Navigation Links
FDA Approves the Opening of a Phase II Registration Protocol Using REXIN-G(R) for Osteosarcoma in California U.S.A.
Date:11/5/2007

SAN MARINO, Calif., Nov. 5 /PRNewswire/ -- Epeius Biotechnologies Corporation announced today that the company has taken a major step toward the commercialization of its lead product with the opening of a Phase II Registration Protocol using Rexin-G for osteosarcoma in the United States. Following the accelerated approval of Rexin-G for the treatment of all solid tumors by the Bureau of Food and Drugs in the Philippines, Epeius opened a number of Phase I/II clinical trials in the United States for pancreatic cancer, breast cancer and all types of sarcoma in the summer of 2007.

*(LOGO: Send2Press.com/mediaboom/logo-epeius_72dpi.jpg)

Based on the exceptional safety profile of Rexin-G in the first 18 patients who participated in these U.S.-based clinical trials, and the profound demonstration of single agent efficacy in metastatic osteosarcoma, the FDA approved a Phase II Registration Protocol using intravenous Rexin-G for recurrent or metastatic osteosarcoma that is refractory to known therapies. The study will recruit 20-30 patients in 12-18 months. Children who are at least 10 years of age or older are eligible to participate in the study. The adaptive trial design of this advanced Phase II registration protocol incorporates (i) a dosing schedule based on the patient's estimated tumor burden and not on standard dosing per kilogram body weight or body surface area, and (2) a tumor response evaluation process that is unique to the manner in which osteosarcoma responds favorably to therapy, i.e., with necrosis and increasing calcification in metastatic tumors and decreased glucose utilization using PET-CT imaging studies.

Rexin-G is a tumor-targeted gene medicine that seeks out and destroys both primary tumor and metastatic cancers that have spread throughout the body. Delivered by simple intravenous infusion, Rexin-G has demonstrated unprecedented single-agent efficacy against a broad spectrum of solid tumors where chemotherapy, radiotherapy a
'/>"/>

