Depression Test

Groups pushing for share of future alcohol tax revenue Maryland makes a bio-splash at international convention Maryland companies stimulated by federal program Passage of same-sex marriage bill in New York won’

NSI-189, discovered by Neuralstem, stimulates new neuron growth in the hippocampus region in the brain, according to a company statement. The hippocampus is believed to be involved in depression and other diseases and conditions, such as Alzheimer's disease and post-traumatic stress disorder.

"The trial is proceeding as expected," Chairman and Chief Scientific Officer Karl Johe said in the statement. "There have been no adverse events to date. We are on schedule to complete phase 1a in July, and with approval from the [Food and Drug Administration], plan to begin phase 1b this fall."

Meanwhile, Rexahn Pharmaceuticals has finished enrolling patients in its phase 2b clinical study of Serdaxin to treat major depressive disorder.

The trial, involving 300 patients at about 40 sites in the U.S., started enrollment in January, according to a statement from the Rockville biotech. Rexahn expects to report initial data late this year.

"We are very excited by the speed at which we’ve completed enrollment in our Phase IIb trial for Serdaxin and believe that this further validates the current unmet need for an effective treatment for major depressive disorder,” COO and President Rick Soni said in the statement.

EntreMed, a Rockville biotech that’s developing an ovarian cancer treatment, has tapped $1.1 million of a new $7.5 million equity facility with YA Global Master SPV, a fund managed by Yorkville Advisors of Jersey City, N.J.

Under their agreement, YA Global is obliged to purchase up to $7.5 million of common stock in tranches at EntreMed’s discretion for the next three years. EntreMed paid Yorkville a one-time fee of $26,000 and issued YA Global 39,741 shares of common stock as a commitment fee, according to a company statement.

“This financing vehicle provides us with additional liquidity and the ability to move forward with our clinical development plans,” Michael M. Tarnow, the company’s executive chairman, said in the statement. “In the coming weeks we will have the final data from the current phase 2 trial and we are currently evaluating our strategies for the next clinical evaluation of ENMD-2076."

Data from a phase 3 clinical trial of MacroGenics’ candidate to treat type 1 diabetes indicate that it did not meet its primary endpoint, but showed promise for certain patients.

A report on the study, published in the British medical journal The Lancet, shows that teplizumab, a monoclonal antibody, when administered in a 14-day full-dose regimen, preserves C-peptide and increases the percentage of patients requiring very low doses of insulin.

"Although the Protege study missed its primary endpoint, the data appear to indicate that teplizumab has a desired biological effect in certain subpopulations with a potentially meaningful therapeutic benefit for patients with recent-onset type 1 diabetes,” Scott Koenig, CEO and president of the Rockville biotech, said in a statement. “These groups include patients for whom treatment is begun less than or equal to six weeks after diagnosis and in children 8 to 11 years old. In the coming months, MacroGenics will be exploring possible pathways forward for continued development of teplizumab."

The trial involves 513 patients, ages 8 to 35, that have been recently diagnosed with type 1 diabetes. They were treated at 83 clinical centers in North America, Europe, Israel and India. Rash was the most common adverse effect, compared with the placebo group.

Type 1 diabetes, an autoimmune disease, usually strikes in childhood, adolescence or young adulthood and lasts a lifetime. It is less common than type 2 diabetes; about 12 percent of the nearly 24 million diabetic Americans may have type 1, according to company information.

MedImmune of Gaithersburg won a $27.82 million contract from the Pentagon’s Defense Logistics Agency Troop Support in Philadelphia for its FluMist nasal influenza vaccine. The vaccines are for the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

A Gaithersburg biotech is working with a Chinese drug-maker to develop treatments for diabetic retinopathy and age-related macular degeneration.

Sirnaomics develops RNA interference therapeutics, which it uses with a nanoparticle-enhanced delivery technology, to develop treatments for scarless wound healing, ocular diseases, influenza infections and lung cancer.

The partnership with Guangdong Zhongsheng Pharmaceutical Co. is Sirnaomics’ second with a publicly traded Chinese pharmaceutical company, following an agreement six months ago with Guangzhou Xiangxue Pharmaceutical Co.

Guangdong Zhongsheng is committing $9.75 million to the deal, including upfront, milestone and royalty payments, according to a Sirnaomics statement.

"The partnerships with two public pharmaceutical companies in China mark a major milestone for Sirnaomics' endeavour on development and commercialization of siRNA therapeutics," CEO Patrick Y. Lu said in the statement. "While the Chinese pharmaceutical industry embraces our novel and innovative therapeutic programs, we receive financial support and expanded capacity as well to develop and commercialize our pharmaceutical products in China."

