Navigation Links
Results From Phase 1 Clinical Study of PEG-PAL in PKU and Update on Phase 2 Clinical Study
Date:6/9/2009
NOVATO, Calif., June 9 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced results from the Phase 1 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). The company expects to initiate the Phase 2 clinical study in late June or early July, pending institutional review board (IRB) approval from the clinical trial sites. The U.S. Food and Drug Administration (FDA) has reviewed the Phase II clinical trial protocol.
Key findings from the Phase 1 study:
- Substantial blood Phe level reductions in the range of 36% to 97% (mean of 62%) were observed in all patients in the fifth dosing cohort (0.1 mg/kg) with a mean baseline blood Phe level of 1113 umol/L. No notable blood Phe level reductions were observed in the first four dosing cohorts (0.001 to 0.03 mg/kg).
- No serious immune reactions, including hives or anaphylactoid reactions, were observed.
- Seven out of 25 patients developed late mild to moderate injection-site reactions, of which two also developed skin rashes without other symptoms and two patients developed reactions to Depo-Provera (medroxyprogesterone acetate).
"We are encouraged to see significant reductions in blood Phe levels in all patients in the fifth dosing cohort of the Phase 1 trial. Importantly, there were no serious reactions, and both the number and severity of the mild to moderate reactions were in-line with expectations of an enzyme of this nature," said Hank Fuchs, M.D., Chief Medical Officer of BioMar
'/>"/>
| SOURCE BioMarin Pharmaceutical Inc. Copyright©2009 PR Newswire. All rights reserved |
Related medicine news :
1. Haemacure Reports Third Quarter 2007 Results
2. Brooke Franchise Corporation Announces Selected July Results
3. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
4. Somanetics Corporation to Release Third Quarter 2007 Financial Results and Host Conference Call September 19
5. The New England Journal of Medicine Publishes EURIDIS/ADONIS Study Results Showing Dronedarone Maintained Sinus Rhythm in Patients With Atrial Fibrillation or Flutter With no Observed Pro-Arrhythmia
6. NBTY Announces Preliminary Unaudited Net Sales Results For August 2007
7. Martek Announces Third Quarter 2007 Financial Results
8. MDS Reports Third Quarter 2007 Results
9. Authentidate Holding Corp. to Report Fourth Quarter and Fiscal 2007 Year End Results on Thursday, September 13, 2007
10. Robbins & Myers to Release Fourth Quarter and 2007 Fiscal Year Results on Monday, October 15, 2007
11. NMHC Reports Fourth Quarter and Fiscal Year 2007 Financial Results
Post Your Comments:
(Date:5/24/2013)... News) -- The number of U.S. patients admitted ... in an emergency room has increased by nearly ... study, conducted by researchers at the George Washington ... in Washington, D.C., found that patients wait five ... being admitted to the ICU. The researchers said ...
(Date:5/24/2013)... Bay, Australia (PRWEB) May 24, 2013 ... show off their favorite sunglasses all while learning ... longer with replacement lenses. Contestants only need ... wearing their sunglasses and "like" The Sunglass Fix ... winning Sunglass fix is the largest lens ...
(Date:5/24/2013)... aortic valve implantation (TAVI) is effective and safe in ... results from a multicentre Asian registry reported at EuroPCR ... a treatment option for selected patients with symptomatic severe ... North American or European centres," Paul Chiam, senior consultant ... conference. He explained that it is unknown whether the ...
(Date:5/24/2013)... In a coup that surely made other ... of the Estetica Institute of the Palm Beaches performed eye ... popular morning show, “The Mo & Sally Morning Show.” The ... satisfaction with the results, giving Dr. DeLange and the team ... Beach Gardens, very valuable free publicity. , Dr. DeLange, the ...
(Date:5/24/2013)... 2013 CBT News.com recently announced the addition ... web-based retail automotive industry news organization with 12 years experience ... to join a group that’s so forward-thinking in their approach,” ... online video content is on the rise.” , Atlanta born ... and segued into advertising at Cycle News and Boating World. ...
Breaking Medicine News(10 mins):Health News:Sharp Rise in ICU Admissions From U.S. Emergency Rooms 2Health News:Break the Sunglass Mold – Reuse 'Em, Don’t Toss 'Em then Enter the SunglassFIX Photo Contest to Win 2Health News:Registry confirms TAVI efficacy and safety in Asian patients 2Health News:Dr. Greg DeLange of the Estetica Institute Recently Performed Eye Surgery on Both Members of Popular Morning Radio Team 2[0] Sharp Rise in ICU Admissions From U.S. Emergency Rooms [0] Break the Sunglass Mold – Reuse 'Em, Don’t Toss 'Em then Enter the SunglassFIX Photo Contest to Win[0] Registry confirms TAVI efficacy and safety in Asian patients[0] Dr. Greg DeLange of the Estetica Institute Recently Performed Eye Surgery on Both Members of Popular Morning Radio Team[0] Tom Gonter to Drive Sales at Retail Automotive News Organization CBT News
... HealthDay Reporter , WEDNESDAY, July 27 (HealthDay News) ... emotional or behavioral issues often face tough social and ... , Tracking the progress of more than 1,450 students ... U.S. researchers found that one-third coped with special health ...
