Theravance Biopharma Presents Additional Positive Phase 2b Study Data on TD-4208; Actinium To Provide Clinical Update on ACTIMAB-A Print E-mail
By Marilyn Mullen   
Wednesday, 20 May 2015 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 20, 2015.  
Theravance Biopharma, Inc.  (NASDAQ: TBPH) announced the presentation of additional positive data from its Phase 2b dose-ranging study of TD-4208, an investigational long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD). Previously released top-line study data demonstrated achievement of the study's primary and key secondary efficacy endpoints for doses of 88 mcg and above. Additional trial results presented today support the product's potential to offer patients rapid and sustained therapeutic benefit from once-daily administration and to reduce the requirement for short-acting rescue medication. These latest data are being presented at the American Thoracic Society (ATS) 2015 International Conference being held this week in Denver, Colorado.
The Phase 2b study evaluated four doses of TD-4208 (44, 88, 175 and 350 mcg) and placebo, administered once-daily for 28 days in a double-blind, parallel group study in a total of 355 patients with moderate-to-severe COPD. As previously reported, TD-4208 met the primary efficacy endpoint (change from baseline in trough FEV1 [forced expiratory volume in one second] following the last dose on Day 28) at once-daily doses of 88, 175 and 350 mcg, with statistically significant changes versus placebo (p < 0 .001) in trough FEV1 of 187 mL, 167 mL and 171 mL, respectively. TD-4208 was generally well tolerated in the study with headache (3.1%), shortness of breath (2.8%) and cough (2.0%) as the most common adverse events in the study.
In new data from the Phase 2b study reported at ATS, TD-4208 resulted in a rapid onset of action, with a median time to achieve a clinically relevant improvement in lung function (at least 100mL increase in FEV1) of 30 minutes for doses of 88 mcg and above. TD-4208 also reduced the requirement for short-acting inhaled rescue medication in a dose-dependent manner, with a mean reduction of more than one puff a day compared to placebo for doses of 88 mcg and above (p < 0.001).
In a separate presentation at ATS, Theravance Biopharma announced new population pharmacokinetic (PK) analyses from three Phase 2 studies of TD-4208 that support the product's profile as a well-tolerated, once-daily inhaled treatment with limited systemic exposure. Combined with safety and efficacy data from the Phase 2b dose ranging study, these findings reaffirm the sustained bronchodilator effects of TD-4208 in the lung and support the minimal antimuscarinic effects outside the lung at the intended clinical doses.
"The positive Phase 2b clinical study results with TD-4208 are encouraging, and particularly relevant in light of the fact that there are still limited treatment options for COPD patients who require long-acting nebulized bronchodilator therapy," said Brett Haumann, MD, Senior Vice President, Clinical Development at Theravance Biopharma. "Approximately 9% of COPD patients in the U.S. require or prefer nebulized therapy, but there are currently no once-daily bronchodilators of any class available via the nebulized route. We believe there is a compelling opportunity to provide these patients with access to a once-daily nebulized treatment. Importantly, data from our Phase 2b study of TD-4208 demonstrate a therapeutic profile that is consistent with once-daily dosing, an onset of action that provides prompt effect and the potential for a reduced dependence on short-acting rescue medication. We plan to evaluate these effects further in longer-term studies in Phase 3."
Following end-of-Phase 2 discussions with the FDA, Theravance Biopharma is preparing to start the TD-4208 Phase 3 registrational program, which is anticipated to begin later this year. The Phase 3 registrational program will include two replicate three-month efficacy studies and a single twelve-month safety study. The studies will include approximately 2,300 patients and test two doses: 88 mcg and 175 mcg administered once-daily via nebulizer.
In February 2015, Theravance Biopharma announced that it had entered into a partnership with Mylan Inc. and its affiliates for the development and, subject to FDA approval, commercialization of nebulized TD-4208 for COPD and other respiratory diseases. Under terms of the agreement, Theravance Biopharma will conduct development in the U.S. with all costs reimbursed by Mylan. Mylan is responsible for ex-U.S. development. Additionally, Theravance Biopharma is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on U.S. sales and double-digit royalties on ex-U.S. sales. Theravance Biopharma retains worldwide rights to TD-4208 delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI), and the rights to nebulized TD-4208 in China.
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced the upcoming poster and abstract at ASCO 2015, the 51st Annual Meeting of American Society of Clinical Oncology, to be held in Chicago on May 29 – June 2. Data will be presented from the Company’s ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients.
Clinical data from the first three cohorts will be discussed. Cohort 3, which included 3 additional patients, demonstrated no dose limiting toxicities in patients older than 60 and up to 87 years of age who were not eligible for currently approved therapies. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 88% in the bone marrow. In the previous cohort treated at a lower dose level of Actimab-A, one patient achieved CRi. The Company also recently announced that it began the fourth and last cohort (2.0 μCi/kg per dose) in the Phase I portion of this trial.
Title:  Phase I trial of α-particle therapy with actinium-225 (225Ac)-lintuzumab (anti-CD33) and low-dose cytarabine (LDAC) in older patients with untreated acute myeloid leukemia (AML).
Lead Author:  Dr. Joseph G. Jurcic, Columbia University Medical Center, Sunday May 31, 2015, 8:00 AM – 11:30 AM,  McCormick Place, Chicago, Illinois, Poster Board #39 in S Hall A; Abstract #7050.
