|Alkermes Announces Advances in Late-Stage CNS Pipeline; CytRx Reports Positive Results from Global Phase 2b Clinical Trial with Aldoxorubicin|
|By Staff and Wire Reports|
|Wednesday, 08 January 2014 20:25|
Alkermes plc (NASDAQ: ALKS) announced new developments related to its late-stage product candidates in its proprietary central nervous system (CNS) pipeline. The company unveiled aripiprazole lauroxil two-month, a new product candidate addition to its portfolio of atypical antipsychotics for the treatment of schizophrenia. If approved, aripiprazole lauroxil two-month would be the first and only long-acting atypical antipsychotic medication dosed every two months. This new two-month product candidate is designed to provide physicians and patients with an even longer dosing option than the once-monthly formulation of aripiprazole lauroxil, which is currently completing the phase 3 study, with topline results expected in the first half of 2014. In addition, Alkermes provided details regarding its pivotal phase 3 program for ALKS 5461, a Fast Track-designated new medicine being evaluated for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies. The phase 3 trials for ALKS 5461 will incorporate state-of-the-art study designs, and the pivotal program is expected to begin in the first quarter of 2014.
“As we begin 2014, Alkermes is aggressively executing on our strategy of building and advancing one of the most exciting CNS pipelines in the industry; one characterized by its potential value to patients and treatment systems,” said Richard Pops, Chief Executive Officer of Alkermes.
“Schizophrenia and major depressive disorder are chronic diseases that affect the daily lives of millions of patients and are conditions where new treatment options with novel mechanisms of action and new dosing regimens are needed,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Clinicians who treat patients with schizophrenia and major depression need better treatment options to achieve stable remission in these serious, chronic conditions. Our goal is to advance clinical care by addressing unmet medical needs with aripiprazole lauroxil and ALKS 5461.”
The aripiprazole lauroxil two-month product candidate is designed to offer physicians and patients a dosing option that is not currently available, and Alkermes plans to begin clinical testing in 2014. Both the one-month and two-month forms of aripiprazole lauroxil are long-acting injectable medications that, once in the body, convert into aripiprazole, a molecule that is commercially available under the name ABILIFY®, and both utilize the company's proprietary LinkeRx® technology.
Alkermes also today announced details regarding the pivotal program and innovative phase 3 clinical trial design for ALKS 5461, a proprietary drug candidate with a novel mechanism for the treatment of MDD. The pivotal clinical program will include three core phase 3 efficacy studies and is expected to enroll a total of approximately 1,500 patients with MDD who have had an inadequate response to standard therapies. The three core efficacy studies will utilize sequential parallel comparison design (SPCD) to reduce the impact of clinically meaningful placebo response. The primary efficacy endpoint for all phase 3 studies will be the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline. The pivotal program will also evaluate remission as a secondary endpoint, following the recently reported remission data from the phase 2 study of ALKS 5461, in which 35-50% of patients in the study achieved remission, as evaluated by MADRS scores, across the two stages of the study. In addition to the three core efficacy studies, the pivotal program will also include studies to evaluate the long-term safety, pharmacokinetic profile, titration schedule and human abuse liability of ALKS 5461. The first study to commence in the ALKS 5461 pivotal program will be a study to evaluate onset of clinical effect, safety and tolerability.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS).
Additional analysis determined hazard ratios for the primary endpoint of progression-free survival (PFS) by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37 (95% confidence interval, range of 0.212 to 0.643) (p=0.0004), reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59 (95% confidence interval, range of 0.36 to 0.96) (p=0.034), reflecting a 41% reduction in the risk of disease progression. Hazard ratios – the likelihood that the study endpoint (in this case tumor progression) will be reached during a given period – are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups.
CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology (ASCO) Meeting in June, 2014 in Chicago, Illinois.
CytRx President and CEO Steven A. Kriegsman commented, “Because of the tremendous potential for aldoxorubicin to treat soft tissue sarcomas and other common cancers, it is important that we present the initial trial analyses in a timely manner. We are very pleased that additional statistical analyses strongly support the earlier top-line results, which reinforces our confidence in the ability of our linker technology to target the release of doxorubicin directly at the site of cancer.”
As initially reported on December 11, 2013, both the investigator assessment and central lab review showed subjects treated with aldoxorubicin demonstrated highly statistically significant better clinical outcomes than those receiving standard doxorubicin therapy for STS. Specifically, both assessments showed an unambiguous 80% to 100% improvement in PFS among patients treated with aldoxorubicin.
