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PKCiota oncogene essential for lung cancer stem cell proliferation

Scientists at the Mayo Clinic campus in Florida have found that the lung cancer oncogene PKCiota is necessary for the proliferation of lung cancer stem cells. These stem cells are rare and powerful master cells that manufacture the other cells that make up lung tumors and are resistant to chemotherapy treatment.

9 Sep 2009

New procedure for transapical valve replacement minimizes trauma and blood loss

Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system, designed to benefit both patients and physicians by minimizing trauma and blood loss, and facilitating transcatheter heart valve delivery and deployment.

9 Sep 2009

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S.

8 Sep 2009

Protalix receives orphan drug designation for prGCD

Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company’s proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

8 Sep 2009

Fourth-quarter and fiscal year end 2009 results announced by Palatin Technologies

Palatin Technologies, Inc. (NYSE Amex: PTN) today announced results for its fourth quarter and fiscal year ended June 30, 2009. For the year ended June 30, 2009, total revenues were $11.4 million, compared to $11.5 million for year ended June 30, 2008. Palatin's net loss for the year ended June 30, 2009 was $4.8 million, or $(0.06) per basic and diluted share, compared to a net loss of $14.4 million, or $(0.17) per basic and diluted share, for the year ended June 30, 2008.

8 Sep 2009

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.

8 Sep 2009

Patient enrollment for Phase 2b study of PRX302 completed by Protox Therapeutics

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has completed patient enrollment in its multi-centre, double-blinded, placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide.

8 Sep 2009

Third human clinical trial of LigoCyte's norovirus vaccine started

LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo.

8 Sep 2009

Lupus Foundation of America takes steps to address shortage of participants for clinical trial

It has been more than 50 years since the U.S. Food and Drug Administration (FDA) last approved a new medicine specifically for lupus – when Dwight D. Eisenhower was president. Existing treatments have been "borrowed" from other disorders and the risk/benefit ratio of these treatments is far from optimal. However, hope is on the horizon.

8 Sep 2009

Recruitment for the Phase IIa clinical trial to assess CNS 7056 sedative completed by PAION

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces the successful completion of the Recruitment for the Phase IIa clinical trial assessing the new short-acting intravenous anesthetic/sedative CNS 7056 in patients undergoing endoscopy of the upper gastrointestinal tract.

8 Sep 2009

$geneX combined with Mesenchymal stem cells for treating fracture$

geneX combined with Mesenchymal stem cells for treating fracture

Professor James B. Richardson of the Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, UK has been carrying out pioneering work combining geneX with selected and culture expanded Mesenchymal stem cells to treat fracture non-unions.

7 Sep 2009

Identifying a specific molecular signature can help customize cancer treatment

A molecular signature that helps account for the aggressive behavior of a variety of cancers such as pancreatic, breast and melanoma may also predict the likelihood of successful treatment with a particular anti-cancer drug. The finding, which could lead to a personalized approach to treatment for a variety of solid tumors that are currently resistant to therapies, will be published September 6 in the advance online edition of Nature Medicine.

7 Sep 2009

The Jordanian Stem Cell Company signs purchase agreement with Stemedica International

Stemedica Cell Technologies, Inc., ("Stemedica"), a world leader in stem cell research and manufacturing, announced the signing of an agreement today for its breakthrough stem cell and related technology. The Jordanian Stem Cell Company has signed a five year multi-million dollar agreement to purchase the technology from Stemedica's wholly-owned subsidiary, Stemedica International, S.A.

7 Sep 2009

Taskforce formed to help speed licensure, vaccine distribution following RTS,S trials

GNA/Peace FM examines the recent creation of a local and international taskforce to help shorten the window of time between the completion of the clinical trial of the RTS,S malaria vaccine - currently being tested across Africa - and licensure and vaccine distribution. According to the news service, scientists recently launched a Phase III trial of the RTS,S vaccine in Kintampo, Ghana, which will include 1,200 children, between the ages of 6-12 weeks and 5-17 months.

5 Sep 2009

Sinovac to purchase H1N1 vaccine for the national stockpiling plan

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the Ministry of Industry and Information Technology of the People's Republic of China has issued the initial order to Sinovac to purchase H1N1 vaccine for the national stockpiling plan.

5 Sep 2009

Clinical trial of Cerebroprotein Hydrolysate for Injection completes

Hard to Treat Diseases (the "Company") announced today, that its China based subsidiary Mellow Hope, has just finished (August 2009) the clinical trial of Cerebroprotein Hydrolysate for Injection (Brand name: NUTRIPROTEIN) in India.

5 Sep 2009

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

Human Genome Sciences, Inc. today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index selected as the primary endpoint of two pivotal Phase 3 clinical trials of BENLYSTA (belimumab) in serologically active patients with SLE.

4 Sep 2009

Dilafor Phase II clinical trial completes

Karolinska Development (publ) today announced that one of its portfolio companies, Dilafor AB, has concluded an extensive clinical study of its candidate drug, tafoxiparin, a new drug substance for the prevention of protracted labor during childbirth.

4 Sep 2009

OSI Pharmaceuticals initiates two clinical trials with OSI-906 oral insulin-like growth factor-1 receptor inhibitor

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today the initiation of two clinical trials with OSI-906, the Company’s potential first-in-class, oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The first study is a Phase III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC).

4 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

Clinical Trial News and Research

PKCiota oncogene essential for lung cancer stem cell proliferation

New procedure for transapical valve replacement minimizes trauma and blood loss

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

Protalix receives orphan drug designation for prGCD

Fourth-quarter and fiscal year end 2009 results announced by Palatin Technologies

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

Patient enrollment for Phase 2b study of PRX302 completed by Protox Therapeutics

Third human clinical trial of LigoCyte's norovirus vaccine started

Lupus Foundation of America takes steps to address shortage of participants for clinical trial

Recruitment for the Phase IIa clinical trial to assess CNS 7056 sedative completed by PAION

geneX combined with Mesenchymal stem cells for treating fracture

Identifying a specific molecular signature can help customize cancer treatment

The Jordanian Stem Cell Company signs purchase agreement with Stemedica International

Taskforce formed to help speed licensure, vaccine distribution following RTS,S trials

Sinovac to purchase H1N1 vaccine for the national stockpiling plan

Clinical trial of Cerebroprotein Hydrolysate for Injection completes

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

Dilafor Phase II clinical trial completes

OSI Pharmaceuticals initiates two clinical trials with OSI-906 oral insulin-like growth factor-1 receptor inhibitor

Phase III clinical trial results of XIAFLEX published in a journal

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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