Mars Veterinary, along with the Fred Hutchinson Cancer Research Center and Argus Genetics, both of Seattle, in December sued BioPet Vet Lab and PetSafe, claiming the defendants infringed on their patent for dog DNA identification kits.

The latest chapter in the suit, which was filed in U.S. District Court in Norfolk, Va., unfolded last month. An appellate court on June 15 refused to lift the lower court’s injunction, issued in March, prohibiting BioPet and PetSafe from selling their ID kits, pending a resolution in the case.

Mars kits come in two versions: one that uses a mouth swab and one used by veterinarians that uses a blood test. The test, which can detail the breed composition of mutts, was developed by using analyses of more than 19 million DNA markers from more than 13,000 dogs, according to a Mars statement.

United Therapeutics of Silver Spring agreed to pay up to $49.9 million to DPR Construction of Redwood City, Calif., to manage a 180,000-square-foot expansion of its manufacturing and office facility in Research Triangle Park, N.C.

The expansion will help the company meet anticipated needs for additional warehouse, packaging and office space, according to a filing with the Securities and Exchange Commission. DPR managed construction of the company’s Research Triangle Park facility and is now managing another project for the United Therapeutics in Silver Spring.

Sanaria of Rockville, which is developing malaria vaccines, has launched a sales operation, selling parasites, mosquitoes and assay services to the general research community.

Besides infected mosquitoes, the company is offering other products developed in its regulated, good manufacturing practice facility, including monoclonal antibodies and reagents.

Emergent BioSolutions reported that the Singapore Health Sciences Authority OK’d its application to sell its anthrax vaccine there. BioThrax is the only anthrax vaccine licensed by the FDA.

"Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim," Daniel J. Abdun-Nabi, president and COO of the Rockville company, said in a statement. Following this approval, “we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize [Singapore-] registered products, such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon."

Glycotex said it has submitted to federal regulators final data from two phase 2 trials in which its gel product helped heal wounds in patients undergoing carbon dioxide laser skin resurfacing.

“Although this study was not statistically powered to determine efficacy of GLYC-101 gel, all wound sites, regardless of treatment, displayed complete wound closure without signs of delayed healing, and the median time to complete wound closure was 15 days for all ablated sites, regardless of treatment,” Glycotex said of one 12-patient study. “No serious adverse events have occurred in this study. Based on the results of this study, GLYC-101 gel, 1.0 percent was well tolerated in healthy subjects undergoing laser skin ablation and recommended for further clinical testing.”

Glycotex, an 81 percent-owned subsidiary of Novogen of Australia, is investigating the product to heal wounds after laser ablation, burn wounds, surgical wounds, venous ulcers and diabetic ulcers.

The global market for wound treatments grew 6.2 percent in 2010 and is expected to grow almost 7 percent this year, according to a new report titled “World Wound Care Markets 2011.”

PharmAthene reported achieving a technical milestone with the initial technology transfer of its manufacturing process for the bulk drug substance of its next-generation anthrax vaccine candidate, SparVax, at the 100-liter scale to a U.S. manufacturing facility at Diosynth RTP.

Activities to scale up production to the final commercial 1,500-liter scale have begun, according to a statement from the Annapolis biodefense company.

"As part of this transition, our process sciences team was able to optimize the production process for SparVax, increasing our bulk drug substance production yield approximately six-fold, further improving the cost effectiveness of our anthrax vaccine for the United States government,” Tom Fuerst, executive vice president and chief scientific officer, said in the statement. “We are currently moving forward to complete the implementation of the [good manufacturing practice] manufacturing processes and look forward to commencing additional clinical and non-clinical studies of SparVax in the coming months. Importantly, our achievement of this milestone will enable us to pursue additional advanced development funding."

Noxilizer of Baltimore is licensing its proprietary nitrogen dioxide technology to a Cary, N.C., company that will develop and commercialize it for the isolator generator market.

“This licensing agreement further validates Noxilizer’s technology and its importance in solving challenges of infection control and decontamination,” Lawrence Bruder, Noxilizer’s CEO and president, said in the statement. “The Noxilizer team is excited to work with STG as we grow our business in the important isolator market.”

“I see real advantages that the Noxilizer technology has over the current process options,” he said. “We believe customers will value the faster aeration time and improved material compatibility.”

The round was led by Safeguard Scientifics, with participation from existing investors including TPG Biotechnology II Fund and Quaker BioVentures.

NovaSom will use the investment to fund growth, expand its position in payer and provider markets, and develop more product innovations, according to a company statement.