|ASCO updates: Bristol Myers skin cancer drug prolongs survival.|
|By BioMedReports.com Staff|
|Friday, 04 June 2010 18:47|
Below is a list of the companies that made news in the healthcare sector on Friday-Sunday, June 4-6, 2010.
Bristol-Myers Squibb Company (NYSE: BMY) announced positive results Saturday from a Phase 3 randomized, double blind study of ipilimumab which demonstrated that overall survival was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab. The results were statistically significant for patients receiving ipilimumab alone or ipilimumab in combination with a gp100 peptide vaccine ratio when compared to those patients who received the control therapy of gp100 alone. Forty-four to 46 percent of patients treated with ipilimumab were alive at one year compared to 25 percent of patients treated with the control arm. At two years, 22 to 24 percent of patients treated with ipilimumab were alive compared to 14 percent of patients treated with the control arm.
As in other studies of ipilimumab, the most common side effects reported in the study were immune-related and based on the mechanism of action. These immune-related adverse events were sometimes severe and life-threatening, and most often affected the gastrointestinal, skin, liver, or endocrine systems.
"Results from this ipilimumab study are exciting and show the potential of harnessing the immune system to treat cancers like metastatic melanoma," said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School.
Sunday news releases from ASCO:
Amgen (Nasdaq:AMGN) announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer. AMG 386 is a first-in-class investigational peptibody that is designed to block angiogenesis by inhibiting angiopoietin-1 and -2 (Ang1 and Ang2). Angiopoietins interact with the Tie2 receptor, which mediates vascular remodeling. Ang1 and Ang2 are thought to play opposing roles, and the maturation of blood vessels appears to be controlled by their precise balance.
"The reality of ovarian cancer is that 80 percent of women diagnosed in later stages will experience recurrence, often multiple times, and eventually die from the disease," said Beth Karlan, M.D., director of the Women's Cancer Research Institute at Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute and director of Cedars-Sinai Medical Center's Division of Gynecologic Oncology. "In this study, AMG 386 showed promising antitumor activity and extended progression-free survival."
Celgene International Sàrl (NASDAQ: CELG) today announced that data from a National Cancer Institute-sponsored clinical study were presented by representatives of a network of researchers led by the Cancer and Leukemia Group B (CALGB) at the annual meeting of the American Society of Clinical Oncology.
Results of the Phase III, randomized, controlled, double-blind, multi-center clinical study of patients newly diagnosed with multiple myeloma following an autologous stem cell transplant (ASCT) (CALGB 100104) demonstrated that 13.8% of patients (29/210) receiving continuous daily treatment with lenalidomide (REVLIMID) 10-15 mg had their disease progress at a median follow-up of 12 months compared to 27.9% (58/208) (p<0.0001) for patients that received placebo. This represented a 58% reduction in risk of disease progression for patients receiving lenalidomide.
In a separate announcement Sunday Celgene reported clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd).
Exelixis, Inc. (Nasdaq: EXEL) today reported updated interim data from three ongoing trials of XL765 (SAR245409), an orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K) and mTOR. Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The pathway also has been implicated as a mediator of resistance to agents targeting epidermal growth factor receptor (EGFR) family members. Exelixis is developing XL765 with sanofi-aventis.
"XL765 has unique clinical potential because it inhibits the signaling of both PI3K and mTOR, two important nodes in this critical pathway," said Michael M. Morrissey, Ph.D., president of research and development at Exelixis. "PI3K signaling is dysregulated in a broad spectrum of human cancers, and mTOR is a well validated target for cancer therapy. The results from these studies suggest that this novel compound may have clinical activity as a single agent and in combination with targeted agents and chemotherapy. These data support the ongoing broad phase 1/2 clinical program and further phase 2 evaluation that sanofi-aventis and Exelixis have planned for XL765."
Genta Incorporated (OTCBB: GETA) announced the presentation of combined data on early endpoints from the Company’s randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma. The presentation included a "pooled analysis" that assessed combined efficacy results for the endpoints of overall response and progression-free survival from both studies.