... research out of UCLA has found that Latinos living in ... the country are far less likely to spend for ... they do spend than the white population. ... they stay in the country, spending disparities remain large over ...
... discoveries in the field of cognitive neuroscience hold great ... a significant gap between such scientific discoveries and the ... New York Academy of Sciences and the ... conference on September 22-24, 2011 in Aspen, Colorado, ...
... BROOK, Ill. (July, 27, 2011) Using computed tomography (CT), ... lungs of patients with chronic obstructive pulmonary disease (COPD) that ... worsen. Their findings are published online in the journal ... the air sacs of the lungs, and is a leading ...
... risk factor for COPD, but have not accounted for ... Women,s Hospital, the University of Colorado, and National Jewish ... from the COPD Gene Study, capturing parental smoking and ... findings noted a strong risk factor for COPD when ...
... Brigham and Women,s Hospital (BWH) uses a new imaging technique, ... that are activated when patients with low back pain have ... published in the August issue of the journal Anesthesiology ... providing tools to objectively describe someone,s chronic pain which is ...
Cached Medicine News:Health News: Special Needs Kids Bullied More, Fare Poorly at School 2Health News: Special Needs Kids Bullied More, Fare Poorly at School 3Health News:Big gap exists on health care spending between Latinos and whites, study finds 2Health News:Conference: Improving K-12 education with cutting-edge cognitive neuroscience research 2Health News:CT shows changes in lungs associated with COPD flare-ups 2Health News:New imaging technique captures brain activity in patients with chronic low back pain 2 Special Needs Kids Bullied More, Fare Poorly at SchoolBig gap exists on health care spending between Latinos and whites, study findsConference: Improving K-12 education with cutting-edge cognitive neuroscience research CT shows changes in lungs associated with COPD flare-upsFamily history a risk factor for COPDNew imaging technique captures brain activity in patients with chronic low back pain
(Date:5/23/2013)... y PARÍS, 24 de mayo de ... ), un destacado desarrollador y fabricante de herramientas ... la diagnosis y tratamiento de la enfermedad vascular ... del ensayo ADVISE ( Ad enosine V ... E valuation) II durante la sesión de ensayo ...
(Date:5/23/2013)... 23, 2013 Amgen (NASDAQ: AMGN ) ... Healthcare Conference on Thursday, May 30, 2013, at the Westin ... 9:20 a.m. Eastern Daylight Time. Arvind Sood ... at the conference. Live audio of the presentation can be ... , under Investors. A replay of the webcast will also ...
(Date:5/23/2013)... May 23, 2013 Nephros, Inc. (OTC Bulletin ... device company that develops and sells high performance liquid ... rights offering. In addition, the concurrent temporary reduction in ... on May 17, 2013. Nephros estimates that ... the rights offering. A portion of the proceeds will ...
Breaking Medicine Technology:Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6Nephros Announces Completion of Rights Offering 2Nephros Announces Completion of Rights Offering 3Nephros Announces Completion of Rights Offering 4... , CRANBURY, N.J. , Feb. 1 ... producer in North America , today announced that it will host ... 10:00 am ET to discuss its fourth quarter and full ... will be issued on Wednesday, February 17, 2010 after market ...
... , , ... , WHAT: Each February, the American Dental Association (ADA) ... importance of oral health. Developing good habits at an early age ... on a lifetime of healthy teeth and gums. , (Logo: ...
Cached Medicine Technology:Innophos Holdings, Inc. Schedules Call to Discuss Fourth Quarter and Full Year 2009 Results 2Innophos Holdings, Inc. Schedules Call to Discuss Fourth Quarter and Full Year 2009 Results 3February is National Children's Dental Health Month -- 'Remember to Brush and Floss Every Day' is the Message -- Kids With Braces Need to be Extra Vigilant 2February is National Children's Dental Health Month -- 'Remember to Brush and Floss Every Day' is the Message -- Kids With Braces Need to be Extra Vigilant 3Anterior Chamber Needle, 30 g. Angled. 5 mm angled tip. Overall length 20 mm. 5/box....
Anterior Chamber Needle, 23 g. Angled. 7 mm angled tip. Overall length 23 mm. 5/box....
Anterior Chamber Needle, 20 g. Angled. 7 mm angled tip. Overall length 23 mm. 5/box....
Hydrodissection / Aspiration Cannula, 25 g. Angled with right hook. 10 mm angled shaft with 2.5 mm right hook tip. Overall length 20 mm. 5/box....
Medicine Products:| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |