Nymox Reports Positive Results for NX02-0017 Pivotal Phase 3; Celgene Reports Phase III Study of Oral REVLIMID® Print E-mail
By Staff and Wire Reports   
Thursday, 11 July 2013 19:10

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 11, 2013.
Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the most recent Safety Monitoring Committee review of ongoing safety data for the Company's NX02-0017 clinical trial, one of the two Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The July 9, 2013 Safety Monitoring Committee meeting found no significant safety concerns to date. The Company's pivotal Phase 3 trials have completed enrollment and treatment (a single intraprostatic injection of either drug or placebo) and patient evaluation is continuing at over 70 well-known urology investigative sites across the U.S.

NX-1207 is in late stage Phase 3 development in the U.S. for BPH. Phase 3 trial activities of NX-1207 for BPH are ongoing under the sponsor of the Company's European licensing partner, Recordati S.p.A. NX-1207 is a novel patented therapeutic that is administered directly into the prostate by a urologist in an office setting. The procedure does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. NX-1207 has thus far shown none of the adverse sexual side effects associated with approved medical and surgical treatments for BPH.

Previous clinical trials found that a single administration of NX-1207 2.5 mg produced on average improvements in the standardized BPH symptom score (8-10 points at 90 days) that were approximately double that reported for currently approved BPH drugs (3-5 points) without the sexual, blood pressure, or other side effects associated with the approved drugs. Follow-up studies have shown durable clinically significant benefit for up to 7 ½ years after a single treatment.

BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.


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Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID^® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).

One of the largest phase III randomized, international studies ever conducted in newly-diagnosed multiple myeloma, MM-020/IFM 07-01 is also known as the FIRST^® (Front-Line Investigation of REVLIMID/Dexamethasone vs. Standard Thalidomide) trial. The international study randomized 1,623 patients who were ineligible for autologous stem cell transplantation to receive continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone and thalidomide for up to twelve 42-day cycles (72 weeks).

The primary endpoint for the study was PFS. Secondary endpoints include overall survival, response rate, quality of life and safety.

The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study are planned to be presented at an upcoming medical meeting.

Based on the results of the FIRST^® study, the Company will commence discussions with regulatory authorities and plans to submit dossiers for registration in the US, Europe and other markets.

These results are from an investigational phase III study. REVLIMID is not approved for the treatment of patients with newly-diagnosed multiple myeloma in any country.


Also Thursday:

Abiomed, Inc. (Nasdaq:ABMD) announced today that on Thursday, August 1, 2013, the Company will release financial results for the first quarter of fiscal 2014.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN)
today announced that the Company will report its financial results for the second quarter ended June 30, 2013 on Thursday, July 25, 2013 before the US financial markets open.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today positive top-line results from its ongoing Phase I trial of ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR).

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fiscal 2013 fourth quarter and full year ended May 31, 2013.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
today announced that the Biomedical Advanced Research and Development Authority (BARDA/HHS) has released funding under the current $234.8 million contract to enable completion of a New Drug Application (NDA) filing for intravenous (i.v.) peramivir.

Biodel Inc. (Nasdaq:BIOD)
today announced that all scheduled follow-up visits have been completed for patients enrolled in the Phase 2 clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy.

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis® (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.

CodeSmart Holdings, Inc. (OTCQB:FICFD)
, with its subsidiary, The CODESMART™ Group, Inc. (collectively, "CODESMART™"), a premier ICD-10 education and solutions group that offers CODESMART™ UNIVERSITY, its on-line education solution and customizable training solutions, today announced a first of its kind ICD-10 pilot program for rural healthcare facilities to extend a best practices and streamlined approach to ICD-10 exclusively for Amerinet members.

Corgenix Medical Corporation (OTC BB: CONX)
, a worldwide developer and marketer of diagnostic test kits, announced today that it has entered into a contract manufacturing agreement with EDP Biotech, a medical device company focused on the development and commercialization of immunodiagnostic tests for humans.

Daxor Corporation, (NYSE MKT: DXR)
announced today that the July, 2013 issue of the journal Clinical Nuclear Medicine (Vol. 38, #7, p 534-540) has published a review article by Dr. Donald Margouleff, MD, FACP, entitled "Blood Volume Determination, A Nuclear Medicine Test in Evolution".

Dynavax Technologies Corporation (NASDAQ: DVAX)
announced today the appointment of Dr. Robert Janssen, M.D. as Chief Medical Officer and Vice President, Clinical Development.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended June 30, 2013 after the market closes on Thursday, July 25, 2013 and will host a conference call at 5:00 p.m. ET that day to discuss its results.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its second quarter 2013 earnings release conference call.

Incyte Corporation (Nasdaq: INCY)
announced today that it has scheduled its second quarter conference call for 8:30 a.m. ET on Thursday, August 1, 2013.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice, will report its financial results for the second quarter ended June 30, 2013 on Thursday, July 25, 2013, after the market close.

Micrel, Inc. (NASDAQ: MCRL)
, an industry leader in high-performance linear and power solutions, LAN and timing and communications solutions, will announce financial results for the second quarter ended June 30, 2013 after the market closes on Thursday, July 25, 2013.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it will co-sponsor the 2013 Alzheimer’s Imaging Consortium on July 13, 2013.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company and provider of natural products and cell and gene therapy solutions for the treatment of diseases, announces today the completion of the acquisition of all of the shares of Bio Blue Bird AG ("BBB"), a wholly-owned subsidiary of SG Austria Private Limited (SGA).

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
reported favorable results from the most recent Safety Monitoring Committee review of ongoing safety data for the Company's NX02-0017 clinical trial, one of the two Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH).

pSivida Corp. (NASDAQ:PSDV)
, a specialty pharmaceutical company that is a leader in developing sustained release drugs for the treatment of back-of-the-eye diseases, today announced interim data from an investigator-sponsored Phase I/II study of pSivida’s injectable micro-insert in patients with posterior uveitis.

OTC Markets Group Inc. (OTCQX: OTCM)
congratulates Organovo Holdings Inc. on its listing on the New York Stock Exchange's NYSE MKT.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR)
today announced its intent to initiate a pilot commercialization effort for H.P. Acthar® Gel (repository corticotropin injection) for the treatment of respiratory manifestations of symptomatic sarcoidosis, a potentially serious, difficult-to-treat disorder already included on the FDA-approved package insert for Acthar.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported that it had commenced dosing in the first of two supplementary pharmacokinetic studies with RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron.

RepliCel Life Sciences Inc. (OTCBB:REPCF) (CNSX:RP)
is pleased to report that it has completed the previously announced Collaboration and Technology Development Transfer Agreement (the "Agreement") with Shiseido Company, Limited ("Shiseido").

Rockwell Medical (NASDAQ: RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, today announced successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP.

Simulations Plus, Inc. (NASDAQ:SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, reported financial results for its third quarter of fiscal year 2013, the period ended May 31, 2013 (3QFY13).

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that the Company will release 2013 second quarter financial results before market open on Wednesday, July 24, 2013.

VIVUS, Inc. (Nasdaq:VVUS)
, a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today reiterated its recommendation that all stockholders vote "FOR" the Company's director nominees at VIVUS's Annual Meeting of Stockholders, which will be held on July 15, 2013.

First Manhattan Co., the owner of approximately 9.9% of the outstanding shares of VIVUS, Inc. (Vivus) (NASDAQ: VVUS), today issued an open letter to Vivus' shareholders.




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