Stem cell biotech Osiris Therapeutics wins overseas -- Gazette.Net


Osiris Therapeutics announced a couple of legal and regulatory victories this week.

The Columbia biotech, which develops stem cell treatments for a variety of conditions, won a challenge to its Australian patent.

The patent, filed in 2009, covers the use of mesenchymal stem cells, including the company’s intravenous Prochymal product, to treat inflammatory conditions in the gastrointestinal tract, including Crohn’s disease and ulcerative colitis.

Under Australian law, the opponent’s identity was not disclosed, Osiris said in a news release.

Actually, the challenge was filed in November by a patent attorney, Gavin Recchia. But under Australian law, such challenges may be filed by anyone, including those without a commercial interest, Victor Portelli of the Australian patent agency said. However, the client of the filer need not be disclosed, at least initially.

The challenge was withdrawn this month before any supporting evidence was filed.

Last year, Prochymal became the world’s first stem cell drug approved by an internationally recognized regulatory authority. It’s also approved to treat acute graft versus host disease, a serious complication of bone marrow transplantation that kills up to 80 percent of children affected, many soon after diagnosis, according to Osiris. Canada and New Zealand have approved it, and it’s also available in the U.S. and six other nations under an expanded access program.

Osiris also reported the European Medicines Agency has designated it as the orphan drug title holder for Prochymal for treating graft versus host disease. The designation provides incentives, such as market exclusivity for up to 10 years following approval.

Osiris stock rose 9 percent on the news Tuesday, before falling back Wednesday and Thursday.

In other Maryland bioscience industry news:

With a phase 3 trial of its personalized brain cancer vaccine already under way at 41 U.S. sites, Northwest Biotherapeutics took a major step in advancing its European studies.

The Bethesda biotech has inked a deal with Paraxel of Boston, a contract research organization, to manage its 312-patient phase 3 trial in the U.K. and elsewhere in Europe.

That trial is expected to being enrolling patients in the U.K. this quarter and in Germany within several months.

“After three years of extensive preparatory work, this is an important milestone and a reflection of the exciting potential of this trial,” CEO Linda F. Powers said in a statement. “We are fortunate to have a large number of marquee institutions as partners in Europe, including the Fraunhofer Institute, Kings College Hospital and Sarah Canon Research Institute, among others.”

Northwest stock rose 15 percent on the news, before falling back.

Besides brain cancer, the biotech is studying its DCVax vaccines to treat prostate cancer and metastatic ovarian cancer.

Cytomedix, a Gaithersburg biotech focused on regenerative therapies and platelet and adult stem cell technologies, reported raising $27.5 million to help finance its activities this year.

“We are pleased with this capital infusion, as it provides us with the necessary capital to execute on our strategic growth plans,” CEO Martin Rosendale said in a statement. “This capital will facilitate our continued growth following the record product sales we achieved in the fourth quarter of 2012, the expansion of the AutoloGel System with Medicare coverage, and the international growth of the Angel cPRP System.”

The financing comprises a $7.5 million credit and security agreement with MidCap Financial, a $5 million registered offering involving certain existing institutional shareholders comprising members of its largest existing shareholder, Aldagen Holdings, and the state of Maryland Venture Fund, plus new institutional investors and a $15 million committed equity facility with Lincoln Park Capital Fund, which also participated in the $5 million offering.

Rexahn Pharmaceuticals this week provided investors an upbeat update on its goals for 2013.

“The infusion of $9 million from our recently completed public offering and research funding from Teva Pharmaceuticals for RX-3117 will enable the company to accelerate the clinical development of Archexin, RX-3117 and RX-5902, while advancing three pre-clinical compounds closer to clinical development,” CEO Peter D. Suzdak said in a statement. The candidates are being developed to treat cancer.

Under the Teva deal, Rexahn expects to receive additional milestone payments from Teva in the second half of 2013 with the submission of a new drug application to the Food and Drug Administration and patient enrollment in a phase 1 clinical trial.

The phase 1 study of RX-5902 will be to treat solid tumors, such as melanoma and cancers of the ovary, kidney and pancreas.

Rexahn also plans to launch a phase 2 clinical trial of Archexin, which has shown promise in treating pancreatic cancer.

Neuralstem has granted licenses to intellectual property invovling its spinal cord delivery platform, floating cannula and method for delivering therapeutic agents to the spinal cord to Cedars-Sinai Medical Center of Los Angeles.

The license is not exclusive; Neuralstem previously licensed the technologies to another entity. Terms were not disclosed.

The Rockville biotech is developing stem cell treatments for amyotrophic lateral sclerosis and spinal cord injuries.

“This second set of licenses for our devices further demonstrates the growing acceptance of intraspinal delivery of therapeutics, once thought impossible, in the treatment of spinal cord conditions and diseases,” CEO Richard Garr said in a statement. “We have shown that it can be done safely in our (amyotrophic lateral sclerosis) trial in 15 patients and 18 procedures, in which three patients successfully returned for second transplants. We plan to continue our licensing program to industry and academia as they begin to explore the possibilities our technology has enabled.”

Sucampo Pharmaceuticals’ glaucoma treatment, approved by the FDA in December, is now available in the U.S.

Branded as Rescula, the prescription drug is for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Rescula might be prescribed as either an initial treatment or in conjunction with other topical ophthalmic drugs.