Lowe inks new deal for clinical trials of another cancer drug
Businessman and scientist Dr Henry Lowe, who has a series of cancer drugs in various stages of development under different partnerships, announced his second deal to conduct clinical trials in as many months.
The latest will see Educational and Scientific LLC, ESL, conduct stage three clinical trials covering some 1,000 persons across several countries to test a drug called Galeterone, which was developed by the University of Maryland along with a private entity formerly called Tokai Pharmaceuticals, for treatment of prostate cancer. ESL is a Baltimore, Maryland-based commercial venture established by Lowe to conduct research and development of medicines.
The trials, being done in collaboration with the University of Maryland-Baltimore (UMB) should run for 24 months starting in early 2019, while the cost could range anywhere from US$10 million to US$100 million, depending on the locations and parameters for the study, said Lowe, who is currently in the United States.
"We are closer to the lower end of that range," he said on Tuesday.
The financing of the project will include private placements and investments from the various countries from which the trials will originate.
"And the returns will be quick. We are talking about 24 months before it will go to market," he said.
ESL will have the option to take the drug to market, and pay the University of Maryland a royalty fee; or sell to a large pharmaceutical company, he added.
Lowe projects that the drug could rack up US$500 million in sales, annually - an estimate based on the US$2.5 billion earned from two other major prostate cancer drugs already on the market. The Galeterone drug could earn around 20 per cent of that, he reasoned.
"The university could have chosen other companies, but chose us. It shows that they trust us to take this drug forward to final stage of the process," said Lowe.
Galeterone is a molecule that was discovered and put into early preclinical development by co-inventors Dr Vincent Njar and the late Dr Angela Brodie at the UMB School of Medicine, for the treatment of hormone-sensitive prostate cancer.
UMB has effectively licensed the drug to ESL.
"We are delighted that ESL has licensed its second cancer therapeutic candidate from UMB," said UMB's chief enterprise and economic development officer and vice-president, Jim Hughes, in a joint press release.
ESL said Galeterone has already successfully completed two phases of clinical trials in the United States, and that a successful third trial, "which involves a larger scale study of at least 1,000 participants", would lead to commercialisation of the drug.
The first two trials were said to be conducted by Tokai Pharmaceauticals. The third by ESL is expected to get under way on or before the second quarter of 2019, with test patients from Jamaica, and countries in Africa, North America and Europe.
ESL is a member of the Eden Gardens Group of Companies held by Lowe and partners. Its initial project was the commercialisation of the Jamaican ball moss plant known scientifically as Tillandsia recurvata, which holds anti-cancer properties.
In early December, another of Lowe's companies, Medicanja Limited, received a $7-million front from the Development Bank of Jamaica - becoming the first entity to receive funding from a local lending institution for marijuana. That grant would support an overall US$300,000 investment to conduct stage two trials of another cancer drug, referred to only as 'Drug X'. The trials will seek to determine whether cannabis can treat pain for terminally ill cancer patients. That drug was developed by yet another of Lowe's companies, Bio-Tech R&D Institute, and the trials will be conducted in collaboration with The University of the West Indies.
Another member of the Eden Gardens family, called Flavocure LLC, received a US$5.75-million injection of capital in November from Canadian firm Atlas Biotechnologies Inc, in return for a 20 per cent stake in the operation. The move values Flavocure at some US$29 million ($3.7 billion).
Last year, Flavocure received preclinical trial approval for a cannabis drug it developed called Cresorol. That drug, which targets acute myeloid leukaemia, received US Food and Drug Administration orphan-drug status last June to be developed as treatment of a rare disease or illness. The designation allows Flavocure to first proceed with clinical trials, and then commercialisation of the drug.