Cell Therapeutics Study Achieved Endpoint Trial; Peregrine Shares Higher in Advancing Cotara Program Print
By Staff and Wire Reports   
Wednesday, 05 December 2012 20:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 5, 2012.

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC)
reported on interim results from a cooperative group sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer that were presented at the San Antonio Breast Cancer Symposium (SABCS) held from December 4-8, 2012.

The study enrolled women with confirmed measurable metastatic disease and triple negative subtype breast cancer. At the time of data analysis, 48 women had been enrolled in the study and 47 were evaluable for efficacy. Approximately half of the patients had received between two and four prior chemotherapy regimens in the metastatic setting. The primary endpoint of the trial is 3-month progression-free survival (PFS). Secondary endpoints include overall response rate (ORR), duration of response, 6-month PFS, overall survival (OS) and safety. In this study, patients received cisplatin on Day 1, brostallicin on Day 2, and GCSF or pegylated-GCSF on Day 3, with the cycle repeated every 21 days. The study is led by principal investigator Dr. Alvaro Moreno-Aspitia, Assistant Professor of Medicine, Mayo Clinic, Jacksonville, FL.


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Peregrine Pharmaceuticals (NASDAQ: PPHM)
, a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM).

The FDA has agreed with the company's proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration and orphan drug designation by the European Medicines Agency.  Cotara is a targeted loco-regional therapy that delivers a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue. Cotara is being studied as a one-time treatment that in previous clinical trials has shown promising overall survival in patients with recurrent GBM.



Also Wednesday:



Align Technology, Inc. (NASDAQ: ALGN)
today announced the promotion of Christopher C. Puco to vice president, North American Sales, reporting to Align President and CEO Thomas M. Prescott.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at the Oppenheimer 23rd Annual Healthcare Conference on Wednesday December 12, 2012 at 3:55 pm Eastern Time.

Align Technology, Inc. (NASDAQ: ALGN)
today initiated a set of organizational changes to more effectively support business functions along its Clear Aligner and Scanner and CAD/CAM Services product lines.

Andain Inc. (OTCQB: ANDN)
("Andain" or the "Company"), a company engaged in commercializing novel technologies in biotech, medical and life sciences fields, today discussed its breakthrough miniature fully disposable and programmable insulin pump.

Array BioPharma Inc. (NasdaqGM: ARRY)
announced today the sale of 2,700,000 shares of its common stock pursuant to the exercise of the over-allotment option granted to the underwriters in connection with Array's previously announced underwritten public offering of 18,000,000 shares of its common stock at a public offering price of $3.65 per share.

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC)
today reported on interim results from a cooperative group sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer that were presented at the San Antonio Breast Cancer Symposium (SABCS) held from December 4-8, 2012.

CorTronix™ Biomedical Advancement Technologies, Inc. (OTCQB and Pinksheets: CBAT)
a BioMedical device developer and manufacturer of next generation Telemetric Medical Devices announced that it has engaged Maplehurst IR, a financial marketing and investor relations firm to assist the company in building and maintaining shareholder awareness.

Diagnostic Imaging International Corp. (OTCQB:DIIG) (PINKSHEETS:DIIG)
is pleased to announce that it has sold, through a private placement to accredited investors, three year 12% convertible notes ("Notes") in the aggregate principal amount of $1,865,000.

eHealth, Inc. (NASDAQ: EHTH)
, parent company of entities that operate PlanPrescriber.com and eHealthMedicare.com, published the six questions most commonly asked during Medicare's Annual Enrollment Period (AEP), by adults providing unpaid care (caregivers) for loved ones with Medicare.

Health Sciences Group, Inc. (PINKSHEETS: HESG)
today announced that it has entered the highly sought-after and lucrative healthcare mobile apps for the medical marijuana industry.

iSatori, Inc. (OTCQB: IFIT)
("iSatori" or "the Company"), an emerging leader in the development and marketing of scientifically engineered nutritional supplements for healthier lifestyles, announced today at the 5th Annual LD MICRO Micro-Cap Growth Conference, a significant initial stocking order for its Energize™ (www.isatori.com/energize) product from Walgreens, a Fortune 500 mass merchandiser and the largest drug retailing chain in the United States. Specific terms of the order were not disclosed.

La Jolla Pharmaceutical Company (OTCQB: LJPC)
("La Jolla" and "Company"), a leader in the development of therapeutics that target galectin-3, announced today that the FDA Division of Cardiovascular and Renal Products has approved the Company's Investigational New Drug Application ("IND") for GCS-100.

Lannett Company, Inc. (NYSE MKT: LCI)
today announced that the company will present at the Oppenheimer 23rd Annual Healthcare Conference on Wednesday, December 12, 2012 at 1:35 p.m. ET at the Waldorf Astoria Hotel in New York City.

Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, received official notification from European Patent Office (EPO) that the company has been issued a key patent covering monoclonal antibodies against sphingosine-1-phosphate (S1P), including sonepcizumab™.

Mauna Kea Technologies (NYSE Euronext: MKEA)
, leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that its UroFlex™ confocal miniprobe received CE mark approval for use during cystoscopy procedures.

PAREXEL International Corporation (NASDAQ: PRXL)
announced today that it will be presenting at the Oppenheimer Healthcare Conference in New York.

Premier Biomedical, Inc. (OTC-BB: BIEI)
today announced successful advances in its cancer-focused research.  Researchers successfully killed a cancer tumor in a test tube by simply removing crucial molecular compounds necessary for the cancer's development.

Pressure BioSciences, Inc. (OTCQB: PBIO)
("PBI" or the "Company") today announced that Mr. Conrad F. Mir has joined the Company as its chief financial officer ("CFO"), effective immediately.

Rite Aid Corporation (NYSE: RAD)
said today that it will release financial results for its Fiscal 2013 Third Quarter, which ended Dec. 1, 2012, on Thursday, Dec. 20, 2012.

RXi Pharmaceuticals Corporation (OTC: RXII)
, today announced that dosing with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids has been initiated.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company's business strategy and commercial and development-stage programs will be given at the Oppenheimer 23rd Annual Healthcare Conference being held at the Waldorf=Astoria in New York City.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health delivery system, today announced that it will be presenting at Oppenheimer's 23rdAnnual Healthcare Conference.

WPCS International Incorporated (NASDAQ: WPCS)
, a leader in design-build engineering services for communications infrastructure, has announced that it will issue its FY2013 second quarter financial results on Monday, December 17, 2012 after the market closes to be followed by a conference call scheduled for 5:00 pm ET.

XTL Biopharmaceuticals Ltd (TASE: XTL) (OTC: XTLBY)
(the "Company", or "XTL"), a biopharmaceutical development company that recently acquired the controlling stake of Proteologics Ltd (TASE: PRTL) announces that Mr. David Grossman, Chief Executive Officer of XTL and Mr. Efri Argaman, were appointed as members of the board of directors of Proteologics. Furthermore, the Board of Directors of Proteologics appointed Mr. Efri Argaman Chairman of the Board of Directors, with immediate effect.



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