Ligand Announces Preclinical Data for Glucagon Program; CytRx Reaches Enrollment Target in International Phase 2b Clinical Trial with Aldoxorubicin Print E-mail
By Staff and Wire Reports   
Monday, 24 June 2013 18:51

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 24, 2013. Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced the presentation of a poster titled “Glucagon Receptor Antagonist LGD-6972 Is Efficacious in Streptozotocin-Induced Diabetic Mice” at the 73rd Scientific Sessions of the American Diabetes Association in Chicago. The poster provides data from preclinical studies of Ligand's novel compound, LGD-6972, demonstrating significant glucose lowering activity in an animal model of type 1 diabetes.

Highlights of the presentation include:  * LGD-6972 is a potent and selective antagonist of the glucagon receptor (GCGR) that has previously demonstrated activity in pre-clinical models of type 2 diabetes. * LGD-6972 significantly lowered fasting and non-fasting glucose levels in a mouse model of type 1 diabetes. * LGD-6972 reduced HbA1c, ketone bodies, and free fatty acids in diabetic mice. * LGD-6972 had additive effects when used in combination with insulin therapy and may be useful in an insulin sparing regimen.

“Glucagon receptor antagonism could play an important role in the treatment of diabetes. Previous studies have demonstrated efficacy in models of type 2 diabetes and the present work shows utility for type 1 diabetes as well,” commented Matthew W. Foehr, Executive Vice President and Chief Operating Officer of Ligand. “Our glucagon program is an important example of the diversity of partnered and unpartnered products making up Ligand's extensive portfolio of assets. We plan to submit an IND for LGD-6972 in the second half of 2013.”


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CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, announced that it has reached the targeted enrollment of 105 evaluable patients in its international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma. This trial allows for a head-to-head clinical comparison of the efficacy and safety of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's improved version of doxorubicin.

“Achieving this key milestone puts us on track to report highly anticipated progression-free survival data from the Phase 2b clinical trial in the second half of 2013,” said Steven A. Kriegsman, CytRx President and CEO. “Doxorubicin is a well-known chemotherapy drug, having been used by the medical community for decades, and it is the current standard of care for advanced, metastatic soft tissue sarcoma as well as numerous other cancers. Doxorubicin, however, has many side effects, including potential damage to the heart muscle. These side effects limit the dosage of doxorubicin to a level below its maximum anti-tumor capabilities.

“Aldoxorubicin is formulated using a novel linker technology designed to safely deliver higher concentrations of doxorubicin directly to tumors, which could improve effectiveness while reducing toxicity. In fact, the Phase 2b clinical trial is comparing a dose of aldoxorubicin that delivers doxorubicin at 3.5 times the dose of doxorubicin in the comparator arm of the trial,” he added. “Last month, the independent Data Safety Monitoring Committee overseeing the Phase 2b trial recommended conducting the trial to completion, indicating that the Committee had found no significant safety issues with aldoxorubicin, even at this high dose.”

In the Phase 2b clinical trial, patients with metastatic locally advanced or unresectable soft tissue sarcoma who have not been previously treated with any chemotherapy are randomized into two groups with twice as many receiving aldoxorubicin as doxorubicin. In addition to the primary objective of measuring median progression-free survival, the Phase 2b trial will evaluate tumor response and overall patient survival. The trial is being conducted at clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.

CytRx expects to evaluate aldoxorubicin in additional indications, and the linker molecule has broad utility with the ability to attach to multiple widely used chemotherapeutic agents. One or more of these agents may be incorporated in CytRx's future development plans. CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option rights to the linker platform technology.



Also Monday:



Advaxis, Inc., (OTCQB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated anal cancer. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), today announced that the United States Patent and Trademark Office will issue the Company's U.S. Patent #8,476,304, which includes claims covering modified release Metadoxine, the Company's lead drug candidate, on July 2, 2013.

American CryoStem Corporation (OTCQB:CRYO)
, a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced that Dayong Gao, Ph.D. has been appointed to the Company's Medical and Scientific Advisory Board.

Biogen Idec (NASDAQ: BIIB)
will showcase new data from a number of development and early-stage research programs at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress.

BioLife Solutions, Inc. (OTC:BLFS)
, a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced that it has been named by Seattle Business Magazine as one of the best places to work in Washington state.

BioTech Medics, Inc., (PINKSHEETS: BMCS)
announces it is planning BioTech Laser Center Walk-In Kiosks that can be located in malls and convention centers throughout the USA.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, today announced that its Sonicision™ cordless ultrasonic dissection system won the 2013 Medical Design Excellence Award (MDEA), one of the medical technology industry’s highest honors.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, announced that it has reached the targeted enrollment of 105 evaluable patients in its international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country's first commercially available transcatheter aortic heart valve.

iBio, Inc. (NYSE MKT: IBIO)
today released the following information, which was contained in the Portuguese language report published on June 18, 2013 in the official Journal of the Government of Brazil under the heading, "Brazil Expands Production of Biological Medicines."

