Staff Writer

GB Therapeutics is all about Smart Nitrates - something its CEO calls a "third generation" of about 150 nitric oxide-based compounds designed to treat central nervous system diseases, such as Alzheimer's disease or cardiovascular diseases.

The Mississauga, Ontario-based company was founded in 1997 on the research of scientists at Queen's University in Kingston, Ontario. Although new CEO Anthony Giovinazzo was announced in January, the five founding scientists continue to support the company.

"The platform offers the opportunity to identify potential drug candidates for both cardiovascular and CNS diseases," Giovinazzo said. "The platform is based on chemistry that has looked at nitrate-based compounds and addressed some of the issues and side effects associated with those compounds to create a novel and new class - we call it a third-generation approach."

Drugs such as nitroglycerin have been around for about 120 years to promote vessel dilation associated with angina, he said. But with Smart Nitrates, the molecules are different in that they are "novel chemical entities and they have been engineered with certain properties to have some tissue selectivity."

With its rational design process, GB Therapeutics removed the vessel dilation properties.

"What these molecules actually do is provide the mimicking of what nitric oxide does in cells, and we do that through a combination used in the creation of molecules that does not require the biotransformation that is normally associated with nitric oxide," he said.

The molecules have been tested in "various industry-approved animal models of disease," he said, and "they've demonstrated positive results."

GT 1061 is the company's lead candidate and it is designed to treat mild to moderate Alzheimer's disease.

"We anticipate being able to file an [investigational new drug application] in early 2004 and complete a Phase I test in 2004," he said, noting that the company's plan is to move to a Phase IIa before the end of 2005, with Phase IIb beginning in late 2005 or early 2006.

The company also has a molecule called GT 015 that is not as far along in development.

"I'm very exited about this molecule," Giovinazzo said, adding that the compound has demonstrated the interesting property of neuroprotection that also protects against ischemia.

"So, it might be a molecule that one could use in cardiac bypass surgery, where you want a molecule that protects against microemboli and the death of neurons," he said.

In January, the company reported that it had received C$4.5 million (US$3 million), of C$8 million committed by VenGrowth Capital Partners, of Toronto. GB Therapeutics is scheduled to receive the second half of the C$8 million once it raises C$12 million from other investors to complete the Series A. Giovinazzo said he expects the company will be able to close the round in April or May. University Medical Discovery Investments, also of Toronto, has invested about C$500,000. VenGrowth General Partner and lead manager of the VenGrowth Advanced Life Sciences Fund, Luc Marengere, joined the GB Therapeutics board.

The combined C$20 million Series A would provide enough cash for three years and enable the company to complete a Phase IIa study with an additional six months of "runway" to prepare for Series B financing, he said.

Regarding the potential for raising the money in a short timeframe, Giovinazzo said: "One is never confident. This is a difficult environment, but on the other side of the coin, we have a very experienced lead investor in the sense that he has a fund and has made a large investment in the company. And we have technology that has resulted in a lead candidate that we will quickly move to Phase IIa."

The company's intellectual property position includes five issued patents and 10 pending patents, he said.

GB Therapeutics has eight full-time employees, and plans to continue operating on a "semi-virtual basis," Giovinazzo said.

"We will have a small internal staff and outsource a number of functions and capabilities," he said. "We will work with a CRO to complete Phase I and II studies, but we will not create a large clinical development team internally in the next 24 months."