|Repros Updates Status of Proellex(R); Spectrum Announces Enrollment in Phase 1 for RenaZorb®|
|By Staff and Wire Reports|
|Tuesday, 29 May 2012 20:01|
Repros Therapeutics Inc.® (Nasdaq:RPRX) announced the FDA has advised the Company it must complete an integrated safety analysis of completed studies of oral Proellex®. Once completed, the report must be submitted to the FDA for review prior to any additional trials on oral administration of telapristone acetate, the active ingredient of Proellex®. The FDA has committed to reviewing the findings within 30 days to allow a potential continuation of the low dose oral program.
The Company plans to submit the document over the next few weeks and believes it will demonstrate an acceptable risk-benefit of oral Proellex® in order to warrant further studies. The Company intends to commence a Phase 2/3 study in the treatment of endometriosis, if allowed. Repros believes that endometriosis may represent an indication with some clinical development advantages for an oral therapy.
Spectrum Pharmaceuticals (NASDAQ:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb® (also referred to as SPI-014) in healthy volunteers. RenaZorb is a lanthanum-based nanotechnology compound with potent phosphate-binding properties.
We are excited to announce the first human clinical study of RenaZorb, which we have initiated based on the promising research findings we have seen, stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. Over 90% of patients with kidney failure use oral phosphate binders to prevent hyperphosphatemia, yet there is often poor compliance due to gastrointestinal (GI) intolerance and excessive pill burden associated with current therapies. Further, in vitro research has shown that RenaZorb has much higher phosphate-binding capacity than current products on the market. We believe this will allow us to provide the same amount of phosphate-binding capacity at a lower dose and smaller tablet size, thus improving patient compliance. Based on these and other product characteristics, we feel RenaZorb has the potential to offer increased patient benefit and look forward to the swift completion of Phase 1 testing and further progress of the program.
The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.
Alkermes plc (NASDAQ: ALKS) today presented positive results from the phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, in an oral session at the 52nd Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting in Phoenix.
Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) will be presenting at the Jefferies 2012 Global Healthcare Conference on Tuesday, June 5 at 1:30 p.m. ET/10:30 a.m. PT in New York and at the Goldman Sachs 33rd Annual Global Healthcare Conference on Wednesday, June 6 at 2:20 p.m. ET/11:20 a.m. PT in Rancho Palos Verdes, California.
BIOLASE, Inc. (NASDAQ: BIOL), the World's leading dental laser manufacturer and distributor, announced that its common shares will begin trading under the new ticker symbol "BIOL" effective at the market open today.
Bio-Path Holdings, Inc. (OTCBB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has completed treatment of the third dosage cohort in its Phase I clinical trial of its lead product candidate, BP-100-1.01 (Liposomal Grb-2), which is a systemic treatment for blood cancers, including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS).
DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced NTT DATA signed a non-exclusive license to resell DATATRAK ONE™ in the Chinese market.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, PhD President and Chief Executive Officer, is scheduled to present at the 9th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 30, 2012 at 10:55 am Central Time, at the Minneapolis Marriott City Center Minneapolis, Minnesota.
Horizon Pharma, Inc. (NASDAQ: HZNP) announced today that the U.S. Patent and Trademark Office has issued patent number 8,168,218 titled "Delayed Release Tablet with Defined Core Geometry" that covers RAYOS® (5 mg Delayed-Release Prednisone).
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) will present at the Goldman Sachs 33rd Annual Global Healthcare Conference on Tuesday, June 5, 2012 at 8:40 a.m. Pacific Time (11:40 a.m. Eastern Time) at Terranea Resort in Rancho Palos Verdes, CA.
IsoRay Inc. (NYSE Amex: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced that Discovery Channel has featured the Company's Cesium-131 brachytherapy (internal radiation therapy) treatment for localized prostate cancer.
McKesson Corporation (NYSE:MCK) today announced that Jeff Campbell, executive vice president and chief financial officer, will present at the Goldman Sachs 33rd Annual Global Healthcare Conference in Rancho Palos Verdes at 4:00 p.m. PT on Tuesday, June 5, 2012.
Mylan Inc. (Nasdaq: MYL) today announced that Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into a settlement agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/3 mL and 1.25 mg/0.5mL.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Jefferies 2012 Global Healthcare Conference in New York.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) will present at the Jefferies 2012 Global Healthcare Conference in New York on Monday, June 4, 2012 at 11:30 a.m. ET.
Oncothyreon Inc. (Nasdaq: ONTY) announced today that Robert Kirkman, M.D., President and Chief Executive Officer, will be presenting at the Jefferies 2012 Global Healthcare Conference in New York on Tuesday, June 5, 2012 at 4:00 p.m. Eastern.
Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has received approval for a key patent by the New Zealand Patent Office.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today that it has received transitional pass-through status from the Center for Medicare & Medicaid Services (“CMS”), with C-Codes being designated for Grafix®.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the Company's participation at the Jefferies 2012 Global Healthcare Conference at the Grand Hyatt in New York, NY on June 4-7, 2012.
Stevia First Corp.(OTCBB: STVF) ("Stevia First" or the "Company"), an early-stage agribusiness based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, has received an acceleration of funds from a recent financing and entered into agreements to exchange all existing promissory notes into shares of common stock, with full details available for review as filed with the Securities and Exchange Commission.
Trimedyne, Inc. (OTCBB: TMED) today reported its financial results for the quarter and six month period ended March 31, 2012.
VentriPoint Diagnostics Ltd. ("VentriPoint") (TSX VENTURE:VPT) (OTCQX:VPTDF) exhibited its VMS™ heart analysis system at the Annual Meeting of the Association of European Paediatric Cardiologists (AEPC) from May 23-26 in Istanbul, Turkey.