Dr. Donald Tsai MD, PhD

GLG News^SM Analyses by Donald Tsai

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BiovaxID: Does It Work?

August 15, 2008

Analysis of:Biovest Reports Results for Patients Treated with Anti-Cancer Vaccine: BiovaxID(R) Demonstrates Clinically and Statistically Significant Improvement of Disease-Free Survival in Non-Hodgkin's Lymphoma in Pivotal Phase 3 Clinical Trial | biz.yahoo.com

1) BiovaxID shows a 100% improvement in DFS at 3 years (p=0.24) 2) BiovaxID shows an improvement in median overall DFS with a significant P value (p=0.047) 2) This is the first lymphoma vaccine with a suggestion of activity. 3) BiovaxID shows evidence of activity despite the failure of 2 other lymphoma vaccines made by Genitiope and Favrille.

Rapidly Growing Initial Sales of Revlimid

April 28, 2006

Analysis of:Celgene Corporation Reports Record Revenue and Operating Profits | biz.yahoo.com

Revlimid is off to a good start as far as sales go for myelodysplastic syndrome.  Sales should get even better when Revlimid gets its indication for multiple myeloma in June.  The billion dollar question is what then?  Will Revlimid continue to grow and add further indications?  Will Revlimid replace thalidomide (thus reducing sales growth for Celgene as it trades one drug for another)?

New Anti-CD 22 Antibody Therapy for Lupus

April 27, 2006

Analysis of:Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus | arthritis-research.com

Rituxan is rapidly evolving into a standard therapy for many autoimmune diseases (ITP, hemolytic anemia, rheumatoid arthritis, lupus etc). However, there is nothing magic about Rituxan.  It is simply an antibody that depletes B cells by binding to CD20, a marker present on mature B cells.  It is likely that with time, other new and better antibodies will appear to challenge Rituxan. 

This abstract describes the first use of epratuzumab (humanized anti-CD22 monoclonal antibody) in the treatment of Systemic Lupus Erythematosus.  The drug achieved a 100% response rate in a small phase II pilot trial.  While a small trial, it suggests epratuzumab may be a safe and effective treatment for Lupus.

Will Velcade be First Line Therapy for Multiple Myeloma? Sort of Maybe..

April 26, 2006

Analysis of:A Phase I Trial of Lenalidomide with Bortezomib in Relapsed and Refractory Multiple Myeloma | www.abstracts2view.com

Thalidomide is currently first line therapy for multiple myeloma.  Revlimid is a new agent similar to thalidomide that has shown significant activity and a better side effect profile than thalidomide.  There is much speculation that Revlimid may ultimately replace thalidomide in first line and other line use.  Velcade is currently used mostly in relapsed multiple myeloma.  The general feeling is that Velcade may be in trouble with Revlimid competition coming.  With an improved more powerful competitor coming, Velcade's trend can only be downward......right?   This article suggests Velcade may yet slip into first line and other use by riding the Revlimid wave rather than fighting it.

Other New Uses for Revlimid

April 18, 2006

Analysis of:Lenalidomide Treatment for Anemia Associated with Myelofibrosis with Myeloid Metaplasia | www.abstracts2view.com

Revlimid (lenalidomide) has been FDA approved for the treatment of myelodysplastic syndrome.  It clearly also has activity in multiple myeloma.  It is very likely to get an indication for multiple myeloma in the very near future.  The question is what then? Is that it or are there potential other indications.....

This article ( www.abstracts2view.com/hem_ash05atlanta/view.php?nu=HEM05L1_414&terms= ) suggests there are other potential uses for Revlimid, such as myelofibrosis.

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