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University of Colorado Awarded US Patent for Cancer Rx; Viral Genetics Holds Option to Tech

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Biotech company Viral Genetics said last week that the University of Colorado has recently been issued what it believes to be the first US patent related to a new treatment for drug-resistant cancer known as metabolic disruption.

Viral Genetics, based in San Marino, Calif., holds an exclusive option to acquire the rights to the intellectual property, which adds to a portfolio of IP the company had previously licensed from CU, but represents a new direction for an ongoing collaborative research partnership between the entities, the company said.

The most recent patent, US No. 7,510,710, entitled "Compositions of UCP inhibitors, Fas antibody, a fatty acid metabolism inhibitor, and/or a glucose metabolism inhibitor," was issued in March.

The patent is based primarily on research conducted in the laboratory of Karen Newell, a professor of biology at the University of Colorado, Colorado Springs; however, the patent is assigned to the University of Colorado system, which handles tech transfer for its Colorado Springs, Boulder, and Denver campuses.

Metabolic disruption describes a method for treating cancers, including multi-drug resistant cancers, in which 2-deoxy-D-glucose is administered to a patient to inhibit high-rate glucose metabolism, which is characteristic of cancer cells.

The compound can be administered in combination with current, standard chemotherapy and/or in combination with etomoxir, an inhibitor of fatty acid oxidation. According to Viral Genetics, drug-resistant tumor cells commonly use fatty acid metabolism to meet their energy requirements, and disrupting either the glucose or fatty acid metabolism pathways can cause apoptosis of the cancer cells while sparing normal cells.

Haig Keledjian, CEO of Viral Genetics, told BTW this week that the patent is especially significant because "some of this technology, which has been around for several years, a lot of experts thought … was not patentable. It is significant that we are getting protection on it, and that we have ongoing research on this. Once a concept is given patent protection, it opens up the door for further research."

The patent also represents a new direction for an ongoing sponsored research collaboration between Viral Genetics and Newell's lab at UCCS.

"This is a new area for us," Keledjian said, adding that Newell has been studying metabolic disruption for some time, "but now we are looking at ways to develop this as quickly as possible."

In a statement, Newell said that the patent "represents the first method for treating drug-resistant cancer using metabolic disruption. We are very excited that the [USPTO] has recognized the significance of work we first pioneered over eight years ago."

Viral Genetics' relationship with Newell's lab dates back to at least 2007, when Viral Genetics formed a subsidiary called V-Clip Pharmaceuticals specifically to license innovations from Newell's lab at UCCS.

As part of the arrangement, Viral Genetics became the largest shareholder in V-Clip, which also had as shareholders University License Equity Holdings (CU's equity holding arm), Newell, and other CU researchers.

Viral Genetics and V-Clip's first licensing deal with CU, in December 2007, involved several patent applications related to the mechanism of action of Viral Genetics' flagship therapeutic candidate called thymus nuclear protein compound. Specifically, V-Clip acquired the rights to patent applications and know-how related to using TNP for diagnosing and treating HIV-AIDS, hepatitis C, and herpes (see BTW, 12/31/2007).

Then, in June of last year, V-Clip expanded its licensing agreement to include a pair of exclusive options to acquire rights for treating and detecting several forms of cancer, including lung, breast, leukemia, and others; as well as multiple sclerosis, diabetes, rheumatoid arthritis, malaria, and several other diseases (see BTW, 6/18/2007).

Keledjian said that forming V-Clip worked "as a test period for both us and the university to get to know each other, and to see if their technology worked with the technology we had."

Viral Genetics had seen some efficacy for its TNP compound in treating a variety of diseases in clinical trials in China, Mexico, and South Africa – but it didn't completely understand why its compound was working.

"To summarize plainly, she had an idea that fit with the product we had," Keledjian said. "She had a theory to sort of explain this, and we formed V-Clip to work together to see if this theory worked. We believed that she had the mechanism of action."

In November, Viral Genetics bought out the remaining 56 percent of V-Clip that it did not previously own from University License Equity Holdings, Newell, and colleagues. The financial details of that transaction were not disclosed, but Viral Genetics said that it now owns V-Clip's exclusive rights to patent applications based on Newell's work.

"It came to a point where we felt comfortable enough to sort of merge everything and move forward with her theories," Keledjian said.

The option to Newell's work in the area of metabolic disruption for cancer was included in the June 2007 option agreement, Keledjian said, but the company did not seriously consider moving forward with work in that area until the most recent patent was issued.

Keledjian told BTW that the technology is still under an option agreement, and Viral Genetics can eventually choose to negotiate an exclusive license for the therapy, though he didn't elaborate on the specific criteria for such a deal.

Viral Genetics also said that additional patents directed at generic classes of the drugs are still pending, and that its licenses and options with CU are in return for certain undisclosed obligations and fees.

Keledjian said that his company also continues to sponsor research in Newell's lab, and that she is a consultant to the company, although she retains a full-time faculty position with UCCS.

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