RxPG News Feed for RxPG News

Medical Research Health Special Topics World
  Home
 
   Health
 Aging
 Asian Health
 Events
 Fitness
 Food & Nutrition
 Happiness
 Men's Health
 Mental Health
 Occupational Health
 Parenting
 Public Health
 Sleep Hygiene
 Women's Health
 
   Healthcare
 Africa
 Australia
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 UK
 USA
 World Healthcare
 
   Latest Research
 Aging
 Alternative Medicine
 Anaethesia
 Biochemistry
 Biotechnology
 Cancer
  Bladder
  Blood
  Bone Cancer
  Brain
   Glioblastoma Multiforme
   Medulloblastoma
  Breast Cancer
  Carcinogens
  Cervical Cancer
  Colon
  Endometrial
  Esophageal
  Gastric Cancer
  Liver Cancer
  Lung
  Nerve Tissue
  Ovarian Cancer
  Pancreatic Cancer
  Prostate Cancer
  Rectal Cancer
  Renal Cell Carcinoma
  Risk Factors
  Skin
  Testicular Cancer
  Therapy
  Thyroid
 Cardiology
 Clinical Trials
 Cytology
 Dental
 Dermatology
 Embryology
 Endocrinology
 ENT
 Environment
 Epidemiology
 Gastroenterology
 Genetics
 Gynaecology
 Haematology
 Immunology
 Infectious Diseases
 Medicine
 Metabolism
 Microbiology
 Musculoskeletal
 Nephrology
 Neurosciences
 Obstetrics
 Ophthalmology
 Orthopedics
 Paediatrics
 Pathology
 Pharmacology
 Physiology
 Physiotherapy
 Psychiatry
 Radiology
 Rheumatology
 Sports Medicine
 Surgery
 Toxicology
 Urology
 
   Medical News
 Awards & Prizes
 Epidemics
 Launch
 Opinion
 Professionals
 
   Special Topics
 Ethics
 Euthanasia
 Evolution
 Feature
 Odd Medical News
 Climate

Last Updated: Oct 11, 2012 - 10:22:56 PM
Brain Channel

subscribe to Brain newsletter
Latest Research : Cancer : Brain

   EMAIL   |   PRINT
Regulatory Approval for New Cotara(R) Brain Cancer Clinical Trial

Oct 13, 2006 - 1:17:00 AM , Reviewed by: Priya Saxena
"We are moving this program forward in India because of the high level of experience of the participating neurosurgeons with CED delivery, the state-of-the-art facilities of the medical centers involved and the fact that the contract research organization overseeing the trial is highly experienced in successfully running similar glioblastoma trials with many of the investigators who will be involved with our study."

 
[RxPG] Peregrine Pharmaceuticals, a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of cancer and hepatitis C virus infection, today announced that it has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara(R). The trial is designed to test the safety and efficacy of Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer. Cotara is currently being studied in a multi-center U.S. glioblastoma trial. Previous studies using Cotara to treat brain cancer have produced encouraging results, and Peregrine expects that positive data from this trial in combination with data from the ongoing U.S. clinical trial should provide the foundation for planning the future development and commercialization of Cotara.

The new safety and efficacy study is expected to be an integral part of Peregrine's overall Cotara brain cancer development program. It will be conducted according to internationally accepted ICH GCP guidelines at up to seven clinical centers and is expected to enroll up to 40 patients with glioblastoma who have experienced their first relapse. Patients will receive a single infusion of the drug by convection-enhanced delivery (CED), an NIH-developed technique in which the drug is slowly administered directly into the glioblastoma tumor with great precision. The primary endpoints of the trial are to confirm safety and determine median survival time and median time to progression in Cotara-treated patients. Patient enrollment in the study is expected to be completed by the end of 2007.

"We believe this new clinical trial will be a cornerstone of our future plans to develop Cotara for the treatment of this deadly form of cancer," said Steven W. King, president and CEO of Peregrine. "We are moving this program forward in India because of the high level of experience of the participating neurosurgeons with CED delivery, the state-of-the-art facilities of the medical centers involved and the fact that the contract research organization overseeing the trial is highly experienced in successfully running similar glioblastoma trials with many of the investigators who will be involved with our study."