In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, today announced its CEO Panna Sharma will present at the following investor conferences: 7th Annual OneMedForumSF 2014, January 13-15, 2014 in San Francisco; CGI will present at 10:30 a.m. PT, Tuesday, January 14; Noble Financial's 10th Annual Equity Conference, January 19-22, 2014 in Sandpiper Bay, Florida; CGI will present at 9:30 a.m. ET, Monday, January 20.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today reported preliminary top-line unaudited results for the fourth quarter and full year 2013.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective, approved medicines targeting orphan neuromuscular and neurological diseases, today announced positive results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals (Nasdaq:BMRN) to assess the cardiac safety of Firdapse™ tablets (amifampridine also known as 3,4-DAP).
ChemoCentryx, Inc. (Nasdaq:CCXI), today announced that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2014, at 3:30 p.m. Pacific Time.
The Cooper Companies, Inc. (NYSE:COO) today announced that, consistent with the plan approved by its board of directors to pay annual dividends, the Company declared a semi-annual dividend of 3 cents per share, payable on February 7, 2014, to stockholders of record on January 24, 2014.
eHealth, Inc. (NASDAQ: EHTH), America's first and largest private health insurance exchange, today announced preliminary financial results for the fourth quarter and fiscal year ended December 31, 2013.
FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that Thijs Spoor, Chairman and CEO of FluoroPharma Medical, will be presenting at the annual Biotech Showcase in San Francisco, at the Wyndham Hotel on Tuesday, January 14th.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today released a report on the Company's key scientific, development and regulatory milestones and corporate activity that contributed to the Company's progress in 2013.
Hyperion Therapeutics (Nasdaq:HPTX) announced today that the company is scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16 at 7:30 a.m. PT.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that it has been awarded a grant from the National Multiple Sclerosis (MS) Society through its affiliate, Fast Forward, to support research on the potential of SINE compounds in inflammatory models of disease, including MS.
MannKind Corporation (Nasdaq:MNKD), focused on discovering, developing and commercializing treatments for diabetes, announced today that it will present at the J.P. Morgan 2014 Healthcare Conference on Wednesday, January 15, 2014 at 7:30 AM (PST) at Westin St. Francis Hotel in San Francisco, California.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, recently learned through an internal review that a former sales employee in its eClinical business had falsified the existence or amount of certain customer contracts.
Nektar Therapeutics' (Nasdaq: NKTR) President and Chief Executive Officer, Howard W. Robin, is scheduled to present at the upcoming 32nd Annual J.P. Morgan Healthcare Conference in San Francisco at the Westin St. Francis Hotel on Tuesday, January 14, 2014 at 10:00 a.m. Pacific time.
NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today provided a business update highlighting recent accomplishments and outlook for 2014.
Ocera Therapeutics (Nasdaq:OCRX) today announced enrollment of the first patient in its multi-center Phase 2b study, the "STOP-HE" or OCR002-HE209 trial.
Oxford Immunotec Global PLC (Nasdaq:OXFD) today announced that Peter Wrighton-Smith Ph.D., Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, California on Thursday, January 16, 2014 at 12:30 pm PT.
Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS) (OTCBB: PINSD) (OTCQB: PINSD), a health and technology holding company with a focus on patentable, innovative, and eco-friendly consumer products, announced today that the board of directors and shareholders of the Company have approved a 3-to-1 reverse split of its Common Stock, as well as a name change to Alkame Holdings, Inc.
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it expects revenues in the fourth quarter of 2013 to be approximately $50 million.
RedChip Companies, Inc., an international small-cap research, investor relations, and media company, today announced that Dr. Harlan Waksal, chairman of Senesco Technologies, Inc. (OTCQB:SNTI), a clinical-stage biotech company specializing in cancer therapeutics, was recently interviewed on "The RedChip Money Report: Small Stocks Big Money."
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) today announced that certain subsidiaries of Sabra (the "Issuers") have commenced a cash tender offer (the "Offer") to purchase any and all of their outstanding $211,250,000 aggregate principal amount of 8.125% Senior Notes due 2018 (the "Notes").
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, today announced that on January 1, 2014, the European Patent Office (EPO) issued patent EP2183693 B1, entitled "Diagnosing Fetal Chromosomal Aneuploidy Using Genomic Sequencing," invented by Drs. Dennis Lo, Rossa Chiu, and Kwan Chee Chan of The Chinese University of Hong Kong.
TelVue® Corporation (PINKSHEETS: TEVE), the innovation leader in Television and Internet Broadcasting for communities, cable operators, and media companies today announced the appointment of Mark Steele to the newly-created position of Chief Information Officer.
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today announced the signing of a five-year agreement to supply Cord Blood Registry® (CBR®), the world's largest and most experienced newborn stem cell company, with ThermoGenesis' AutoXpress® System (AXP) cord blood processing system and disposables.
Urologix®, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today announced a strategic restructuring of its organization and reported preliminary financial results for its fiscal year 2014 second quarter ended December 31, 2013.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced that Jonathan Lewis, M.D., Ph.D., Chief Executive Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15th, 2014 at 11:30 a.m. PT at The Westin St. Francis in San Francisco, CA.