Navigation Links
Algeta Receives IND Approval for Alpharadin(TM) to Commence Clinical Development in the USA
Date:2/21/2008

OSLO, February 21 /PRNewswire-FirstCall/ -- Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead product Alpharadin(TM) with the United States Food and Drug Administration (FDA) in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application. Alpharadin(TM) has already been studied in phase II clinical trials in Europe and has demonstrated a potential for a significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.

An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York, one of the world's leading oncology centers. This US trial will further expand the information obtained in a similar phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.

Following the start up of the BC1-08 trial, Algeta will continue discussions with the FDA to agree on the design of the further clinical development program for Alpharadin(TM)

"We are delighted to have been given the clearance by FDA to advance Alpharadin into clinical development in the United States, and to be working with one of the world's leading cancer centers on our clinical program," said Dr. Thomas Ramdahl, President and CEO of Algeta. "There is a great unmet medical need among men suffering from HRPC with skeletal metastases and the opening of this US clinical trial will be an important step in our overall clinical development of Alpharadin. As earlier announced, we plan to initiate an international pivotal phase III clinical trial with Alpharadin in HRPC patients during the first half of 2008."

About Algeta

Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta's lead product candidate, Alpharadin, is planned to enter Phase III clinical trials in hormone refractory prostate cancer before mid 2008 based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.


'/>"/>
SOURCE Algeta
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
2. DaVita Receives Civil Complaint
3. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
4. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
5. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
6. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
7. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
8. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
9. Prime Therapeutics Receives TIPPS Certification
10. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
11. UCLA receives $22.5 million to explore the fundamental biology of mental disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology: