Stemline Says SL-401 Showed Multi-Cycle Safety, Efficacy; Seattle Genetics Announces Clinical Data Presentations from Multiple Antibody-Drug Conjugate Programs Print E-mail
By Josh Gee   
Thursday, 28 May 2015 19:18
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 28, 2015.  
 
Stemline Therapeutics, Inc. (NASDAQ: STML) announced top-line results from the lead-in stage of its ongoing SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). These results demonstrate an acceptable safety profile, with no cumulative side effects observed after multiple cycles of SL-401 administered at dose levels up to 12 ug/kg/day. Three out of five BPDCN patients treated at the 12 ug/kg/day dose achieved major responses to date, including complete responses (CRs). Stemline intends to continue to enroll BPDCN patients in this ongoing pivotal trial at the 12 ug/kg/day dose level.
The lead-in stage of the corporate-sponsored SL-401 pivotal trial in BPDCN was designed to establish the safety, tolerability and efficacy of multiple cycles of SL-401 administered at three escalating dose levels: 7, 9, and 12 ug/kg/day for up to 5 days, repeated every 3 weeks. The trial enrolled 15 patients with either BPDCN or acute myeloid leukemia (AML). Side effects were similar to those reported in an earlier physician-sponsored clinical study and included manifestations of capillary leak and transient liver function test elevations. Cumulative toxicity was not observed in patients receiving multiple cycles of SL-401, including ten patients who have received at least two cycles, four of whom have received at least five cycles. At the multi-cycle dose-schedule of 12 ug/kg/day, three out of five BPDCN patients achieved major responses to date, including CRs, and patients remain on study. Major responses were also seen at lower doses. Stemline anticipates reporting full results of the lead-in stage later this year.
Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development, commented, "We are very pleased with the results observed with multiple cycles of SL-401 in the lead-in stage of our ongoing pivotal trial in BPDCN. We have witnessed a tolerable safety profile of SL-401 and, importantly, a lack of cumulative toxicity with multiple cycles. We have also observed antitumor activity, including CRs, with SL-401 in BPDCN patients." Dr. Rowinsky continued, "We are working diligently with investigators to rapidly advance the pivotal trial in an effort to register SL-401 in patients with BPDCN both in the United States and in Europe. These trial results also amplify our enthusiasm for SL-401 not only in BPDCN, but in other difficult to treat IL-3R+ malignancies."
 