Mr. King added, "We have previously generated encouraging results using Cotara in this lethal cancer, and this study should allow us to evaluate the potential of the drug to extend patient survival more rapidly than we had originally anticipated. The new trial aims to provide clinical data in a timely manner that can be combined with the dosimetry and safety data we will be gathering from the ongoing U.S. study to guide the further clinical and commercial development of Cotara. We believe this trial could greatly expedite our Cotara brain cancer program based on the fact that some of the cancer centers we are working with routinely treat thousands of brain cancer patients each year, while major U.S. centers typically treat at most several hundred."

Global pharmaceutical companies including Pfizer, GlaxoSmithKline, Roche and Eli Lilly have been conducting an increasing number of major clinical trials in India in recent years, taking advantage of the country's world-class clinical research facilities that leverage India's large cadre of Western-trained medical personnel and enormous pool of patients eager to participate in clinical trials.

Cotara is an experimental new treatment for brain cancer that links a radioactive substance designed for medical uses -- a radioactive isotope -- to a targeted monoclonal antibody. This monoclonal antibody is designed to bind to a type of DNA that is exposed only on dead and dying cells. Solid tumors, including brain tumors, have a significant number of dead and dying cells at their center, and Cotara's targeting mechanism enables it to home in on these dying tumor cells, delivering its radioactive "payload" directly to these cells at the center of the tumor mass. Cotara thus literally destroys the tumor "from the inside out" with minimal radiation exposure to healthy tissue.

Cotara is delivered through a special method called convection-enhanced delivery (CED). CED uses a catheter to bypass the blood brain barrier and target the specific tumor site in the brain, directing Cotara to the tumor more precisely. This type of delivery has been shown to achieve up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimizing unwanted exposure.

In previous clinical studies Cotara has demonstrated encouraging results in a number of patients with advanced brain cancer. One study demonstrated a greater than 50% increase in median survival time in a group of patients suffering from late stage glioblastoma multiforme who were treated with Cotara. This was considered a promising development in this serious and deadly disease. Cotara is currently in a multi-center dosimetry and dose confirmation trial in glioblastoma patients being conducted by the New Approaches to Brain Tumor Therapy (NABTT), a consortium of leading U.S. academic brain cancer centers. Cotara has been granted orphan drug status and fast track designation by the U.S. Food and Drug Administration for the treatment of glioblastoma multiforme.



Publication: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM)
On the web: www.peregrineinc.com 

Advertise in this space for $10 per month. Contact us today.


Related Brain News
Signaling pathway discovered which may help find treatment for glioblastoma multiforme
Electronic nose potent new weapon against brain cancer
Neuroblastoma treatment- adding tumor-specific receptor to cytotoxic T cells with EBV receptor
Significant vaccine-enhanced immune response in malignant brain tumour
Simultaneous implantation of radioactive seeds and chemotherapy wafers promising in glioblastoma multiforme treatment
KetoCal diet: A non-invasive way to deal with malignant brain cancers
Bevacizumab holds promise for gliomas
'Gateway' gene discovered for brain cancer
Regulatory Approval for New Cotara(R) Brain Cancer Clinical Trial
Lead exposure linked with brain cancer

Subscribe to Brain Newsletter

Enter your email address:


 Additional information about the news article
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing five separate clinical trials in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R) in the U.S. and India. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the Company will not be able to enroll a sufficient number of patients to complete the clinical study, the risk that enrollment will be slower than expected, the risk that the results from the clinical study will not be consistent with the results from previous clinical studies of Cotara and the uncertainties associated with conducting clinical studies in, and complying with the regulatory requirements of, India. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
 Feedback
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 
Contact us

RxPG Online

Nerve

 

    Full Text RSS

© All rights reserved by RxPG Medical Solutions Private Limited (India)