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For the second time in a month, a Maryland bioscience company has filed for bankruptcy.

But unlike Cyto Pulse Sciences of Glen Burnie, which filed for Chapter 7 liquidation, Correlogic of Germantown has filed for Chapter 11 protection and plans to soldier on with its cancer test candidate.

The company, which develops software for blood assays that look at multiple biomarkers for cancer, recently won approval from European regulators for its OvaCheck early detection test for ovarian cancer. Executives are negotiating deals with European labs to use the test.

But domestically, the Food and Drug Administration has "moved the goal posts" on Correlogic, says CEO and co-founder Peter J. Levine. A year ago the FDA ordered more studies before approving the test for use in the U.S.

"The FDA issue was not about results of the trial — there were no questions about that — but an arcane issue of the clinical trial population," Levine said in an interview. "There was no question about the fact that it worked."

Correlogic now is conducting a "second arm" of the trial on a slightly different population to address the FDA's concerns.

"We're in the middle of that," Levine said. "Assuming we get funding, we're probably about six to eight months from resubmitting to the FDA. We thought we'd be to market a year ago."

The company has struggled for years with the FDA, partly over whether OvaCheck should be defined as a medical device, which would put it under the agency's purview.

"We're in the Valley of Death — that's what [the National Institutes of Health] calls it," he said. "We have a product, we've spent tens of millions of dollars, we've proven it, but we're in a regulatory tug of war. The FDA has been moving the goal posts. It can't make up its mind. I don't question their good faith, but when the agency twitches, it has ramifications for industry and ultimately the public."

The FDA's rejection last year forced the privately held company to tighten its budget. It cut its staff from 18 to 10 full-timers and two part-timers and moved from Rockville to the business incubator on Montgomery College's campus in Germantown.

It also decided to file for Chapter 11 bankruptcy protection last week.

The company lists assets and liabilities of $1 million to $10 million. Most of its debt is back pay totaling $1.1 million owed to its employees, including $414,663 to Levine himself.

That so many Correlogic employees have worked without pay is a "testimonial to the loyalty and professionalism of the staff," Levine said. "We've had very rough times over the last year, but the staff hung in there."

The Chapter 11 filing also allowed Correlogic to get out of two contracts that were hamstringing its research and development efforts, Levine said. One of the contracts was with one of the company's investors, Quest Diagnostics of Teterboro, N.J., which owns 2.89 million shares of B preferred stock, according to Correlogic's website.

On Monday, the bankruptcy court granted Correlogic's motion to reject those contracts.

"That was a strategic move," Levine said. "It gives us more flexibility in how our product goes to market. It makes it more likely to have other investors come in and opens a wider range of how you ultimately finance this last leg of the long journey to get to market."

In other Maryland bioscience industry news:

Human Genome Sciences, anticipating demand for its lupus treatment candidate, has signed a manufacturing deal with Lonza of Basel, Switzerland.

The Rockville biotech has applied to the FDA for a license to market Benlysta, which it is developing with GlaxoSmithKline. GSK has applied for European approval for the treatment.

"Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of Benlysta following approval, and for the first two or three years following launch," said Randy J. Maddux, the company's vice president of manufacturing operations, in a statement. "However, we believe that we will eventually require additional capacity."

Benlysta would be the first new drug approved to treat lupus in more than 50 years.

Supernus Pharmaceuticals of Rockville reported launching a phase 2a clinical trial of its candidate to treat attention deficit hyperactivity disorder in adults.

The trial is to be conducted at five sites in the U.S. on up to 50 adults ages 18 to 64 who have ADHD. The primary goal is to measure safety and tolerability, followed by the ability to reduce ADHD symptoms.

"Nearly 10 million American adults are estimated to suffer from ADHD, and about 30 percent of patients do not adequately respond to or cannot tolerate stimulant ADHD treatments," CEO Jack Khattar said in a statement. "The mechanism of action of SPN812 appears to be promising as a novel treatment of ADHD and we believe it represents a strong alternative to existing ADHD regimens in the United States."

Supernus is developing three products to treat people with ADHD. It has completed a phase 2a trial of one candidate to treat children who exhibit persistent serious conduct problems and expects to initiate a phase 2 trial of the third candidate next year.

Columbia stem cell company Osiris Therapeutics got a boost from Canada this week, when regulators there accepted for review the company's application for Prochymal, an adult stem cell therapy for treating graft vs. host disease.