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Seattle Genetics, Inc. (NASDAQ: SGEN) announced data from multiple proprietary and collaborator antibody-drug conjugate (ADC) programs will be highlighted in more than 10 sessions at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting being held May 29 to June 2, 2015 in Chicago, IL. Presentations will feature data from several corporate and investigator-sponsored trials with ADCETRIS® (brentuximab vedotin), including additional analyses from the phase 3 AETHERA clinical trial and updated data in frontline diffuse large B-cell lymphoma (DLBCL). In addition, the company's ADC collaborators, including Genentech (a member of the Roche Group), AbbVie, Genmab and Agensys (an affiliate of Astellas), will report data from clinical programs using Seattle Genetics' ADC technology. Seattle Genetics will also present preclinical data from its novel SEA-CD40 immuno-oncology candidate currently being evaluated in a phase 1 clinical trial.
Seattle Genetics is evaluating its ADC technology broadly through ADCETRIS, proprietary pipeline and collaborator programs. The company is leading the field in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition, Seattle Genetics is building on expertise in empowered, targeted approaches for the treatment of cancer in advancing its proprietary sugar-engineered antibody (SEA) technology, a novel technology designed to increase the potency of monoclonal antibodies through glycoengineering which may lead to an improved antitumor immune response.
Corporate, investigator and collaborator presentations are included below and full abstracts can be accessed on the ASCO website at abstracts.asco.org.
Saturday, May 30, 2015 -- A sugar engineered non-fucosylated anti-CD40 antibody, SEA-CD40, with enhanced immune stimulatory activity alone and in combination with immune checkpoint inhibitors (Seattle Genetics; Abstract #3074, poster presentation).  
A phase I, first-in-human study to evaluate the tolerability, pharmacokinetics and preliminary efficacy of HuMax-tissue factor-ADC in patients with solid tumors (Genmab; Abstract #2570, poster presentation)
Preclinical efficacy studies using HuMax-Axl-ADC, a novel antibody-drug conjugate targeting Axl-expressing solid cancers (Genmab; Abstract #3066, poster presentation)
ABT-414 in patients with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR) (AbbVie; Abstract #2510, poster presentation)
STEAP1 as a predictive biomarker for antibody-drug conjugate (ADC) activity in metastatic castration resistant prostate cancer (mCRPC) (Genentech; Abstract #5029, poster presentation)
Sunday, May 31, 2015 -- Multivariate analysis of PFS from the AETHERA trial: a phase 3 study of brentuximab vedotin consolidation after autologous stem cell transplant for HL (Seattle Genetics; Abstract #8519, poster presentation)
Phase 1 trial of brentuximab vedotin in combination with gemcitabine for pediatric and young adult patients with relapsed or refractory Hodgkin lymphoma, a Children's Oncology Group report (Investigator-sponsored; Abstract # 8544, poster presentation)
Monday, June 1, 2015 -- Updated results of a phase 2 trial of brentuximab vedotin combined with RCHOP in frontline treatment of pts with high-intermediate/high-risk DLBCL (Seattle Genetics; Abstract #8506, oral presentation 11:21 a.m. CT)
Quality of life EQ-5D results from the AETHERA trial: a phase 3 study of brentuximab vedotin consolidation following autologous stem cell transplant for HL (Seattle Genetics; Abstract #6568, poster presentation)
Brentuximab vedotin plus AVD for non-bulky limited stage classical Hodgkin lymphoma: a phase 2 trial (Investigator-sponsored; Abstract #8505, oral presentation 11:09 a.m. CT)
Two doses of polatuzumab vedotin (PoV, anti-CD79b antibody-drug conjugate) in patients (pts) with relapsed/refractory (RR) follicular lymphoma (FL): Durable responses at lower dose level (Genentech; Abstract #8503, oral presentation 9:45 a.m. – 12:45 p.m. CT)
Phase I study of ABT-414 mono- or combination therapy with temozolomide (TMZ) in recurrent glioblastoma (GBM) (AbbVie; Abstract #2016, poster presentation)
Tuesday, June 2, 2015 -- Ph 1 studies of anti-ENPP3 antibody drug conjugates (ADCs) in advanced refractory renal cell carcinomas (RCC) (Agensys; Abstract #2503, oral presentation 8:00 – 11:00 a.m. CT).
 
Also Thursday:
 
