All GLG News Analyses Filed Under: Oncology

Donald FlemingDivision Head of Hematology and OncologyDAVIS HEALTH SYSTEM INC

Omapro will fill a CML void

November 14, 2009

Analysis of:US FDA accepts ChemGenex's Omapro NDA filing to treat CML, grants priority review status | www.pharmabiz.com

Patients with CML have a good prognosis when treated with TKI's An exception is the ones that develope a particular mutation known as T315IOnly SCT seems to be effective in this group of patients and maybe too morbid of therapy for many patients

Eric WhitmanMedical Director, Office of Grants and ResearchATLANTIC HEALTH SYSTEM INC

Synta Drug for Metastatic Melanoma Not Dead Yet (?)

November 3, 2009

Analysis of:Synta Pharmaceuticals Announces Updated Elesclomol SYMMETRYSM Data Presented at Melanoma XIII | www.businesswire.com

Updated data presented at an annual Melanoma conference suggests the drug Elesclomol may benefit a subset of patients treated on a Phase III trial. This Synta Pharmaceuticals-sponsored trial in metastatic melanoma patients was stopped for safety (survival) concerns in February 2009, but the updated analysis suggests that a commonly available biomarker may identify patients who appear to benefit from Elesclomol treatment.This news is important because it may allow Synta to continue to pursue approval for Elesclomol in either melanoma patients or in other cancers. They will report an updated survival analysis twelve months after the protocol was stopped, after February 2010. Further info from Synta is expected soon.

Eric WhitmanMedical Director, Office of Grants and ResearchATLANTIC HEALTH SYSTEM INC

Delcath Phase III trial for metastatic melanoma completes enrollment

November 3, 2009

Analysis of:Delcath Systems, Inc. Completes Phase III Study Enrollment | www.reuters.com

The Delcath Systems Percutaneous Hepatic Perfusion (PHP) trial to treat patients with metastatic melanoma has completed enrollment and now must track patients, record data, and analyze results.This trial was apparently enrolled on schedule and the company is targeting 2010 for FDA regulatory submission.

Jon StrasserAssistant Professor of Radiation OncologyTHOMAS JEFFERSON UNIVERSITY

Particle Beam Technology - Costly and a limited utility

October 26, 2009

Analysis of:Particle Beam Radiation Therapy published by AHRQ | effectivehealthcare.ahrq.gov

Over the last several years, there has been an increased interest in the US in particle beam therapy as the costs have come down and large manufacturers have become more efficient in installing these centers. In addition, private companies have made a business model of building proton centers - mostly by treating prostate cancer.Protons are incredibly useful in specific diseases - ie ocular melanoma, pediatric cancers, but are too costly without proven benefit for our health care system.

Particle Beam Radiation Therapy (PBRT) life saving technology but who will pay?

October 22, 2009

Analysis by: GLG Expert Contributor

Analysis of:Particle Beam Radiation Therapy published by AHRQ | effectivehealthcare.ahrq.gov

PBRT is an exciting technology that has emerged as a life saver for children and many adults with head/neck , eye and other difficult to treat cancers. Proton Centers require massive investments from $100-250 million. Payor groups from Medicare to commercial plans are faced with whether to pay for this promising technology and what diagnoses are appropriate. This study looks at the effectiveness of PBRT vs. IMRT and other current treatment options. But can centers have an ROI on uncommon cancer?

Eric WhitmanMedical Director, Office of Grants and ResearchATLANTIC HEALTH SYSTEM INC

Plexxikon Drug for Melanoma Continues to Show Great Promise

October 14, 2009

Analysis of:Researchers herald 'breakthrough' skin cancer therapy | www.fiercebiotech.com

The new drug PLX-4032, being developed by Plexxikon and Roche, continues to show impressive short term results in melanoma patients with specific BRAF mutations, with a reported 70% tumor response rate.

Donald FlemingDivision Head of Hematology and OncologyDAVIS HEALTH SYSTEM INC

Triple negative Breast Cancer Strategies

October 14, 2009

Analysis of:MediGene completes patient recruitment into EndoTAGTM-1 phase II breast cancer trial | www.pharmabiz.com

Triple negative Breast cancer has been a phenotype with little hope up until recentlyWhile advances in hormonal therapy and Her2 blocking agents has revolutionized ER/PR + and Her 2 positive breast cancer therapy, triple negative breast cancer pulls down the outcomes, with similar responses as for non small cell lung cancer

Expanding Treatment Options for Prostate Cancer

October 11, 2009

Analysis by: GLG Expert Contributor

Analysis of:Medicare to cover controversial prostate treatment | www.philly.com

1. Medicare now covers Cyberknife radiosurgery treatment for prostate cancer in most parts of the United States.2. The Cyberknife has specific advantages over conventional surgery and conventional radiotherapy/IMRT for prostate cancer.3. Early clinical results on the use of Cyberknife radiosurgery for prostate cancer have been very favorable, with high rates of tumor control and minimal side effects.

Death due to HPV vaccine....NOT

October 2, 2009

Analysis by: GLG Expert Contributor

Analysis of:GSK recalls Cervarix batch after reports of death due to cervical cancer vaccination in UK | www.pharmabiz.com

Today's news was that patient who reportedly died 2 hours after an HPV vaccine had a tumor in her chest and died of that cause. The vaccine was circumstantial.

Researchers herald 'breakthrough' skin cancer therapy

September 27, 2009

Analysis by: GLG Expert Contributor

Analysis of:Researchers herald 'breakthrough' skin cancer therapy | www.fiercebiotech.com

Plexxikon's early stage experimental melanoma drug PLX4032 looks like a "major breakthrough," says one leading researcher after reviewing new data from a small trial.

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