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Spherix — the formerly split-personality company that once handled reservation calls for national parks while pursuing biotech treatments for diabetes — this week announced positive clinical trial results, while also receiving a metric ton of the drug candidate from an Italian supplier and terminating its licensing agreement with a Danish company that used the product as a food sweetener.

The Bethesda company, which has shed its reservation-calls business, reported that a phase 2 clinical trial of Naturlose showed encouraging preliminary results in treating type 2 diabetes. The trial is to conclude early next year.

The compound, known generically as D-tagatose, showed promise in reducing levels of HbA1c when taken orally with meals three times daily. Naturlose is also in a phase 3 clinical trial, which is scheduled to conclude this year. If the trial yields positive results, the company plans to seek federal approval shortly thereafter.

"The results of this ongoing Phase 2 study are encouraging and reaffirm our belief that Naturlose may be a valuable treatment option for patients with Type 2 diabetes," said CEO Claire Kruger in a statement.

"Naturlose, administered at three separate low doses, proved to be effective for at least 6 months in reducing HbA1c, a key indicator of Type 2 diabetes that monitors glycated hemoglobin in the blood," Kruger said. "These data, combined with the fact that Naturlose is a naturally occurring compound with no known contraindications to current Type 2 diabetes treatments, continues to lead us to believe that there will likely be a place for Naturlose in the treatment regime as either a stand-alone or an adjunct therapy. In addition, the effect on serum lipoproteins may lead to a role for Naturlose in the treatment of atherosclerosis and the metabolic syndrome."

About 90 percent of the 23.6 million Americans with diabetes have type 2, with rates doubling from 1990 to 2005, according to the Centers for Disease Control and Prevention.

Spherix also said it has received its first full-scale production batch of D-tagatose that meets Food and Drug Administration standards from Inalco of Milan, Italy. The company Spherix plans to use the 1 metric ton shipment to help satisfy the chemistry, manufacturing and control requirements of its new drug application to the FDA. It will also be used in its phase 3 trial.

D-tagatose occurs naturally in small amounts in dairy products, is a highly soluble white crystal or powder, and is 92 percent as sweet as table sugar.

Also this week, Spherix said it terminated its 1996 licensing agreement with Arla Foods of Denmark, which used D-tagatose as a food and beverage sweetener.

"While we recognize the potential value that D-tagatose has as a food and beverage additive, we are currently focusing on the potentially more profitable uses of tagatose … as a novel pharmaceutical treatment for Type 2 diabetes," Kruger said.

The company expects preliminary results from this phase 3 study in the fall of 2009, and plans to file a new drug application with the FDA shortly after the conclusion of the phase 3 study if the results are positive.

In other Maryland bioscience news:

BioElectronics wants the FDA to approve over-the-counter marketing of its electronic patch for relieving menstrual cramps and pain.

The Frederick company said it filed for FDA clearance after a clinical trial in which 71 percent of women in the active group reported either complete elimination or a reduction in their typical menstrual pain symptoms, with 49 percent showing at least a 50 percent reduction in pain.

"While between 60 percent and 70 percent of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to significantly restrict daily activities, there are very few safe alternatives for pain relief," said CEO Andrew Whelan in a statement.

BioElectronics is pitching the wafer-thin patch as a drug-free alternative to acetaminophen. The company already sells an electronic-pulsing patch for reducing inflammation and healing surgical and other wounds.

RegeneRx of Bethesda received an Australian patent covering certain compositions and methods for delivery of Thymosin beta 4. The patent expires in 2024.

The compound, in phase 2 clinical trials, is a synthetic version of a naturally occurring peptide found in human cells. RegeneRx is developing several treatments based on Thymosin beta 4, including eye drops it is testing with the U.S. Army Medical Research Institute of Chemical Defense to prevent or reduce damage caused by exposure to chemical agents.

The state Maryland awarded 12 Nanobiotechnology Research and Industry Competition Grants totaling $3 million to the following:

-Aeras Global TB Vaccine Foundation of Rockville, $250,000 for delivery of tuberculosis vaccines.

-AparnaBio of Rockville, $250,000 for lung cancer treatments.

-Applied Sensor Research & Development Corp. of Arnold, $250,000 for infectious agent diagnosis.

-Bioactive Surgical of Baltimore, $250,000 for orthopedic therapies.

-CytImmune Sciences of Rockville, $250,000 for tumor treatment.

-Johns Hopkins University of Baltimore, $230,000 for cell therapy; and $250,000 for breast cancer treatment.

-University of Maryland, Baltimore, $250,000 for fluorescence sensing.

-University of Maryland, College Park, $200,000 for manipulation of DNA structures; $250,000 for nano-networks; $232,000 drug delivery nanocontainers; and $250,000 for a methanol fuel cell.

Innovative Biosensors of Rockville entered into a manufacturing and distribution agreement with Thermo Fisher Scientific of Waltham, Mass., under which Thermo Fisher will produce Innovative Biosensors' biological aerosol collection, detection and identification system.