SOURCE Epeius Biotechnologies Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... 26, 2014 Recently, Dylan Queen, a ... excitedly released its collection of discounted prom dresses, most ... a senior spokesman of the company, the promotion is ... promotion is to expand the UK market. , The ... different colors, lengths, and styles: A-line strapless, empire strapless ...
(Date:12/25/2014)... 2014 BambooFlooringChina.com sells many bamboo products ... flooring. Today, the company announces big discounts on ... and colors. , BambooFlooringChina.com is the world’s leader in ... is valid until Jan. 20, 2015. , The bamboo ... with a natural thread. All the bamboo strips for ...
(Date:12/25/2014)... 2014 Recently, LunaDress.co.uk has updated its blog to ... accessories. Now, all of the models at LunaDress.co.uk come with big ... lifts the wedding veil can turn out to be a most ... wedding veil can always bring surprise to a wedding. On the ... to choose veils for a big day . , Going ...
(Date:12/25/2014)... 2014 (HealthDay News) -- Overeating is common during the holidays, ... moderation, an expert says. "Don,t arrive at a party ... you know you,ll be attending a party, but deprivation leads ... dietitian at Northern Westchester Hospital in Mount Kisco, N.Y., said ... healthy during the day and even to have a snack ...
Breaking Medicine News(10 mins):Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2
... to the,devastating 7.9 magnitude earthquake that hit China,s ... corporations have generously supported,American Red Cross relief efforts, ... the outpouring of compassion,we,ve received from individuals and ... vice president, International Services for the,American Red Cross. ...
... of life, cut need for 2nd treatment , , ... of patient satisfaction and low rates of re-surgery ... (GERD) who had minimally invasive laparoscopic fundoplication (anti-reflux ... U.S. study. , Studies have shown the ...
... - Bioniche Life Sciences,Inc. (TSX: BNC), ... two presentations made by its,researchers at ... to the Annual Meeting of the ... Life Sciences Inc. was among the ...
... special ultrasound technique to spot areas of blood flow ... of unnecessary biopsies, according to a new study by ... and the Kimmel Cancer Center at Jefferson in Philadelphia. ... increased blood flow in the prostate were twice as ...
... fracture risk and increases density, study finds, , , FRIDAY, May ... been associated with poor bone health, a new review suggests ... actually have stronger bones that are less prone to fractures. ... a 20 percent reduced risk of hip fracture compared to ...
... With the anticipated opening,of a new facility in 2012 ... Hospital for Children. The announcement was made today,as part ... in support of the,pediatric medical center,s proposed expansion facility., ... in support of,Children,s Hospital. The gift, the largest in ...
Cached Medicine News:Health News:America Generously Responds to China Earthquake 2Health News:Patients Pleased With Laparoscopic GERD Surgery 2Health News:Bioniche Presents Pre-Clinical Research at Two International Conferences 2Health News:Bioniche Presents Pre-Clinical Research at Two International Conferences 3Health News:Monitoring blood flow helps improve prostate biopsies, Jefferson researchers report 2Health News:Light Alcohol Consumption May Help Bones 2Health News:Light Alcohol Consumption May Help Bones 3Health News:Children's Hospital Campus to be Renamed Thanks to Transformational Capital Gift 2Health News:Children's Hospital Campus to be Renamed Thanks to Transformational Capital Gift 3Health News:Children's Hospital Campus to be Renamed Thanks to Transformational Capital Gift 4
(Date:12/24/2014)... International Trade Commission (ITC) issued its final decision in the ... notice issued on December 23, the ITC ruled in favor ... was invalid. BMC President, James Xu ... with the ITC,s decision in this case. This victory for ... very beginning on the key patents in the case. ResMed ...
(Date:12/24/2014)... LONDON , December 24, 2014 /PRNewswire/ ... expected to grow at an average rate of 8.1%. ... and volume. Hip, knee and spine surgeries are the ... emerging economies they have a lower penetration. Increased number ... use of composites. Non-metallic orthopedic devices have gained popularity ...
(Date:12/24/2014)... SAN DIEGO , Dec. 23, 2014 ResMed ... a significant patent infringement action against Chinese medical device manufacturer ... Commission (ITC) ruled today that BMC,s masks listed below infringe ... advertising, or selling these masks in the United ... , iVolve N2 nasal mask , Willow nasal pillows ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3ResMed Wins Patent Infringement Lawsuit Against Chinese Manufacturer BMC Medical 2
... Aug. 8, 2011 Symphony Corporation, a global ... of JGI, a New Jersey-based Human Capital Management ... in the healthcare industry nationally.  Symphony,s acquisition of ... to provide the highest level of benefits to ...
... 2011 Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL ... James P. Tursi has been promoted to Chief Medical ... Executive Officer and President of Auxilium, and sit on ... (Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO) Dr. Tursi has been ...
Cached Medicine Technology:Symphony Corporation Acquires JGI to Provide End-to-End Services for Healthcare IT 2Auxilium Pharmaceuticals, Inc. Announces Promotion of Dr. James P. Tursi to Chief Medical Officer 2Auxilium Pharmaceuticals, Inc. Announces Promotion of Dr. James P. Tursi to Chief Medical Officer 3
The MULTI-LINK ZETA Coronary Stent System utilizes the same clinically proven implant as the MULTI-LINK PENTA Coronary Stent System, maintaining the benefits of a 17.5% binary restenosis rate....
Now available in 2.75-mm diameters, the S660 small vessel coronary stent expands your treatment options for accurate sizing and precision stenting....
The MULTI-LINK PIXEL Coronary Stent System was designed to address the challenges of small vessel treatment in patients with abrupt or threatened abrupt closure (ATC)....
FemoStop system is a femoral compression system for hemostasis management. It provides a comfortable and efficient "hands off method of compressing the femoral artery and vein after diagnostic and i...
Medicine Products: