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All News Analyses by this Author

Denosumab May Help to Salvage Bone Health in Metastatic Disease

April 13, 2009

Analysis of:Randomized Phase II Trial Of Denosumab In Patients With Bone Metastases From Prostate Cancer, Or Other Neoplasms After Intravenous Bisphosphonates | www.medicalnewstoday.com

Metastatic spread to the bone is a common and problematic complication for many patients with advanced cancer.  Current treatment with bisphosphonates only modestly controls skeletal spread. This study suggests that the monoclonal antibody Denosumab has biologic and clinical activity to help patients who are at risk for further bone metastases despite bisphosphonate therapy.

Enrollment in Poniard's Phase III Study of Picoplatin is Complete

March 29, 2009

Analysis of:PipelineReview.com - Biotech News | www.pipelinereview.com

Small Cell lung cancer is tough to treat, especially when it recurs after prior therapy, and treatment options are limited.  Picoplatin is a new-generation platinum chemotherapy, and is being studied by Poniard Pharmaceuticals (PARD) in a randomized, 400-patient, phase III study.

Epo in Myeloma: A good Idea. Will the Data Bear it Out?

March 23, 2009

Analysis of:XTL Biopharmaceuticals Announces the Acquisition of the Use Patent on Recombinant Erythropoietin (rHuEPO) for the Treatment of Multiple Myeloma | www.pipelinereview.com

Anemia is a big problem for many Myeloma patients.  Recombinant Epo has been used to treat many different anemias, but its use has been severely restricted over the past few years due to reports of clotting complications and inadvertent tumor growth.  Through an asset purchase agreement, XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB; TASE: XTL) has agreed with Bio-GAL to acquire the "use patent" for Epo in the treatment of anemia in myeloma.  

Herceptin for Gastric Cancer? Roche Says, "Yes!"

March 19, 2009

Analysis of:UPDATE 1-Roche's Herceptin prolongs stomach cancer survival | www.reuters.com

Herceptin is an established biologic drug with proven efficacy in some -about 20% - breast cancer tumors.  The teaser for this study suggests that Herceptin + chemo "significantly" prolongs survival compared to chemo alone for advanced gastric cancer. 

Blinatumomab for Leukemia & Lymphoma; MedImmune Hands it Back to Micromet

March 16, 2009

Analysis of:MedImmune returns cancer drug rights to Micromet | www.forbes.com

Blinatumomab (MT103/MEDI-538) has a complicated and unique mechanism of action.  While still in clinical trials, results have been promising, and it represent a potential novel direction for the treatment of some lymphomas and leukemias.  MedImmune, which had been helping to co-promote and develop the drug, has returned all of its license rights back to Micromet.

Transdermal Patch with AGI-004 Reduces Chemo-Induced Diarrhea (CID)

March 16, 2009

Analysis of:Positive Phase II AGI-004 proof of concept study | www.msnbc.msn.com

In addition to dimishing quality of life, Chemotherpy-Induced Diarrhea (CID) can reduce our ability to administer full doses of potentially effective tretaments, and can occasionally lead to life-threatening complications.  AGI-004 was studied in the form of a skin patch, and when compared to placebo, diminished frequency and intensity of CID.

Wal-Mart to Try its Hand at Selling EMR Systems

March 13, 2009

Analysis of:Wal-Mart Plans to Market System for Digital Health Records - NYTimes.com | www.nytimes.com

Electronic Medical Records (EMRs) can potentially make a medical practice more efficent and successful.  However, there are numerous obstacles, including high cost of inital purchase and annual maintenance, as well as concerns about compatibility with other systems.  Despite these and other issues, the future of medicine seems destined to be rely on EMRs in one capacity or another.  Wal-Mart is poised to sell a specific EMR system through its Sam's Club chain.

Lipocalin2 (LCN2): Another Potential Marker of Breast Cancer Spread

March 11, 2009

Analysis of:Urine test may tell of breast cancer's spread | www.reuters.com

Early detection of breast cancer - or even demonstrating its spread earlier rather than later - remains one of Holy Grails of molecular medicine.  This reports suggests that measuring Lipocalin2 (LCN2) from urine may be able to aide in the early diagnosis of breast cancer.

Rituximab Approved for CLL in Europe

March 10, 2009

Analysis of:MabThera approved in the EU for patients with chronic lymphocytic leukaemia | www.pipelinereview.com

CLL is a very common low-grade malignancy, and although most patients with CLL don't need therapy, many do.  Rituximab is a biologic therapy 'Home Run' and has already been proven to be safe and effective treating a variety of lymphomas, including low-grade.  This large randomized study allowed for EU approval of Rituxan in combination with chemo.

More of the Same Crackdown on Amgen's Epo Agents

August 1, 2008

Analysis of:Amgen Told to Reword Drug Label | www.nytimes.com

The FDA used new power to order Amgen to change its product label for its Epo Stimulating Agents (ESAs).  The new label will reflect what Medicare reimbursement guidelines have recently oulined.

Molecular Profiling for Epo Stimulating Agents: Trying to 'Stop the Bleeding'

June 24, 2008

Analysis of:New Study Probes Safety of Erythropoiesis-Stimulating Agents | www.medscape.com

Use of Epo Stimulating Agents (ESAs) for cancer patients have all but come to a screeching halt when a plattoon of studies came out suggesting that ESAs might actually cause more harm, notably by possibly acting as a growth factor for tumor cells.  Now, reserachers are trying to determine which tumors are more likely to use ESAs to grow, in order to identify other patients in whom it might be 'safer'.

