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GLG News by Physicians who Treat Malignant Melanoma (US)

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Sunil DhawanDecember 13, 2007
Reloxin submission to the FDA
Analysis of: Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA | www.pipelinereview.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
 The submission of Reloxin to the FDA is a positive sign for both Ipsen and Medicis. The market will only grow with the impending approval, and the launch of a competitor to Botox may result in some softening of pricing both to physicians and the end consumer. The two studies that have been done...
Taral PatelDecember 7, 2007
Avastin in breast cancer
Analysis of: F.D.A. Criticizes Avastin Use for Breast Cancer | www.nytimes.com
Author: Taral Patel, Oncologist, Mid Ohio Oncology Hematology Inc.
“On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease. advanced breast cancer who had already tried other drugs. He said he’s never...
Sunil DhawanNovember 26, 2007
NF KappaB decoy technology innovative in inflammatory skin diseases
Analysis of: Meyer Pharmaceuticals Acquires NF-kappaB Decoy Technology For Treatment Of Inflammatory Disease | www.medicalnewstoday.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
Meyer Pharmaceutical acquisition of a NF-kB decoy is interesting in that this would be the first new technology in this area since the topical immunomodulators like Protopic/ Elidel were released. The preliminary work looks good, and phase 2 trials in both atopic dermatitis and psoriasis would be necessary...
Eric WhitmanNovember 22, 2007
New Trial to Treat Metastatic Uveal Melanoma
Analysis of: Hana Biosciences Initiates Marqibo Phase 2 Clinical Trial in Metastatic Malignant Uveal Melanoma | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
Uveal melanoma, although similar histologically to the more common cutaneous melanoma, is virtually a completely different disease. Once metastatic, it has failed to respond to any form of systemic therapy, even those with some (albeit limited) efficacy in "standard" melanoma. Its relative rarity and...
Eric WhitmanNovember 22, 2007
Cytos melanoma vaccine shows promising immuno-responses but has long way to go
Analysis of: Cytos Biotechnology presents encouraging phase IIa study results for its melanoma vaccine CYT004-MelQbG10 | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
This press release discusses Phase IIa results from a novel melanoma vaccine in a small group of patients with various levels of melanoma. Only 22 patients were treated in this study that began about two years ago. Fourteen patients developed specific activation of cytotoxic T cells that recognize...
Eric WhitmanNovember 19, 2007
PARP inhibitor to be tested against triple negative breast cancer in randomized Phase II trial
Analysis of: BiPar Begins Phase 2 Study of Lead PARP Inhibitor in Triple-Negative Breast Cancer Based on Overexpression Biomarker Data | www.pipelinereview.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
This study is interesting because it uses gene expression profile data to choose the tumor target. Specifically, preclinical work looking at PARP expression in various tumor types identified that breast cancers negative for estrogen, progesterone, and HER2 expression were much more likely to overexpress...
Sunil DhawanNovember 19, 2007
CRx-191 - an intriguing combination product
Analysis of: CombinatoRx Announces Initiation of Phase 2a Clinical Study of CRx-191 in Psoriasis | www.pipelinereview.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
CombinatoRx new combination product- CRx-191 is intriguing in that it combines a topical steroid with nortryptiline to minimize the negative effects of the steroid and make it more potent. This would be useful in that higher potency topical steroids are more effective, but cause more thinning of the...
Eric WhitmanNovember 16, 2007
AVAX HNP modified tumor vaccine to undergo Phase III testing in metastatic melanoma
Analysis of: Avax initiates Phase III registration trial for metastasis vaccine | www.therapeuticsdaily.com
Author: Eric Whitman, Medical Director, Office of Grants and Research, Atlantic Health System Inc
M-Vax, an autologous tumor vaccine modified by treatment with HNP, has been proposed as a potential treatment for advanced melanoma. Prior trials that I am aware of were non-randomized and therefore could not be compared to other types of therapy. The majority of the earlier trials were in Stage III...
November 16, 2007
Watch out Tomo....here comes some competition
Analysis of: Varian's New Rapid Arc Delivery | www.varian.com
Author: GLG Expert Contributor
Varian and Elekta's new arc treatments improve workflow, efficiency, and give radiation oncologists a better alternative to tomotherapy.    
Sunil DhawanNovember 12, 2007
Stifel and Allergan collaboration very positive
Analysis of: Stiefel Laboratories, Inc. Enters into Strategic Collaboration with Allergan, Inc. to Expand and Strengthen Dermatologic Product Offering | www.pipelinereview.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The recently announced collaboartion between Stiefel and Allergan in regards to Tazorac is very positive. Stiefel needs this molecule to put into different dosage forms, and in combination with its existing products espoecially Duac, etc. Their current acne product line is strong, but this will solodify...

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