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
today announced Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with advanced hematologic malignancies, or potentially fatal blood cancers.

Intercept Pharmaceuticals, Inc.  (NASDAQ: ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced the completion of its previously announced underwritten public offering of 1,730,000 shares of its common stock at a public offering price of $33.01 per share.

Kamada Ltd. (Nasdaq and TASE: KMDA)
today announced that the Company was granted two key patents related to its novel Alpha-1 Antitrypsin (AAT) product to treat respiratory diseases. Kamada was granted Russian Patent No. 2472524, entitled “Alpha-1 Antitrypsin for treating exacerbation episodes of pulmonary diseases,” and an additional Australian Patent No. 2007213344 (co-owned with PARI PHARMA GMBH), entitled “Pulmonary delivery of Alpha-1 proteinase inhibitor.”

LabStyle Innovations Corp. (OTCQB: DRIO)
, developer of the Dario™ smartphone-based glucose monitor and diabetes data-management system, announces that Harmonium Pharma has been named as the exclusive distributor for Dario in Italy.

La Jolla Pharmaceutical Company (OTCQB: LJPC)
, a leader in the development of therapeutics targeting galectin proteins, announced today that a recent online publication of the Journal of the American Society of Nephrology ("JASN") on June 13, 2013, by Conall M. O'Seaghdha and colleagues at the National Heart, Lung, and Blood Institute of the National Institute of Health ("NIH") independently confirms data La Jolla released on May 29, 2013.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced the presentation of a poster titled “Glucagon Receptor Antagonist LGD-6972 Is Efficacious in Streptozotocin-Induced Diabetic Mice” at the 73rd Scientific Sessions of the American Diabetes Association in Chicago.

Medidata Solutions (NASDAQ: MDSO)
introduced the Medidata Clinical Cloud™ Study, which brings the industry-leading benefits of Medidata’s cloud-based platform to single studies as an easy-to-acquire, ready-in-weeks option.

MMRGlobal, Inc. (OTCQB: MMRF)
today announced that MMRGlobal CEO Robert H. Lorsch concluded a six day East Coast trip focused on sales and licensing of the Company's patented health information technology products and services on the heels of an article discussing how legislation and Stage 2 Meaningful Use is kicking PHR usage into high gear and the value of health information technology patents.

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that it has signed an agreement with TESARO, Inc. (Nasdaq:TSRO) to conduct BRCA1 and BRCA2 mutation testing on patients to be enrolled in two separate Phase III clinical studies with niraparib.

Nuvilex, Inc. (OTCQB: NVLX)
has a great opportunity to demonstrate and showcase its encapsulation technology in its upcoming Phase III clinical trials for the treatment of late stage, inoperable pancreatic cancer.

Puma Biotechnology, Inc. (NYSE: PBYI)
, a development stage biopharmaceutical company, is set to join the broad-market Russell 3000® Index following Russell Investments’ annual reconstitution of its comprehensive set of U.S. and global equity indexes on June 28, according to a preliminary list of additions posted on June 14.

Quest Diagnostics (NYSE: DGX)
, the world's leading provider of diagnostic information services, announced today that it has completed the previously announced acquisition of lab-related clinical outreach service operations of Dignity Health, a hospital system based in California.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
today announced results from its dose-escalating, double-blind, placebo-controlled Phase 2 clinical trial in 30 patients with dystrophic and junctional epidermolysis bullosa (EB), a severe “orphan” skin disorder with limited prevalence in the U.S. and Europe.

Simulations Plus, Inc. (Nasdaq:SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced today that it has signed a Material Transfer Agreement (MTA) with the Division of the National Toxicology Program (DNTP) of the U.S. National Institute of Environmental Health Sciences (NIEHS) to provide licenses for its GastroPlus™, ADMET Predictor™, and MedChem Studio™ software programs for use by the DNTP/NIEHS.

Sorrento Therapeutics, Inc. (OTCQB: SRNE)
announced today that preclinical data of its therapeutic fully human anti-PD-L1 and anti-PD-1 monoclonal antibodies (mAbs) will be presented at the IBC 8th Annual Next Generation Protein Therapeutics Summit, June 26- 28 in San Diego.

SpectraScience, Inc. (OTCQB: SCIE)
announced today that PENTAX Medical GmbH, the sales, marketing and distribution partner for the WavSTAT4 Optical Biopsy System in Europe, has finalized and signed the minimum purchase requirement Exhibit of the Distribution Agreement for their fiscal year ending March 2014.

St. Jude Medical, Inc. (NYSE:STJ)
, a global medical device company, today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D).

Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF)
announces that it has completed a first closing of the second of its two previously announced non-brokered private placements and is providing a corporate update.




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