The product is designed to detect up to 21 pathogens in single test or multi-test formats in three minutes. Thermo Fisher will also have a worldwide sales, marketing and distribution license under its Thermo Scientific brand in certain markets.

A significant amount of bioscience space has come on the leasing market in the I-270 Tech Corridor.

Human Genome Sciences wants to lease 175,000 square feet in its Rockville headquarters that was vacated by the previous tenant, MedImmune. The space, owned by BioMed Realty Trust of San Diego, comprises manufacturing, laboratory and office space.

Two years ago, MedImmune said it leasing the space to develop and manufacture clinical trial material for cell culture-based seasonal and pandemic influenza vaccines.

Scheer Partners of Rockville is marketing the space, along with 50,000 square feet of space available the J. Craig Venter Institute, also in Rockville. The institute, with about 200,000 square feet of space spread among five buildings, seeks to lease 50,000 square feet in three of the buildings.

Micromet of Bethesda, along with its partner Nycomed, has launched the first clinical trial of a human antibody that has shown promise for treating autoimmune and inflammatory diseases, including rheumatoid arthritis, multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease.

Micromet is primarily responsible for non-clinical development of MT203; Nycomed, of Zurich, Switzerland, is responsible for clinical development and commercialization.

Also, Micromet reported selling 655,868 shares of common stock for $2.75 million to Kingsbridge Capital.

The MdBio Division of the Tech Council of Maryland has announced its support for Gov. Martin O'Malley's industry initiative, BioMaryland 2020: A Strategic Plan for the Life Sciences Industry in Maryland.

The plan, developed by the Maryland Life Sciences Advisory Board, is a 17-point program whose "one-stop shop" centerpiece, the Maryland Biotechnology Center, was recently launched.

MdBio said it also supports other elements including increased funding for the state's biotech investment tax credit, more funding for the Maryland Venture Fund, expanding the state's research and development tax credit, supporting stem cell research and encouraging nanobiotechnology.

"It is our intention to work closely with the Maryland Biotechnology Center and the Maryland Life Sciences Advisory Board in a synergistic manner to advance implementation of these recommendations for the good of our member companies and for the life sciences industry in Maryland as a whole," said Richard A. Zakour, MdBio executive director, in a statement.

Osiris Therapeutics of Columbia reported mixed results from interim data in a phase 2 clinical trial evaluating its stem cell treatment Prochymal in treating chronic obstructive pulmonary disease.

The two-year trial on 62 patients has been under way for six months. The study has met its primary goal of demonstrating safety, Osiris reported. Also, the treatment has "significantly decreased systemic inflammation in patients when compared to those receiving placebo, as determined by C-reactive protein," it said.

However, "despite the reduction in inflammation, pulmonary function in patients receiving Prochymal was not significantly improved compared to those receiving placebo."

"We are very pleased with the interim outcome of this study and that the data continues to support the strong safety profile of this therapy, particularly given the severity of these patients' pulmonary disease," said president and CEO C. Randal Mills in a statement. "Importantly, we are gratified to obtain clear, objective data that helps bolster our understanding of the anti-inflammatory effects of these remarkable cells. Short-term, these anti-inflammatory effects did not appear to improve pulmonary function in patients with advanced destructive changes of the lung. Collectively however, these findings add to our confidence about the safety and effectiveness of the drug."

Osiris has a development and commercialization agreement for Prochymal with Genzyme.

Several Maryland research centers are receiving grants from the National Institutes of Health in Bethesda to expand the agency's Human Microbiome Project.

The five-year, $140 million project is studying how the human microbiome — the microscopic organisms that live in or on the human body, plus their genomes — affect health.

The project is focusing on the digestive tract, mouth, skin, nose, vagina, blood and male urethra.

The J. Craig Venter Institute in Rockville and researcher Robert L. Strausberg won $8.8 million over four years, with funding through the 2009 American Recovery and Reinvestment Act.

Also, Claire M. Fraser-Liggett, director of the Institute of Genome Sciences at the University of Maryland School of Medicine in Baltimore, won two $1 million grants to study the microbiome and the digestive tract, specifically looking at obesity and Crohn's disease. Jacques Ravel of the medical school won $980,000 to study bacterial vaginosis.

Also, Julia Segre of the National Human Genome Research Institute in Bethesda won $400,000 to study atopic dermatitis, an inflammatory skin disease.

Medifacts International of Rockville has acquired the Clinical Trials Services division of Spacelabs Healthcare of Issaquah, Wash. Terms were not disclosed.

Medifacts is a cardiovascular core lab, while Clinical Trials Services provides cardiovascular safety and diagnostic services to the pharmaceutical and biotechnology industries.

Fast-Track Drugs & Biologics of North Potomac signed a research and development agreement with Atox Bio of Jerusalem, Israel, to develop treatments for sepsis and septic shock.

The collaboration includes pre-clinical studies and a phase 1 clinical trial to be performed at the University of Maryland, Baltimore. The program has received $575,000 from the Israel-U.S. Binational Industrial Research and Development Fund.