OncoGenex Announces Initiation of the Phase 3 "AFFINITY" Trial; Nektar Announces Initiation of NKTR-102 Print E-mail
By Staff and Wire Reports   
Tuesday, 07 August 2012 20:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 7, 2012.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
announced it has initiated patient enrollment in its second Phase 3 clinical trial evaluating custirsen in patients with advanced prostate cancer. The AFFINITY trial will evaluate if custirsen when combined with second-line chemotherapy has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone.

This Phase 3 trial is an international, randomized, open-label study that will enroll approximately 630 men with CRPC who received first-line docetaxel chemotherapy and have disease progression. Patients will be randomized to receive custirsen, cabazitaxel and prednisone or cabazitaxel and prednisone alone. The primary endpoint of the study is overall survival. Additional analyses will evaluate disease progression parameters and quality of life.


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Nektar Therapeutics (NASDAQ: NKTR)
announced today the start of a Phase 2 study of etirinotecan pegol in patients with bevacizumab (Avastin)-resistant high-grade glioma being conducted at Stanford Cancer Institute. The Phase 2 study is an investigator-sponsored trial being conducted under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigators Seema Nagpal, M.D. and Pamela Kunz, M.D.



Also Tuesday:



Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that the United States Patent and Trademark Office has granted a patent for the use of its oral ghrelin agonist, AEZS-130 (EP1572) as a diagnostic test for adult growth hormone deficiency (AGHD).

AspenBio Pharma, Inc. (Nasdaq: APPY)
, an in vitro diagnostic company, announced that it has submitted a pre-IDE (Investigational Device Exemption) information package to the U. S. Food and Drug Administration (FDA) for the use of the AppyScore™ test system to aid physicians in evaluating children and young adult patients at low risk for acute appendicitis, allowing for more conservative patient management.

Astro-Med, Inc. (NASDAQ: ALOT)
, a manufacturer of high tech specialty printers, test and measurement systems, and electronic medical instrumentation, will announce its financial results for the Second Quarter ended July 28, 2012 on August 21, 2012.

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced that company management will present an overview of the company at the following investor conferences in August.

Biostem U.S., Corporation (OTCQB: HAIR) (PINKSHEETS: HAIR)
(Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced the appointment of Marina Pizarro, M.D. to its Scientific and Medical Board of Advisors (SAMBA). Chief Executive Officer Dwight Brunoehler stated, "The addition of Dr. Pizarro to Scientific and Medical Board of Advisors rounds out our team with expertise in the field of hair re-growth using stem cells.

Eli Lilly and Company (NYSE: LLY)
today announced data from a Phase III trial comparing the effects of FORTEO® (teriparatide [rDNA origin] injection) and risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced financial results for the three and six months ended June 30, 2012.

Epistem (AIM:EHP)
, the biotechnology and personalised medicine company, has announced that it has reached agreement with Becton Dickinson (BD) for the supply and distribution of its Mycobacterium tuberculosis (TB) test on a global basis (excluding India and the Indian Sub Continent) using its Genedrive™ platform.

Insmed Incorporated (Nasdaq CM: INSM)
, a biopharmaceutical company dedicated to the development of innovative inhaled pharmaceuticals for the treatment of serious lung infections, today reported results for the second quarter and six-months ended June 30, 2012.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the 32nd Annual Canaccord Global Growth Conference at the InterContinental Boston. Management is scheduled to present an overview of the Company on Tuesday, August 14, 2012 at 3:30 p.m. ET.

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced that a conference call will be held on Wednesday, August 8, 2012 at 8:30 a.m. EDT to discuss results for the second quarter ended June 30, 2012 and a business outlook for the remainder of 2012.

MiMedx Group, Inc. (OTCBB: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has closed a clinical trial involving its EpiFix® dehydrated human amniotic membrane allograft for the treatment of diabetic neurovascular foot ulcers.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
announced today that it has initiated patient enrollment in its second Phase 3 clinical trial evaluating custirsen in patients with advanced prostate cancer.

Organovo Holdings, Inc. (OTCQB: ONVO)
, the San Diego-based regenerative medicine company focused on using its breakthrough NovoGen 3D human tissue printing technology to create tissue on demand for research and surgical applications, today announced that their August 2nd Retail Investor Conferences.com presentation is now available for on-demand viewing.

Origin Agritech Limited (NASDAQ: SEED)
("Origin" or the "Company") , a technology-focused supplier of hybrid and genetically modified crop seeds in China, today announced unaudited financial results for the third quarter ended June 30, 2012.

Royal Philips Electronics (NYSE: PHG) (AEX: PHI)
and Celsion Corporation (NASDAQ: CLSN) today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion's ThermoDox® combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
, an emerging leader in the vertical and Local search space, today announced that it will release its financial results for the first six months of 2012 after the market close on August 21st.



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