Health Canada also told Osiris the application will be expedited, shortening the examination period from 300 to 180 days.

If successful, Prochymal would become the world's first approved stem cell therapy, according to an Osiris statement.

The expedited review is granted when summary clinical data demonstrate "substantial evidence of the drug's effectiveness in treating a life-threatening condition," according to Osiris.

The application is Osiris' first in its global registration strategy for Prochymal, which now is available to patients with refractory acute graft vs. host disease in the U.S. under an expanded access program.

The Canadian registration also confers eight years of market exclusivity from when Prochymal is approved.

Nabi Biopharmaceuticals has finished enrolling patients in a phase 3 clinical trial of its vaccine designed to help people quit smoking and stay smoke-free.

Final data from the NicVax study are expected in the fourth quarter of 2011. A second phase 3 trial began in March; final results from that study are due in early 2012. Each study involves about 1,000 patients; the primary endpoint of each study is long-term abstinence from smoking at 12 months.

In March, Nabi closed a development and commercialization deal for NicVax with GlaxoSmithKline Biologicals, potentially worth more than $500 million to the Rockville company. The deal included a nonrefundable $40 million upfront payment, plus potential royalties.

"NicVax has the potential to shift the smoking-cessation therapeutic paradigm from quitting to long-term abstinence," CEO Raafat Fahim said in a statement. "... We believe that we have undertaken all the necessary steps to maximize the likelihood of success in phase 3. NicVax is on track to be the first-in-class nicotine vaccine for smoking cessation. No other competitors have reached this stage of development."

BioServe of Beltsville, which helps researchers gather preclinical data, has partnered with Windber (Pa.) Research Institute to share biosamples from Windber's tissue bank with BioServe's Global BioRepository. Windber's tissue bank includes many cancer specimens, plus healthy tissues.

"By offering these samples through BioServe's distribution channels, [Windber Research] will now be able to aid a much larger community of biomedical researchers," said Rama Modali, president of BioServe, in a statement.

BioServe's partners in its biospecimen networking include Fox Chase Cancer Center, The Fairbanks Institute and the University of Massachusetts Medical School.

GlycoMimetics of Gaithersburg has been granted two U.S. patents for its lead drug candidate and related compounds.

The patents cover GMI-1070, the biotech's candidate that is in clinical trials of patients with vaso-occlusive crisis of sickle cell disease, plus related molecules.

"Together these patents provide important intellectual property protection for GlycoMimetics' lead program," CEO Rachel King said in a statement. "The issuance of these patents also confirms that mimics of naturally occurring carbohydrates, which are the basis of the Company's technology, represent new and inventive chemical structures."

GMI-1070, which has been granted fast track and orphan drug status by the FDA, is in a phase 2 clinical test.

Vaso-occlusive crisis, which is sometimes fatal, typically requires hospitalization for up to six days, according to GlycoMimetics, with more than 75,000 such hospitalizations annually in the U.S.

PharmAthene of Annapolis, which is developing a next-generation anthrax vaccine, plans to sell $3.9 million of common stock and warrants to an existing institutional investor.

The company needs the cash because a bid protest lodged in March by a competitor, Emergent BioSolutions of Rockville, resulted in the federal government issuing a stop-work order to PharmAthene, according to a filing with the Securities and Exchange Commission. The protest was rejected in June, but the accumulated billing and collection delays cut into the company's cash flows.

The company expects the deal to close near the end of this week.

PharmAthene also reported results from a New Zealand white rabbit study showing its lyophilized, or freeze-dried, anthrax vaccine was more immunogenic than a liquid formulation and produced a robust response with only two doses. The study was funded by the National Institute of Allergy and Infectious Diseases.

"We're very encouraged by this preliminary study," said Valerie Riddle, senior vice president and medical director, in a statement. "The initial non-clinical animal data suggest that a lyophilized [recombinant protective antigen] vaccine formulation may be able to provide protection against anthrax infection with fewer doses than a liquid vaccine formulation. We will be conducting additional studies to confirm these preliminary results. In addition, a lyophilized formulation could yield important practical advantages in the field."

Previously this month, PharmAthene reported the freeze-dried vaccine can be stable in temperatures up to 158 degrees.

