|Repros Allowed to Conduct Phase 1 and 2 Clinical Studies of Low Dose Oral Proellex(R); Amgen Announces Positive Top-Line Results From Phase 3 AMG 145|
|By Staff and Wire Reports|
|Monday, 17 March 2014 19:08|
Repros Therapeutics Inc. (Nasdaq:RPRX) reported it has received guidance from the FDA indicating that Repros may proceed to conduct Phase 1 and 2 studies of oral Proellex® under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold. The FDA guidance provides that the highest allowed dose will be 12 mg daily. Repros is currently conducting a Phase 2 study for the use of Proellex in severe endometriosis and plans to submit a Phase 2 protocol for the treatment of symptomatic fibroids.
Regarding the proposed uterine fibroid Phase 2 protocol, the FDA provided guidance as to the appropriate inclusion and exclusion criteria for study subjects as well as the preferred efficacy endpoint. The FDA preferred efficacy endpoint is reduction in excessive menstrual bleeding associated with uterine fibroids. The FDA also noted the preferred methodology to determine changes in bleeding. Repros will comply with FDA guidance as well as collecting additional efficacy outcomes such as tumor size and other symptomatic relief.
Given the prior experience with Proellex at 6 and 12 mg daily dosages, Repros plans to enroll fewer than 75 women in a three arm, parallel design double blind trial. The study is sized to provide greater than 90% power in demonstrating efficacy associated with reducing subject bleeding.
Amgen (NASDAQ: AMGN) today announced that the Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). The percent reduction in LDL-C, or "bad" cholesterol, was clinically meaningful and statistically significant. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1
TESLA was a two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C at an early age.2 The Phase 3 TESLA trial evaluated the safety, tolerability and efficacy of evolocumab compared to placebo in 49 adult and adolescent (12 to less than 18 years of age) patients with HoFH who were on a stable dose of statin therapy and other lipid-lowering medication. Patients were randomized to evolocumab 420 mg subcutaneous monthly or placebo subcutaneous monthly.
Safety was generally balanced across treatment groups. The most common adverse events in the evolocumab group (more than one subject) were upper respiratory tract infection, influenza, gastroenteritis and nasopharyngitis.
"Homozygous familial hypercholesterolemia is a rare and devastating disease characterized by extremely high LDL-C levels that increase cardiovascular risk in these patients, many of whom are affected at an early age," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are encouraged by the results of the TESLA trial, the first Phase 3 data of a PCSK9 inhibitor in homozygous familial hypercholesterolemia patients, which suggest evolocumab may offer a new treatment option for these patients who currently have significant unmet medical needs."
Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.3 HoFH is a rare, serious inherited condition that can lead to/cause high levels of LDL-C at an early age.2 It is a rare form of familial hypercholesterolemia occurring in approximately one in a million individuals, who have two altered copies of a cholesterol regulating gene (one from each parent) that result in absent or defective LDL receptor function.2,4 HoFH can cause a four-fold increase in LDL-C levels (e.g., 400-1,000 mg/dL).2,5
"We are encouraged by the data from another Phase 3 trial in our clinical development program showing that evolocumab reduces LDL cholesterol and in this case, in patients with a rare and serious genetic condition," Harper added. "These results add to the data from our five previously announced positive Phase 3 studies of evolocumab in other patient populations."
Details of the Phase 3 TESLA trial will be submitted to a future medical conference and for publication.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today the closing of its initial public offering of 6,900,000 shares of its common stock at a price to the public of $12.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 900,000 additional shares of common stock to cover over-allotments, resulting in aggregate gross proceeds of $82,800,000, before underwriting discounts, commissions and estimated offering expenses.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that it has signed an agreement with the University of California, San Francisco (UCSF), under which Lawrence Fong, M.D., Professor in the Department of Medicine and principal investigator of the studies at UCSF, will evaluate several new immunotherapy constructs, in addition to ADXS-PSA, each built on the Advaxis proprietary technology.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, announced that it has entered into a binding term sheet to settle the OrthoTec, LLC vs. Surgiview S.A.S. legal matter.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, announced today financial results for the fourth quarter and full year ended December 31, 2013.
Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2013.
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that Doug Plessinger, vice president of clinical and medical affairs, is scheduled to present at the 2nd Annual Sachs Cancer Bio Partnering & Investment Forum at the New York Academy of Sciences in New York City.