Transgene's TG4010 Vaccine for Lung Ca - Add it to the List...

June 6, 2008

Analysis of:Transgene's Therapeutic Vaccine TG4010 Meets Primary Endpoint in Non-Small Cell Lung Cancer Phase IIb Trial | www.pipelinereview.com

Transgene's TG4010 vaccine has a fairy elegant two-gene design.  It appears to add benefit to a standard chemo regimen in this good-sized, randomized Phase II study for advanced lung cancer.  More mature survival data will be ready by year's end.  Phase III study is being planned.  

Antisoma's ASA404: Another Anti-Angiogenesis Agent to Watch

June 4, 2008

Analysis of:Positive data on Antisoma’s ASA404 presented at ASCO | www.pipelinereview.com

Adding novel biologic agents (such as ASA404) to traditional chemotherapy is a very hot trend in cancer research.  The data from Antisoma's lung cancer study are certainly intriguing, but again, phase II, and retrospective. 

Genentech’s Avastin Appears Safe in Early Colon Cancer

June 3, 2008

Analysis of:Initial safety report of NSABP C-08, a randomized phase III study of modified 5-fluorouracil (5-FU)/leucovorin (LCV) and oxaliplatin (OX) (mFOLFOX6) with or without bevacizumab (bev) in the adjuvant treatment of patients with stage II/III colon cancer. | www.abstract.asco.org

While chemo plus Avastin is the standard of care for first treatment of advanced colon cancer, chemotherapy alone is used for most early colon cancer. This large study demonstrates the relative safety of adding Avastin to chemo in the early - adjuvant – setting.

Continuing Genentech's Herceptin - Confirming What We Suspected

June 3, 2008

Analysis of:Continuing Herceptin treatment prevents disease progression in women with aggressive metastatic breast cancer | www.pipelinereview.com

Many of us oncologists have been in the practice of continuing  Herceptin (Trastuzumab) even when the breast cancer we were treating was growing while on the drug.  Now, this randomized study gives data to back up that practice.

Can Glaxo’s Affymetrix Microarray Predict Who Will Benefit from its MAGE-A3 Immunotherapy?

June 2, 2008

Analysis of:New data on MAGE-A3 cancer immuno therapy support novel options of treating non-small cell lung cancer and melanoma | www.pipelinereview.com

This describes a potential two-step process using modern molecular biology to customize cancer therapy. First the Affymetrix Microarray analyzes tumor genes to try to identify which patients are at high risk to have a cancer recurrence following lung cancer surgery. Second, Glaxo's MAGE-A3 proprietary immunotherapy system is administered to those high risk patients to try to reduce their risk for relapse.  So far, the phase II data and its retrospective molecular analysis are intriguing.

Glaxo's Promacta Hits a Snag with the FDA

May 29, 2008

Analysis of:FDA says Glaxo drug fails to control bleeding | seattletimes.nwsource.com

Apparently, the FDA was not impressed enough with the data for Promacta (eltrombopag) for the treatment of ITP, a common and potentially serious auto-immune bleeding disorder involving platelets.  Citing a lack of "robust evidence" from several studies, the FDA will be seeking further opinions from an 'outside panel of experts'.

Can NOV-002 from Novelos Therapeutics Break into Therapy for Breast, Lung,or Ovarian Cancers?

May 14, 2008

Analysis of:Novelos Therapeutics announces positive results in ongoing phase 2 neoadjuvant breast cancer trial as Musc Hollings Cancer Center | www.pipelinereview.com

The positive interim results released by Novelos Therapeutics about its chemoprotectant / chemopotentiator NOV-002 were not very meaty: Divining the true implications of pathologic CRs in neo-adjuvant breast cancer can be tricky.  Plus, this was a open label, phase II study, and the number of patients reported is really rather small. So, while the positive results are interesting, they are not (yet) supported by robust clinical or statistical evidence.

BioSimilar G-CSF Might be Coming: How Will it Stack up to Neupogen?

May 12, 2008

Analysis of:Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market | www.pipelinereview.com

Now that liquid Leukine (GM-CSF) has been withdrawn by Bayer, Amgen commands the North American G-CSF market with its Neupogen and Neulasta.  However, Indian manufacturer INTAS Biopharmaceuticals Ltd. (IBPL) has been treating patients with a biosimilar G-CSF called Neukine since 2004.  And while Kwizda Pharma of Austria had been working with IBPL to develop G-CSF for Europe, recently Kwizda Pharma transferred its development rights to Apotex Inc. of Canada, to develop the drug for Europe and North America (http://www.pipelinereview.com/content/view/19388/118/).  Of note, in July, 2007, Abraxis BioScience and India’s Biocon Limited announced a licensing agreement for a biosimilar G-CSF in North America and the European Union (http://www.genengnews.com/news/bnitem.aspx?name=20522839). .

New Proteosome Inhibitor Carfilzomib Ready for Another Phase II Study

May 6, 2008

Analysis of:Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients with Relapsed Solid Tumors | www.pipelinereview.com

The data from this phase Ib study will allow Proteolix to proceed with a phase II study of their novel proteasome inhibitor Carfilzomib in patients with advanced solid tumors.  Phase II studies are already underway investigating its activity in myeloma, the tumor type shown to be sensitive to proteasome inhibition.

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