Incyte Corporation (Nasdaq:INCY) announced additional positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 66 patients with HER2-positive metastatic breast cancer during a poster session at the American Society of Clinical Oncology
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it presented updated safety and clinical activity data from the FALCON trial, a randomized, controlled Phase 2 study of ZYBRESTAT(TM) (CA4P) in patients with non-small cell lung cancer (NSCLC), at the 2010 Annual Meeting of the American Society of Clinical Oncology. The updated analysis showed that meaningful improvements were observed in response rate, progression-free survival and overall survival rates in the study arm (ZYBRESTAT combined with bevacizumab and carboplatin/paclitaxel chemotherapy) as compared with the control arm (bevacizumab and chemotherapy) of the trial. The combination regimen including ZYBRESTAT was observed to be well-tolerated with no significant cumulative toxicities when compared with the control arm of the study.
Saturday news from ASCO:
Abraxis BioScience, Inc. (NASDAQ:ABII) announced today that findings from their phase 3 randomized trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) plus carboplatin, showed a statistically significant 31 percent improvement in overall response rate (ORR) when compared with Taxol® (paclitaxel) injection plus carboplatin in the first-line treatment of patients with non-small cell lung cancer (NSCLC). Patients in the ABRAXANE arm demonstrated an ORR of 33 percent compared with those receiving Taxol, with an ORR of 25 percent, as assessed by independent radiologic review using RECIST criteria. This difference met statistical significance at p=0.005 and achieved the primary end point agreed to with the FDA in a Special Protocol Assessment. In addition, analysis of the highly difficult-to-treat subset of squamous cell carcinoma, showed a 67 percent improvement (p<0.001) in those who received the ABRAXANE combination versus those who received the Taxol combination.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has initiated a Phase 2 clinical trial evaluating SCH 900105 (also referred to as AV-299) for the treatment of non-small cell lung cancer. The initiation of this trial triggers an $8.5 million milestone payment by Merck to AVEO resulting from a 2007 agreement between AVEO and Schering-Plough (now Merck). In addition, AVEO announced the presentation of results of a Phase 1 safety and tolerability trial of SCH 900105, an investigational antibody targeting hepatocyte growth factor/scatter factor (HGF/SF), at the 46th Annual Meeting of the American Society of Clinical Oncology.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced that mature results from a Phase 1/2 study evaluating CDX-011 in advanced stage breast cancer patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology. CDX-011 is an experimental antibody-drug conjugate (ADC) directed against glycoprotein NMB (GPNMB) and linked to a potent cancer cell-killing drug, monomethyl-auristatin E (MMAE).
Mature data from this study of CDX-011 show a progression free survival (PFS) rate at 12 weeks of 35% of patients, which is a positive outcome for a heavily treated advanced breast cancer population with very limited treatment options. "The results in triple negative disease are especially encouraging," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "A subset analysis using a newly optimized diagnostic assay for GPNMB showed that patients with strong stromal or tumor cell expression of GPNMB may be most likely to respond to CDX-011."
Seattle Genetics, Inc. (Nasdaq:SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today reported data on Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) patients retreated with single-agent brentuximab vedotin (SGN-35). Preliminary data demonstrate that objective responses were achieved in seven out of 11 retreatment experiences and that brentuximab vedotin was well-tolerated in the retreatment setting. The data were presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Friday ASCO news:
Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today reported the results from its Phase 2 clinical trial of IPI-504, the company's i.v.-administered Hsp90 chaperone inhibitor, in patients with advanced non-small cell lung cancer (NSCLC). Data reported show that IPI-504 demonstrated clinical activity in patients with NSCLC, in particular among patients with oncogenic anaplastic lymphoma kinase (ALK) gene rearrangements. Dr. Lecia Sequist of Massachusetts General Hospital will present the data in a poster discussion session on Monday, June 7 at the 2010 Annual Meeting of the American Society of Clinical Oncology.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, today announced positive data from a Phase II clinical trial treating front-line non-small cell lung cancer (NSCLC) patients with bavituximab in combination with paclitaxel and carboplatin. 43% (21 of 49 patients) of patients achieved an objective tumor response. Median progression-free survival (PFS) was 6.1 months and median overall survival will be reported once these data mature. These results are superior to data showing an objective response rate of 19% in a similar patient population receiving the same treatment regimen of carboplatin and paclitaxel alone from the published study upon which Peregrine's trial was based. Peregrine's Phase II data will be highlighted in a poster presentation on June 6, 2010 at the ASCO Annual Meeting.