Dr. Jurcic is Director of the Hematologic Malignancies Section of the Hematology/Oncology Division and Professor of Clinical Medicine at Columbia University Medical Center. He is a hematologist/oncologist focusing on the treatment of acute and chronic leukemias, myeloproliferative neoplasms, and myelodysplastic syndrome. His research interests include acute myeloid leukemia, radioimmunotherapy with alpha and beta particle-emitting radioisotopes, monoclonal antibody therapy for leukemia, development of novel small molecule inhibitors for leukemia and molecular monitoring of minimal residual disease. He is the primary investigator for the current Actimab-A clinical trial and Clinical Advisory Board Chairman. He received his medical degree from the University of Pennsylvania and completed his fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center.
"The positive results on both safety and anti-leukemic effect demonstrated in the completed third cohort represents a significant achievement for the Actimab-A program, and support the advancement to a higher dose with the potential to further enhance the already strong results we have seen to date," stated Dragan Cicic, MD, Chief Medical Officer of Actinium. "We believe the responses observed for Actimab-A, with minimal toxicity being reported, are impressive in this disease setting. These findings build upon those presented and published over the past year which demonstrated a clear survival benefit in secondary AML patients. We remain steadfast in our belief that Actimab-A could play an important role in the treatment regimen for newly diagnosed elderly AML patients who currently have limited treatment options.”
Also Wednesday:

ACETO Corporation (Nasdaq:ACET), a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that Sal Guccione, President and CEO, will present at the Jefferies 2015 Global Healthcare Conference on June 3, 2015 at 1:30 pm ET.
Adaptimmune (Nasdaq:ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that it has augmented its senior management team with the additions of Lini Pandite, M.D. as Senior Vice President, Clinical Development, and Anne-Marie (Annie) Martin, Ph.D. as Vice President, Head of Biomarker Research and Development.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that the Company's President and Chief Executive Officer, Jim Corbett, will participate in the Jefferies Healthcare Conference on Wednesday, June 3, 2015 at 11:00 AM Pacific Time at the Grand Hyatt Hotel, New York City, New York.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced financial results for the three months ended March 31, 2015. 
Analogic Corporation (Nasdaq:ALOG) announced today that it will conduct a conference call on Thursday, June 4, 2015, at 5:00 p.m. (ET) to discuss results for the third quarter ended April 30, 2015. 
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that Dr. Charles Nicolette, the company's chief scientific officer and vice president of research and development, and Dr. Fred Miesowicz, the company's chief operating officer and vice president of manufacturing, will present at the World Stem Cells Regenerative Medicine Congress being held at the Business Design Centre in London May 20-22, 2015.
athenahealth, Inc. (Nasdaq:ATHN) and Revive Health have updated a release issued earlier today to include two infographics. 
Auris Medical Holding AG (Nasdaq:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, announced today the closing of its previously announced public offering of 5,275,000 of its common shares at a public offering price of $4.75 per common share. 
Avinger, Inc., (Nasdaq:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced 30-day interim results for its VISION clinical study.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, and ReviveHealth, a leading integrated marketing communications firm, today released findings on the state of payer performance and provider perception of those payers.
BioSig Technologies (OTCQB:BSGM), a medical device company developing PURE EP(TM) a proprietary technology platform designed to improve the clarity of clinical signals available for electrophysiology (EP) procedures, today announced that it will be present at the 2015 Marcum MicroCap Conference on Wednesday and Thursday, May 27-28, 2015 in New York City at the Grand Hyatt Hotel.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss first quarter 2015 financial results and provide an update on each of its development programs on Thursday, May 21st at 5:00 PM EDT.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that it has received Institutional Ethics Committee (IEC) approval to initiate the SurgWerks-AMI and VXP System (patent pending) phase II clinical trial.
Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced that Peter Staple, Corium's President and Chief Executive Officer, will present at the Jefferies 2015 Global Healthcare Conference to be held on June 1-4, 2015 in New York City, New York.  
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that their Ekso™ Labs division secured a third contract with the United States Special Operations Command (SOCOM) to work on the next phase of the Tactical Assault Light Operator Suit (TALOS) project.  
Gevo, Inc. (Nasdaq:GEVO) today announced that Dr. Patrick Gruber, Gevo's Chief Executive Officer, will participate on a panel at the Cowen and Company 43rd Annual Technology, Media & Telecom Conference on Thursday, May 28, 2015 at 2:45 PM EDT.
Hemispherx Biopharma (NYSE MKT:HEB) will present at the Marcum Microcap Conference being held at the Grand Hyatt Hotel in New York City on Wednesday, May 27, 2015.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced plans to release historical financial information adjusted for the planned spin-off of its spine business, to become SeaSpine Holdings Corporation. Following the separation, which is expected to be completed in the third quarter, Integra's spine business will be reclassified as discontinued operations.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that its Chairman and CEO, William J. Caragol, will present at the 4th Annual SeeThruEquity Microcap Investor Conference on Thursday, May 28, 2015 in New York City at Convene Grand Central.
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, today announced that Stephen M. Simes, chief executive officer of RestorGenex, is scheduled to present a corporate overview at two upcoming investor conferences.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) announced today that its Chief Executive Officer, Elias Vamvakas, will participate in the 12th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 27, 2015.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, announced today that Lonnie Moulder, CEO of TESARO, will present an overview of TESARO's business and development programs at the Jefferies 2015 Global Healthcare Conference at the Grand Hyatt hotel in New York City on Wednesday, June 3, 2015 at 2:30 PM ET.

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