Though it was formed only eight months ago, Tigris Pharmaceuticals Inc. already has in-licensed its first product candidate, started clinical trials and recently closed on its first round of financing, bringing in $11.6 million.

"It's been a very intense couple of months," said Edmundo Muniz, who joined Tigris in August as president and CEO. "We completed the Series A financing in record time, and the institutional investors who came in and financed us were very well known and established."

In addition, the company received a $2.3 million grant last month from the National Cancer Institute to fund continued research of its lead product, A-007, a topical treatment for cancer and precancerous anogenital lesions associated with the human papillomavirus (HPV). Tigris plans to begin a randomized, placebo-controlled Phase II trial later this year of A-007 in patients with high-grade cervical intraepithelial neoplasia. Within the next month, the company expects to initiate a Phase I trial of the product in patients with high-grade squamous intraepithelial lesions.

The first financing round "puts us in a very solid position," Muniz said. "We have enough money to finish two Phase II trials, and also cover comfortably our operational expenses."

Although the list of investors in the Series A are still undisclosed, Tigris was founded in February by venture capital firm Two River Holdings. As the first company to emerge from Two River, there are high expectations for Tigris to develop into "a high-quality creation," Muniz said.

"There's a lot of pride in the way we want to build this company," he added. "We want to make sure we take time to select the products, develop them well and thoughtfully and with enough cash in hand."

With the parent company being Two River, it seemed natural that the name of its spinout should stay in theme. "Tigris" refers to one of the two rivers that framed the early Mesopotamian civilization. The land between the Tigris and Euphrates rivers "was a source for sustainable development, and many parts of our current civilization are related to that land," Muniz said, adding that the founders of Tigris hope that it will come to "represent a source for sustainable clinical development" in the areas of cancer, infectious disease and women's health.

"The scope is very wide," he said, "and those three areas often interface with each other."

A-007, for instance, which in March was licensed from New Orleans-based DEKK-TEC Inc., is an immunomodulator aimed at both cancer and women's health. Tigris also in-licensed a number of A-007 analogues that are in varying phases of early development. Muniz estimated that the first of those will be ready to enter human trials "in the next year or so."

Though there are several competing products in development, Muniz said Tigris' drug is believed to be the most advanced topical product aimed at treating HPV-caused lesions, and many compounds in trials are prophylactic.

One of those is Whitehouse Station, N.J.-based Merck & Co. Inc.'s Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine.) Merck recently reported that in a Phase III trial, Gardasil prevented 100 percent of high-grade cervical precancers and noninvasive cervical cancers associated with HPV types 16 and 18 in women not infected with those types at trial enrollment. The trial is part of an ongoing Phase III program, involving 25,000 people worldwide. Pending overall results, Merck expects to submit a biologics license application for Gardasil before the end of 2005.

In addition to A-007, Tigris is in negotiations to bring additional compounds into its pipeline.

"At this point, we're licensing all of them," Muniz told BioWorld Today, "but the goal is to become a premiere biopharmaceutical therapeutics company through careful selection of high-quality molecules, thoughtful growth of in-house expertise and strategic outsourcing."

For now, the New York-based company remains small, though three members of its senior management are in place, including Muniz, who previously worked at Indianapolis-based Eli Lilly and Co. as the vice president of its Research Laboratories Global Oncology Platform. Joining him are two other Lilly alums: Anne White, who served as chief operating officer of the Infectious Diseases Production Team at Lilly, and now acts as COO and vice president of clinical operations; and Binh Nguyen, formerly executive director of Lilly's oncology platform team and of the pharmacogenomic program, and now Tigris' vice president of clinical development and regulatory affairs.

"We're very proud of the things we learned and the experience we gained while working in big pharma," Muniz said. "But at the same time, the world is going very fast, especially the world of clinical development and therapeutics.

"We've been able to couple the technical knowledge of big pharma with the agility and the sense of urgency of smaller entrepreneurial organization," he added.

For Muniz, going from the position of a global VP to CEO of a small entrepreneurial organization was a major shift.

"And I would not have made that decision unless I believed that the people behind Tigris had the courage and experience to frame it for success," he said, "and if I didn't believe that our first molecule could represent a significant solution for men and women who suffer from cancerous and precancerous lesions due to HPV."