to stabilize osteoporotic vertebral compression fractures, which is pertained during one year followup.

My experience as a Primary Care provider

April 20, 2009

Analysis by: GLG Expert Contributor

Analysis of:Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. | linkinghub.elsevier.com.ezproxy.its.uu.se

We are quite fortunate to have several orthopods who do this procedure at our Yale affiliated teaching hospital.  We have had Grand Rounds on this procedure (intended to "sell" us on the concept) and I have had 2 office details by Reps in the past from Kyphon.  I just had a recent case of a 92 year woman with 2 vertebral fractures who got relief in 2-3 days, but has now had problems with a shifted "X-Stop" device she is scheduled to have removed soon.

Innovation or a quid pro quo?

March 12, 2009

Analysis by: GLG Expert Contributor

Analysis of:Hip deals put money in pocket | www.chicagotribune.com

The link between consultants and industry should not be stifled, lest it choke off innovation.  However, accepting payment to buy loyalty to one product or drug probably goes too far.

The Days of Old or Maybe Not

March 10, 2009

Analysis by: GLG Expert Contributor

Analysis of:Hip deals put money in pocket | www.chicagotribune.com

This article is a liberal attempt to marginalize the changes in Orthopedic protocol.  The practices of each individual physician would need to be analyzed to truly apply these very broad statements.  People fail to give surgeons proper credit for implant selection and their "unspoken" code of ethics.

AZX100: an HSP20 mimic for smooth muscle relaxation in keloid myofibroblasts

February 13, 2009

Analysis by: GLG Expert Contributor

Analysis of:Capstone Therapeutics Announces Initiation of Dosing for AZX100 Phase 2 Clinical Trial in Dermal Scarring; Management to Host Teleconference and Webcast Today | www.msnbc.msn.com

AZX100 from Capstone Therapeutics is a cell-permeable peptide meant to mimic HSP20 and its ability to relax smooth muscle actin, a feature of myofibroblasts in wounds. Keloids form because of a hyper-responsive positive loop of TGFbeta expression. A lack of ability to limit this loop creates a hyper-cellular tissue with high cell/matrix turnover. Tension has been implicated as a factor in myofibroblast physiology and phenotype. The question will be whether release of tension in these cells will be sufficient to advance the process beyond the myofibroblast toward stable repair.

AXX100

February 11, 2009

Analysis by: GLG Expert Contributor

Analysis of:Capstone Therapeutics Announces Initiation of Dosing for AZX100 Phase 2 Clinical Trial in Dermal Scarring; Management to Host Teleconference and Webcast Today | www.msnbc.msn.com

YEARS OF DOING SKIN SURGERY, TREATING KELOIDS IN PATIENTS HAVE DEMONSTRATED A NEED FOR A KELOID PREVENTING MODALITY.  AZX100 SHOULD BE STUDIED, IF IT HAS NOT ALREADY BEEN, IN PATIENTS PRONE TO KEOIDS WHO NEED FURTHER SKIN SURGERY.  THIS GIVE US AN EXCELLENT REPRODUCIBLE CLINICAL MODEL WITH A VISIBLE AND CONTROLLED END POINT.     

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