Other news Friday:
Accelrys, Inc. (NASDAQ:ACCL), a leading scientific informatics software and services company, today announced that Accelrys experts will present at two conferences the week of June 7th.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that Larry Bullock, CFO, will provide an update of corporate activities at the Sixth Annual Noble Financial Equity Conference on Tuesday, June 8th at 9:00 a.m. EDT.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will present at the Annual Needham Healthcare Conference to be held in the New York Palace Hotel, New York City from June 9-10, 2010.
Celgene International Sàrl (NASDAQ:CELG) today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin’s lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. District Court for the District of Delaware notified Cubist that the Markman hearing previously scheduled for June 9, 2010 has been cancelled.
DaVita Inc. (NYSE: DVA), a leading provider of kidney care services for those diagnosed with chronic kidney disease (CKD), announced today that on May 28, 2010, it received a subpoena from the Dallas office of the Department of Health and Human Services, Office of Inspector General (OIG).
Deltagen, Inc. (Pink Sheets:DGEN), a leading provider of drug discovery tools to the biopharmaceutical industry, today reported unaudited consolidated financial results for the three months ended March 30, 2010.
Crucell N.V.(Nasdaq:CRXL) today announced that the Annual General Meeting of Shareholders (AGM) held today in Leiden adopted the 2009 financial statements.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s Board of Directors appointed Marvin White as a Class II Director for a one-year term that will expire at the 2011 annual meeting of stockholders.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the publication of data from studies of a dual agonist of Toll-like Receptor 7 (TLR7) and TLR8 in pre-clinical models of cancer.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg, the generic version of Pfizer's Neurontin® Tablets for the treatment of postherpetic neuralgia, a complication of shingles.
OPKO Health, Inc. (NYSE Amex: OPK) today announced that senior management will present at the Jefferies 2010 Global Life Sciences Conference, June 8, 2010 at 1:30 PM EDT.
Orthofix International (NASDAQ: OFIX) announced today that its sports medicine division, Breg, is a recipient of the 2010 CIO 100 award presented by International Data Group's CIO magazine.
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its 2% Convertible Senior Subordinated Notes due 2025 (the "notes") are convertible at the option of the holders and will remain convertible at least through July 6, 2010, as provided for in the Indenture (the "Indenture") governing the notes.
Pharmacyclics, Inc. (Nasdaq: PCYC), a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of immune mediated diseases and cancer, today announced presentations at several investor conferences in June.
Positron Corporation (OTCBB:POSC) a molecular imaging solutions company focused on Nuclear Cardiology, announced today that Michael Stewart, BSRT, CNMT has joined Positron as its new South Central Regional Sales Representative.
Spring Creek Capital Corporation (OTCBB: SCRK), a healthcare solutions company whose business plan is distributing cutting edge solutions for the medical, pharmaceutical and healthcare markets, today announces the release of a white paper on the overall state of the wound care market by the editors of SmallcapInsights.com.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today confirmed that its partner, R-Tech Ueno, Ltd. ("RTU") (Osaka Securities Exchange Hercules code: 4573), reported the results of its recently completed phase 2 clinical trial of UF-021 in retinitis pigmentosa patients.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive results from a study assessing a new lower-volume injection of Copaxone® (glatiramer acetate) containing the currently approved dose in half the injection volume.
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