Until last month, Allos Therapeutics Inc. was a company built around one compound, RSR13, which is being developed as a radiation sensitizer.
In March, Westminster, Colo.-based Allos announced that it was granted a license to intellectual property surrounding BGP-15, an orally available small molecule that reduces cellular stress induced by chemotherapy.
“We want to build Allos as an oncology company,” said Allos President and CEO Michael Hart, describing the reasoning for taking on the compound.
Hart, who was appointed to the positions in December, served as the company’s senior vice president of operations and chief financial officer since 1999. Before joining Allos, Hart was vice president and chief financial officer of NeXstar Pharmaceuticals Inc., before its acquisition by Gilead Sciences Inc., of Foster City, Calif., in 1999.
Hart describes Allos today as a virtual company, since it does not have a pure research and development platform, instead focusing on in-licensing compounds. Allos had $70 million in cash as of Dec. 31, Hart said, and a burn rate of $5 million to $6 million per quarter. With 73 employees, what it does have is clinical capacity and regulatory expertise.
Its lead compound, RSR13, is in late-stage Phase III trials for the treatment of metastatic brain tumors. RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin. There are 500 patients slated for the trial, and enrollment is expected to be completed in the second half of the year.
“The brain metastases indication is the one we have chosen to be our registration path to the market, but more importantly, [RSR13] has demonstrated an increase in median survival in glioblastoma multiforme and non-small-cell lung cancer,” Hart said.
The endpoint of the Phase III trial is survival, and if the trial meets the endpoint, Allos would file for a new drug application in the third quarter of 2003, he said. Assuming a year’s review by the FDA, it would put Allos in a position to launch the product in mid-2004.
If Allos receives approval in brain metastases, it plans to complete a Phase III trial in non-small-cell lung cancer with an eye toward expanding the label for RSR13. It is also being studied in surgery and cardiovascular areas, including angina and stroke.
Allos’ strategy is to outlicense RSR13 in Europe and Japan, but in the United States, it plans to market it on its own or through a partner. Allos is in the process of evaluating potential marketing partners.
“It is important to note that we would expect at a minimum to have a co-marketing arrangement,” Hart said.
In a move that Hart said was a first step in building an oncology pipeline, Allos acquired the development and marketing rights for BGP-15 in the United States from N-Gene Research Laboratories, a privately held company based in Budapest, Hungary. In return for those rights, Allos will make an initial equity investment in N-Gene, additional equity investments and licensee fee payments based on milestones, as well as paying royalties.
BGP-15 is in late-stage preclinical studies, Hart said, and Allos is preparing to file an investigational new drug application by the end of the year.
Allos’ CEO said he plans to continue to lead Allos toward its goal of being a cancer company, but with the added strategy of expanding through acquisitions.