Rexahn Initiates Dosing in Phase I Trial of Supinoxin; Cleveland BioLabs and Incuron Announce Start of US Trial With CBL0137 Print E-mail
By Staff and Wire Reports   
Wednesday, 07 August 2013 18:51
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 7, 2013.

Rexahn Pharmaceuticals, Inc. (NYSE: RNN)
a clinical stage biopharmaceutical company announced today the commencement of patient dosing with SupinoxinTM (RX-5902) in a Phase I clinical trial designed to study safety and efficacy in patients with solid cancer tumors.

Supinoxin is an orally administered, first-in-class, small molecule inhibitor of phosphorylated-p68 RNA helicase (P-p68). P-p68, which is selectively expressed in cancer cells and is absent in normal tissue, increases the activity of multiple cancer related genes including cyclin D1, c-jun and c-myc, and plays a role in tumor progression and metastasis. Over-expression of P-p68 has been observed in solid tumors, such as melanoma, colon, ovarian and lung.

The Supinoxin Phase I trial is a multi-center dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of Supinoxin and evaluating the preliminary anti-tumor effects of Supinoxin.

Dr. Joe J. Stephenson, MD, Medical Director, Institute for Translational Oncology Research (ITOR), Greenville Health Systems commented, “Supinoxin represents a very interesting new approach for the treatment of cancer patients with solid tumors. We are excited about investigating its potential as a novel therapy in cancer patients.”

Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer commented, “The start of Supinoxin dosing represents an important milestone for Rexahn. Supinoxin is Rexahn's third oncology compound to enter into clinical development and represents an important part of our expanding clinical development pipeline.”

In preclinical studies Supinoxin has been shown to inhibit proliferation of cancer cells in 18 human cancer cell lines including breast, colon, pancreas, ovarian, and stomach cancers, and showed potent activity in drug-resistant cancer cells. In an animal model, where human cancer cells from melanoma, pancreas, renal or ovarian cancers were grafted into animals, treatment with Supinoxin resulted in a significant reduction in tumor growth.

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Cleveland BioLabs, Inc. (Nasdaq: CBLI)
and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas is open for enrollment and that treatment of the first patient has been initiated.

The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum. FACT expression will also be tested on patient's tumor tissue retrospectively to determine if the tumor signal can help guide patient selection for future studies.

The Company recently announced the publication of studies describing FACT as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports. The published work concluded that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation. Further studies are underway to determine if this biomarker can serve as a companion diagnostic to screen patients for CBL0137 treatment.

Jean Viallet, M.D., Chief Development Officer at Cleveland BioLabs, commented, "We are excited to have a second study with CBL0137 underway. The role of FACT as an enhancer of oncogenic transcription supports the clinical potential for CBL0137."

 
Also Wednesday:

 
Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today reported financial results for the quarter and six months ended June 30, 2013.

Array BioPharma Inc. (NASDAQ: ARRY)
today reported results for the fourth quarter and full year of its fiscal year ended June 30, 2013.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today reported unaudited financial results for the second quarter and six months ended June 30, 2013.

Biomerica, Inc. (OTCBB: BMRA)
announced today that it has received approval to market and sell its H. Pylori and Parathyroid Hormone (PTH) diagnostic tests in Mexico.

Capstone Therapeutics (OTCQB:CAPS)
, will hold a conference call and webcast on Wednesday, August 14, 2013 at 4:30 pm EDT. The call may be accessed at 877-303-2908 (U.S.), 408-427-3860 (outside U.S.); accompanying slides may be viewed by logging onto the Investors section of the Company's website, www.capstonethx.com.

Cardium Therapeutics (NYSE MKT: CXM)
today announced that it has entered into a distribution agreement with Kasiak Holdings AG for the marketing and sale of Excellagen® advanced wound care product in Germany and Switzerland.

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 second quarter of 2013.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
today reported financial results for the quarter and six months ended June 30, 2013.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today reported recent business highlights and financial results for the second quarter and six months ended June 30, 2013, updating certain preliminary second quarter 2013 results issued on July 23, 2013.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that members of the Company's management team will deliver corporate presentations at the following investor conferences.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced the appointment of V. Bryan Lawlis, Jr., Ph.D. to the KaloBios Board of Directors.

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of post-acute care services, today announced its financial results for the three months and six months ended June 30, 2013.

Luminex Corporation (NASDAQ: LMNX)
today announced a restructuring plan focused on its Assay and Related Products ("ARP") Segment's Newborn Screening Group and its Brisbane, Australia office.

MELA Sciences, Inc. (Nasdaq:MELA)
, the medical device company that has developed and is commercializing MelaFind®, the first and only FDA approved optical diagnostic device for melanoma detection used by dermatologists in their fight against melanoma, today announced financial results for the second quarter ended June 30, 2013.

Nuvilex, Inc. (OTCQB: NVLX)
is methodically laying the foundation today for what should be a very busy and promising future tomorrow. After making a blockbuster deal to acquire Bio Blue Bird and its worldwide licenses associated with the live-cell encapsulation platform technology to develop treatments for all cancer types, Nuvilex announced this week that it now intends to do the same thing with diabetes.

Ohr Pharmaceutical Inc. (NasdaqCM: OHRP)
today announced the addition of John J. Wroblewski M.D. to its Scientific Advisory Board ("SAB"). The board, comprised of leading retinal ophthalmology experts, advises the company on its clinical programs, regulatory strategy and provides strategic guidance to support the ongoing development of lead drug candidate Squalamine in multiple neovascular ophthalmic clinical indications, each with sizable commercial markets.

OraSure Technologies, Inc. (Nasdaq:OSUR)
, a market leader in oral fluid diagnostics, today announced its consolidated financial results for the second quarter and six months ended June 30, 2013.

PAREXEL International Corporation (NASDAQ: PRXL) today reported financial results for the fourth quarter and Fiscal Year 2013, which ended on June 30, 2013.

PharmAthene, Inc. (NYSE MKT: PIP)
, a biodefense company developing medical countermeasures against biologicaland chemical threats, today reported its financial and operational results for the second quarter of 2013.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today provided development program updates and announced financial results for the second quarter ended June 30, 2013.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that the United States Patent and Trademark Office granted U.S. Patent No. 8,502,018 relating to methods of genetically modifying a mouse to make human antibodies.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic®development programs and an overview of the company's business strategy at 9:10 am ET on Wednesday, August 14, 2013, at the 2013 Wedbush Life Sciences Management Access Conference which will be held in New York City.

Shire plc (LSE: SHP, NASDAQ: SHPG)
has recently launched a new educational resource for people with diabetes and their caregivers as part of its HealTogether national awareness program.

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the second quarter ended June 30, 2013, and provided a business update.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced today that the Company's President and Chief Executive Officer, Dr. Mark J. Murray, will present at the 2013 Wedbush Life Sciences Management Access Conference on Wednesday, August 14, 2013 at 1:55 pm Eastern Time (10:55 am Pacific Time) at Le Parker Meridien in New York, NY.

Verenium Corporation (Nasdaq: VRNM)
, a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today reported operating highlights and financial results for the second quarter and six months ended June 30, 2013.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF)
, a leader in cancer detection technology, announced today it has entered into a collaboration with the BC Cancer Agency and Fujian Normal University in China (the "University") to develop a new application for the Company's exclusively licensed platform technology.

XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, today reported its operational highlights and financial results for the quarter ended June 30, 2013.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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