CytRx Announces Agreement with FDA Soft Tissue Sarcoma; FDA Approves Second Drug in BD Simplist™ Print E-mail
By Staff and Wire Reports   
Tuesday, 23 April 2013 19:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2013.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. The Company is actively making preparations for the pivotal Phase 3 trial.

“By reaching an agreement on an SPA, the FDA deems that results from this single Phase 3 clinical trial will be acceptable to support the regulatory approval of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma, with final marketing approval dependent on the results of the trial and other accomplishments,” said Steven A. Kriegsman, CytRx President and CEO. “The ability to conduct the clinical trial under an SPA could save significant time compared with a standard regulatory pathway. Our optimism about aldoxorubicin's prospects in this difficult-to-treat indication is predicated on positive results from a Phase 1b/2 trial in which this novel agent was associated with objective responses and prolonged progression-free survival in several patients with advanced soft tissue sarcoma who had relapsed or not responded to prior treatments, as well as on additional clinical and preclinical data.”

The international, open-label pivotal Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to or have progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapies. Trial patients will be randomized 1:1 to be treated with aldoxorubicin or the investigator's choice of an approved chemotherapeutic regimen to include dacarbazine, pazopanib (Votrient®), gemcitabine plus docetaxel, doxorubicin or ifosfamide, with up to three comparator regimens to be selected by the investigator at each clinical site. The clinical trial will be conducted at approximately 80 clinical sites in the U.S., Europe, China, Canada, Latin America and Australia. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival and safety.

“There is a critical need for a second-line treatment for patients with soft tissue sarcomas that improves clinical benefit with fewer side effects,” said Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical Officer. “Multiple chemotherapy regimens have been explored as palliative therapy for these patients with several failures in Phase 3 trials. Additionally, currently approved chemotherapeutic regimens are frequently quite toxic with no significant impact on either progression-free survival or overall survival.”

In the Phase 1b/2 clinical trial in patients with advanced soft tissue sarcoma treated with aldoxorubicin in up to eight cycles at the maximum tolerated dose, 77% (10 of 13) of the evaluable patients showed clinical benefit, defined as partial response with tumor shrinkage in excess of 30% or stable disease at four months following treatment. None of the patients in the Phase 1b/2 trial showed cardiotoxicity and there were no drug-related patient deaths. Patients in this trial showed progression-free survival of approximately 6.4 months, with a range of 1.0 months to more than 10.7 months. This compares favorably with the median estimated progression-free survival for advanced soft tissue sarcoma patients of approximately 3 months.



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BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX), announced the U.S. FDA has approved the second drug to be offered in the recently launched BD Simplist™  line of ready-to-administer prefilled generic injectables. The second BD Simplist product to launch is Metoclopramide Injection, USP, an injectable antiemetic.

BD Rx launched its first drug – BD Simplist™ Diphenhydramine Hydrochloride Injection, USP, an injectable antihistamine – on March 27, 2013. BD Simplist prefilled injectables are designed to help improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence, reducing the potential risk of medication error.


Also Tuesday:


Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, today announced treatment of the first patient in the third dosage cohort, and seventh patient overall, in its European Phase I clinical trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") newly appointed President and CEO, David A. Dodd will hold an introductory analyst and investor conference call on Thursday, April 25, 2013 at 4:30 p.m., Eastern Time.

Amgen (NASDAQ: AMG
N) today announced financial results for the first quarter of 2013.  

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
(the "Company") announced that, on April 17, 2013, it received notice from the NYSE MKT LLC (the "Exchange") that it is not in compliance with certain of the Exchange's continued listing standards as set forth in Sections 134 and 1101 of the Exchange's Company Guide (the "Company Guide") as a result of the failure to file its annual report on Form 10-K on a timely basis.

DIA Nutrition, Inc. (PINKSHEETS: ADIA) is proud to announce the launch of its new website: www.adianutrition.com.

Digirad Corporation (NASDAQ: DRAD) announced today that Institutional Shareholder Services Inc. ("ISS") and Glass Lewis & Co. ("Glass Lewis"), two leading independent proxy advisory firms, have recommended that stockholders vote for all five of Digirad's nominees -- Jeffrey E. Eberwein, John M. Climaco, Charles M. Gillman, James B. Hawkins, and John W. Sayward -- and all other company proposals, on the WHITE proxy card at Digirad's 2013 Annual Meeting of Stockholders to be held on May 3, 2013.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended March 31, 2013, of $144.9 million compared to net income for the same period last year of $65.1 million.

iBio, Inc. (NYSE MKT: IBIO)
announced today the pricing of an underwritten public offering of 8,925,000 units at $0.48 per unit for gross proceeds of approximately $4,280,000.

InspireMD, Inc. (NYSE MKT: NSPR)
("Inspire" or the "Company"), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA).

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the first quarter of 2013 on May 6, 2013 after the close of the financial markets.

Lannett Company, Inc. (NYSE MKT: LCI)
today announced that the company will present at the Needham’s 12th Annual Healthcare Conference on Wednesday, May 1, 2013, at 2:20 p.m. ET at The Westin Grand Central Hotel, 212 East 42nd Street, New York.

LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (NYSE MKT:BTX), announced today a collaborative partnership and value-added reseller agreement with Appistry, Inc., which provides big-data computing that supports life-science and medical analytics at hospitals and medical research centers and organizations.

Life Technologies Corporation (NASDAQ: LIFE) today announces that it is a lead commercial partner along with Aridhia, a bio-medical informatics company, in the Stratified Medicine Scotland Innovation Centre (SMS-IC).

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand, is scheduled to present at the following upcoming investor conferences:  12th Annual Needham Healthcare Conference in New York, NY. Presentation: Tuesday, April 30, 2013 at 8:00 a.m. Eastern (5:00 a.m. Pacific).

Medivation, Inc. (NASDAQ: MDVN) today announced that Dawn Graham has been elected to the Company's Board of Directors.

mPhase Technologies, Inc. (OTCBB: XDSL)
reported today that it has commenced the discussion of its drug delivery system with a major European Drug Company.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today financial results for the first quarter ended March 31, 2013.



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