Cancer Genetics (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced today that effective April 1, 2014, it has appointed Edward J. Sitar, CPA as Chief Financial Officer.
Cellular Biomedicine Group Inc. (OTCQB:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced the launch of their pre-clinical study on human adipose derived mesenchymal progenitor cell (haMPC) therapy for asthma.
At its annual meeting held on Monday, March 17, 2014 in Pleasanton, California, the stockholders of The Cooper Companies, Inc. (NYSE:COO) elected eight directors and ratified the appointment of KPMG LLP as the Company's auditors for fiscal 2014.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that Dr. Robert S. Epstein, M.D., has joined its Board of Directors.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today reported therapeutic program updates and announced financial results for the fourth quarter and year ended December 31, 2013.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the quarter and year ended December 31, 2013 and provided a business update.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer, virtual administrator and private exchange for affordable, cloud-based individual health insurance plans and ancillary products, today reported financial and operating results for the fourth quarter and full fiscal year ended December 31, 2013.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that data highlighting the potential pharmacoeconomic benefit of Zerenex™ (ferric citrate coordination complex), the Company's drug candidate for the treatment of hyperphosphatemia in dialysis patients, has been selected for poster presentation during the upcoming Academy of Managed Care Pharmacy's (AMCP) 26th Annual Meeting and Expo, being held April 1-4, 2014, at the Tampa Convention Center in Tampa, Florida.
Kips Bay Medical, Inc. (Nasdaq:KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, announced today that the United States Food & Drug Administration ("FDA") has granted an approval for Kips Bay Medical to include more U.S. patients and U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS® Mesh.
KYTHERA Biopharmaceuticals, Inc.(Nasdaq:KYTH) today reported financial results for its quarter and year ended December 31, 2013, and provided an update on recent accomplishments.
Luminex Corporation (NASDAQ: LMNX) announced today that xMAP® Technology is playing a key role in the biobank profiling research within the Human Protein Atlas (HPA) project.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, today announced that, on March 11, 2014, the Data Safety Monitoring Board recommended continuing the PreSERVE AMI Phase 2 clinical trial following a fourth interim data and safety review.
Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Dr. Professor Walter H. Günzburg, Chairman and Chief Technical Officer of Nuvilex's partner SG Austria Pte. Ltd., gave a major presentation at the international BioPharma Asia Convention 2014 that was held in Singapore March, 10-13, 2014.
OmniComm Systems, Inc. (OTCQB: OMCM) signed a $2.5 million contract for one Phase II and four Phase III global studies with a major east coast biotechnology company to supply OmniComm's market leading electronic data capture (EDC) technology, TrialMaster 4.2.
Prosensa Holding N.V. (NASDAQ: RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today reported encouraging 48-week data from its U.S.-based, Phase II placebo-controlled study (DMD114876 or DEMAND V) of its lead compound, drisapersen, for the treatment of Duchenne Muscular Dystrophy (DMD).
Relypsa, Inc. (Nasdaq: RLYP), a biopharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2013.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported it has received guidance from the FDA indicating that Repros may proceed to conduct Phase 1 and 2 studies of oral Proellex® under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold.
Star Scientific, Inc. (NASDAQ: STSI) today filed its annual report on Form 10-K with the Securities & Exchange Commission (SEC).
Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing solutions, today announced that it will report its fourth quarter 2013 results after market close on Monday, March 17, 2014 and will host a conference call and live webcast to discuss the results on Tuesday, March 18, 2014 at 8:30 AM Eastern time.
Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing solutions, announced today results for the three-month and full year periods ended December 31, 2013.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, confirmed published reports that a minor electrical fire occurred at its Sheffield, UK manufacturing plant during the evening of Saturday, March 8, 2014.
Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today reported its financial results for the quarter and the year ended December 31, 2013.
uniQure N.V. (Nasdaq: QURE), a leader in human gene therapy, and Chiesi Farmaceutici S.p.A. ("Chiesi"), a leading international pharmaceutical company, today announced initial analysis of retrospectively collected individual patient data from LPLD patients treated with Glybera®.
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, is pleased to announce that Cheryl Pegus, M.D., President of Caluent, Director and Strategic Advisor of Glytec, and the Lead Independent Director of Vision-Sciences, will appear on a segment of the Bloomberg News TV show "Taking Stock with Pimm Fox" on Wednesday, March 19, 2014 during the 5:00 – 6:00 PM EDT hour.