Rexahn Announces Additional Data from Preclinical Studies of RX-3117; Genzyme and Isis Receive Corporate Award from the NORD Print E-mail
By Staff and Wire Reports   
Thursday, 08 May 2014 18:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 8, 2014.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced additional data from preclinical studies on the anti-tumor effects of RX-3117, a next generation cancer cell specific nucleoside analog. In the study, oral administration of RX-3117 inhibited tumor growth in 12 different human cancer xenograft models including colon, non-small cell lung, small cell lung, pancreatic, renal, ovarian, and cervical cancer. In addition, RX-3117 inhibited the growth of human cancer cells lines shown to be resistant to the anti-cancer effects of gemcitabine, including in the primary low-passage human pancreatic tumorgraft model.

“Resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients. Up to 25% of cancer patients receiving one or more cycles of gemcitabine rapidly become resistant to its anti-cancer activity. Based on study results to date, both preclinical and clinical, we believe RX-3117 holds the potential to be used for the treatment of tumors that do not respond to gemcitabine and other chemotherapeutic drugs,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.

RX-3117 showed greater efficacy (tumor growth inhibition) as compared to gemcitabine in four different xenograft animal models with gemcitabine resistant human cancer cell lines: colorectal cancer (Colo205), small cell lung cancer (H69), cervical cancer (CaSki) and pancreatic cancer (CTG-0298).

Additionally, in a mouse xenograft model using human colorectal cancer cells, those treated with RX-3117 showed significantly longer survival as compared to those receiving other treatments. Mice treated with RX-3117 showed 100% survival through day 95 after initial treatment, compared to 13% of mice treated with gemcitabine, and 25% of mice treated with irinotecan, both FDA-approved drugs.

Results of these studies were presented in a poster titled, “A novel small molecule cytidine analog, RX-3117, shows potent efficacy in xenograft models, even in tumors that are resistant to treatment with gemcitabine,” at the American Association for Cancer Research (AACR) Annual Meeting 2014 on April 6, 2014.

Earlier this year, Rexahn initiated a Phase Ib trial for RX-3117. The trial is a multi-center dose-escalation study which is evaluating the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumors. Secondary endpoints include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117.

In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe, to investigate the oral bioavailability, safety and tolerability of the compound. In this study, oral administration of RX-3117 demonstrated an oral bioavailability of 56% and a plasma half-life (T1/2) of 14 hours. In addition, RX-3117 was safe and well tolerated in all subjects throughout the dose range tested.



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Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), today announced that they have received the 2014 Partners in Progress Corporate Award from NORD in recognition of KYNAMRO® (mipomersen sodium) injection. KYNAMRO, selected for being a very important orphan therapy to reach the market in the United States, is an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

“There are over 7,000 rare diseases, of which, only 300 currently have a treatment option,” said NORD President and CEO Peter L. Saltonstall. “Each therapy brought to market for one rare disease provides hope to the many others that are still in need. We are pleased to recognize Genzyme and Isis for their dedication and commitment to improving the lives of patients with a rare disease.”

This award marks the third time that Genzyme has been recognized by NORD for its contributions and ongoing commitment to improving the lives of those affected by rare diseases. The award will be presented tonight at NORD’s "Portraits of Courage Celebration" in Washington, DC.

“It is an honor to be recognized by NORD and we hope this award serves to highlight the considerable unmet need that still exists in helping patients with rare diseases,” said Genzyme President and CEO, David Meeker, M.D. “We are proud that we are able to bring our rare disease expertise to patients living with HoFH, who have exhausted conventional medications and are still in need of additional treatment options.”

The NORD Gala is an annual event at which researchers and others are honored for improving the lives of people with rare diseases. Each year NORD honors organizations that have made a positive contribution to further the needs of the patient community, and have inspired the public to do so as well.

“KYNAMRO is the first systemic antisense drug to reach the market and is the culmination of two decades of work to create a new, more efficient drug technology platform,” said Stanley T. Crooke, M.D., Ph.D., Chairman of the Board and CEO of Isis. “We are incredibly grateful to NORD for its recognition of the work to bring this much needed therapy to patients living with HoFH.”

NORD is a nonprofit organization established in 1983 to represent all individuals and families affected by rare diseases. It provides advocacy, education, support for research, and patient assistance programs to improve the lives of the 30 million Americans living with rare diseases.



Also Thursday:



ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, announced today financial results for the third quarter of fiscal 2014 ended March 31, 2014.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, today announced that FDA has approved the protocol for the Company's planned Phase IIb clinical trial of MDX for the treatment of Fragile X Syndrome. The trial is expected to begin enrolling patients shortly.

Athersys, Inc. (Nasdaq:ATHX)
today announced its financial results for the three months ended March 31, 2014.

Baxano Surgical, Inc. (Nasdaq:BAXS)
, a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced its financial results for the first quarter ended March 31, 2014.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, announced today its financial results for the first quarter ended March 31, 2014.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR),
a premier provider of long-term care services primarily in the Southeast and Southwest, today announced its results for the first quarter ended March 31, 2014.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, today reported financial results for the quarter ended March 31, 2014, as well as recent highlights.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, assisted and independent living, home health, hospice care and urgent care companies, today reported operating results for the first quarter of 2014.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the first quarter that ended March 31, 2014.

GreeneStone Healthcare Corporation (OTCBB:GRST)
, a provider of healthcare services including Addiction and Mental Health has completed a transaction as part of a Strategic Financing announced on December 20, 2013 whereby GreeneStone had entered into a non-binding Letter of Intent ("Addiction LOI") to merge the assets of its addiction and mental health business with other addiction and mental health assets for a cash and equity consideration of up to $7.75 million.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 63 new employees.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today reported financial results for its first quarter 2014, and provided an update on recent accomplishments.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products announced its VENERATE™ Bioinsecticide has been submitted for registration in Canada and Mexico.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at the UBS Global Healthcare Conference being held May 19-21, 2014 at the Sheraton New York Hotel.

MRI Interventions, Inc. (OTCQB:MRIC)
, a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its financial results for the quarter ended March 31, 2014.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ)
announced that trading of K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, commenced on The NASDAQ Stock Market on May 8, 2014.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, today announced first quarter 2014 financial results as well as the closing of the Company's acquisition of California Stem Cell, Inc., an Irvine, California based biotechnology company.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announced today the release of the investigative report on the accident that took place November 8, 2012 at the Sherbrooke production plant.

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
announced today that the last enrolled patient has completed participation in the Company's pivotal Phase 3 clinical trial, NX02-0018.

Ocera Therapeutics, Inc. (Nasdaq:OCRX)
, a biopharmaceutical company focused on innovative therapeutics for orphan liver disease, announced today its financial results for the first quarter ended March 31, 2014.

Polypore International, Inc. (NYSE:PPO)
today announced that its Celgard subsidiary and Panasonic Automotive and Industrial Systems Division ("Panasonic") have entered into a long-term supply agreement under which Panasonic will purchase Celgard® brand separators to be used in its large-format electric drive vehicle lithium-ion batteries.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
today reported its consolidated financial results for the first quarter ended March 31, 2014.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced financial results for the first quarter ended March 31, 2014, and provided an update on the company's product development activities.



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