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, announces that its Executive Chairman, Raymond F. Akers Jr., Ph.D, will present to prospective investors next week at the LD Micro investor conference.
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, Cushing's disease and autoimmune and inflammatory diseases, today announced that Randall C. Schatzman, Ph.D., President and Chief Executive Officer, will present at the Jefferies 2015 Healthcare Conference on Thursday, June 4, 2015, at 1:00 p.m. EDT in New York.
American CareSource Holdings, Inc. (Nasdaq:ANCI), owner of urgent and primary care centers and a national network of ancillary health care providers, announced today the employment of its new President and Chief Operating Officer, Norman Winland.
Amedisys, Inc. (Nasdaq:AMED), one of America’s leading healthcare at home companies, today announced that Paul B. Kusserow, President and Chief Executive Officer, will present at the Jefferies 2015 Healthcare Conference in New York, NY on Monday June 1, 2015.
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the launch of Vitaros® in France by Laboratoires Majorelle. Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"), is also marketed as Vytaros® in Belgium and Virirec™ in Spain.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on developing therapeutics in cancer and other life threatening diseases, today announced that in-vitro data for its investigational agent AR-12 (also referred to as OSU-03012) generated by the Viral Special Pathogens Branch of the U.S. Centers for Disease Control and Prevention (CDC) was published online in the journal Antiviral Research.
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the appointment of Richard J. Daly to the position of interim Chief Commercial Officer.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the initiation of an open-label, Phase 1/2 safety and tolerability study examining the investigational combination of varlilumab and sunitinib (SUTENT®) in patients with metastatic clear cell renal cell carcinoma (CC-RCC). Varlilumab is Celldex's fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. 
Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, together announced today that a poster will be presented highlighting in vitro pre-clinical data for FCX-007, a gene-therapy drug candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), at the 2015 European Society of Human Genetics (ESHG) Annual Meeting in Glasgow, Scotland, United Kingdom from June 6-9, 2015.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Healthcare Conference in New York City on Thursday, June 4 at 8:30 AM Eastern Daylight Time.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present our immunotherapy pipeline at the Sachs Immuno-Oncology BD&L and Investment Forum. 
Green PolkaDot Box Incorporated (OTC:GPDB) announced today that Innovision Health Media ("IHM"), a premier magazine and periodical publisher in the health and wellness market space, has entered into an agreement with Green PolkaDot Box to become a Health Merchant™.
iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will present at the 5th Annual LD Micro Invitational at the Luxe Sunset Hotel in Los Angeles, CA.
Juno Therapeutics (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, announced today the appointment of Hyam I. Levitsky, M.D., as executive vice president, research and chief scientific officer, effective immediately. 
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive technologies and techniques, today announced that the Company's Chief Financial Officer, Greg Cole, will participate in the William Blair Growth Stock Conference at the Four Seasons Hotel in Chicago, Illinois.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that David Roberts, President, will present at the Three Part Advisors East Coast IDEAS Conference Wednesday, June 3, 2015 at the Boston Park Plaza Hotel, Boston, MA. 
MedAssets (Nasdaq:MDAS) today announced that Jackson Health System (Jackson), a not-for-profit academic medical system serving residents of Miami-Dade County, renewed its supply chain relationship with the company to achieve greater cost reduction across the organization.
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), today announced that the financial results for its fiscal fourth quarter 2015, ended March 31, 2015, will be released after the U.S. markets close on June 11, 2015.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cell (CSC) and immuno-oncology pathways, today announced that Paul J. Hastings, Chairman and Chief Executive Officer, will speak at upcoming investor conferences in June.
Phenogen Sciences, Inc., the U.S. subsidiary of Australia-based Genetic Technologies Limited (NASDAQ: GENE), today notes with interest the special report on May 27, 2015 in The New England Journal of Medicine entitled, "Gene-Panel Sequencing and the Prediction of Breast Cancer Risk" authored by DF Easton, et al.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that Faheem Hasnain, its President and Chief Executive Officer, will be presenting at the Jefferies 2015 Global Healthcare Conference at the Grand Hyatt hotel in New York City. 
ScripsAmerica, Inc. (OTCBB:SCRC), a leading provider of a range of specialty prescription and over the counter pharmaceuticals and medical supplies, today announced that it has received a license to distribute its pharmaceuticals in the State of Ohio. 
Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, announced today that Hani Zeini, Founder, President and Chief Executive Officer, will present at the William Blair 35th Annual Growth Stock Conference on Tuesday, June 9, 2015 at 2:10 p.m. Central Time.
Stemline Therapeutics, Inc. (Nasdaq:STML) today announced top-line results from the lead-in stage of its ongoing SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the initiation of the Phase 3 study of aceneuramic acid extended release (Ace-ER), previously known as sialic acid-extended release (SA-ER; UX001), tablets for the treatment of GNE Myopathy. Ace-ER is designed to replace the deficient sialic acid substrate in patients with GNE Myopathy, also known as Hereditary Inclusion Body Myopathy (HIBM), a rare, progressive muscle-wasting disease.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that the gevokizumab Phase 3 EYEGUARD-B study, sponsored by its development partner Servier, reached its target exacerbation event as specified in the study design.



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