Meanwhile, Emergent revised upward its annual guidance for 2010, with anticipated revenues of $275 million to $300 million and profits of $40 million to $50 million, according to its SEC filing.

The revision follows the recent modification to the company's BioThrax contract with the Centers for Disease Control and Prevention, increasing the number of doses of its anthrax vaccine that Emergent can deliver to the Strategic National Stockpile this year.

Thymosin beta 4, a compound being developed by RegeneRx Biopharmaceuticals, improved neurologic function when given to rats after embolic stroke, the Rockville company said in a statement.

The research was conducted at Henry Ford Hospital in Detroit and was published in the August issue of Neuroscience.

The improvement was measured at various time intervals over seven weeks and was statistically significant, the company said.

Thymosin beta 4 is a synthetic version of a naturally occurring peptide present in most human cells. RegeneRx is researching its use in treating a variety of conditions, including cardiovascular and central nervous system diseases.

EntreMed of Rockville has regained listing compliance with the Nasdaq exchange after effecting a one-for-11 reverse stock split.

By maintaining a minimum closing bid of $1 for 10 consecutive trading days, EntreMed met the exchange's requirement on July 15.

"Maintaining a listing on the Nasdaq Capital Market is an important part of our corporate strategy," said Michael M. Tarnow, executive chairman, in a statement.

EntreMed has received orphan drug designation from the Food and Drug Administration for ENMD-2076 to treat ovarian cancer, multiple myeloma and acute myeloid leukemia. The company has completed a phase 1 study in patients with solid tumors and is conducting a phase 2 study in ovarian cancer and phase 1 studies in multiple myeloma and leukemia.

Seegene has introduced a new test, Magicplex Sepsis, which it says can quickly and accurately identify more than 90 sepsis-causing pathogens. The Rockville company is awaiting federal regulatory clearance.

Sepsis is the leading cause of death in non-coronary intensive care units around the world, according to a statement from the Rockville company. The annual incidence rate of sepsis has risen 91.3 percent in the past 10 years, and every hour 25 people in the U.S. die from it. One-third of patients with severe sepsis will die within a month.

"The Magicplex Sepsis Test will be the new gold standard for performing accurate, rapid and cost-effective sepsis diagnosis," said CEO Jong-Yoon Chun in the statement. "In treating sepsis, time and accuracy are demanded. Every hour of delay in giving patients the correct antibiotics results in an 8 percent increase in the mortality rate."

Precision Antibody of Columbia was selected by SAIC-Frederick to provide antibody and antigen characterization for the National Cancer Institute's Clinical Proteomic Technologies for Cancer initiative.

The program is trying to develop a standardized resource of high-quality, renewable reference antibodies generated against cancer-related proteins, according to a Precision Antibody statement. The antibodies are to be made available to proteomics researchers for replication and standardization.

Precision Antibody previously had won a contract with SAIC-Frederick to develop custom monoclonal antibodies for the NCI program.

"Our goal is to help the [NCI program] characterize antibodies and ultimately select the best antibodies that will minimize proteomic experimental variability from run to run, instrument to instrument, and lab to lab," said Jun Hayashi, vice president of Precision Antibody, in the statement.

Biosurface Engineering Technologies of Rockville, along with Brookhaven Science Associates, which manages the Department of Energy's Brookhaven National Laboratory, received a U.S. patent for an improved second-generation technology for designing synthetic peptides important for tissue regeneration.

The peptides are designed to communicate growth signals to cells of damaged tissue to promote more efficient, rapid healing, according to a statement from the laboratory.

The Rockville company, known as BioSET, has an exclusive license to produce these peptides, which were developed at the lab.

"This newly patented technology builds upon our core method for making synthetic biomimedic peptides that we developed with Brookhaven Lab scientists almost a decade ago," Tom Roueche, BioSET's president, said in a statement. "We can now make peptides in higher yields, with more purity, and more cost-effectively than we had done previously."

BioSET has sublicensed the technology to Tornier, a global orthopedic company in Edina, Minn., to develop synthetic peptides for sports medicine, especially rotator cuff, shoulder, knee and elbow injuries, according to the statement.

Correlogic Systems of Germantown

Founded: 2000.

Privately held.

Peter J. Levine: president, CEO, co-founder and largest shareholder with 6.5 million shares.

Focus: Early identification of cancer through blood tests for biomarkers.