On December 16, 2004 Allos Therapeutics, Inc. (Nasdaq: ALTH) reported that it has acquired an exclusive worldwide license from the University of Colorado Health Sciences Center, the University of Salford and Cancer Research Technology to develop and commercialize a new chemotherapeutic agent known as RH1 (Press release, Cancer Research Technology, DEC 16, 2004, View Source [SID1234523440]). The compound is currently being investigated in a Phase 1 clinical trial sponsored by Cancer Research UK, the largest volunteer-supported cancer research organization in the world.
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RH1 is a targeted cytotoxic prodrug that is bioactivated by the enzyme DT-diaphorase (DTD), which is over-expressed in many tumors relative to normal tissue, including lung, colon, breast and liver tumors. The drug exhibits a similar mechanism of action to the potent chemotherapeutic agent Mitomycin C, with greater potential activity against cells expressing high DTD and a potentially more favorable safety profile. RH1 was a nominated compound for advancement in the National Cancer Institute’s Developmental Therapeutics Program (DTP), which provides cancer drug discovery and development resources to the intramural, academic and industrial research communities.
"Pre-clinical work has shown RH1 to be a more efficient substrate for DTD than currently available agents," said Dr. David Ross, Professor of Toxicology and Chairman, Dept. of Pharmaceutical Sciences at the University of Colorado. "This drug may offer a means to selectively target tumors expressing high levels of DTD."
RH1 is currently being evaluated in patients with advanced solid tumors refractory to other chemotherapy regimens in an open label, Phase 1 dose escalation study chaired by Dr. Malcolm Ranson, Director Derek Crowther Unit, Christie Hospital, Manchester, UK. Up to 40 patients will be enrolled to test the safety, tolerability and pharmacokinetics (PK) of escalating doses of RH1. Patient DTD enzyme levels are being measured to correlate with drug efficacy. Recruitment began in September 2003 and is expected to complete in the second half of 2005.
"We’ve enrolled nearly a third of the desired number of patients for the study and are encouraged by results seen to date from both a safety and efficacy standpoint," said Dr. Ranson.
Under the terms of the agreement, Allos will make an up-front payment and a series of milestone payments based upon the achievement of specified development, regulatory and commercialization goals. Allos will also make royalty payments based on product sales, if any, resulting from the collaboration. Cancer Research UK will continue to support the ongoing Phase 1 dose escalation study, and Allos will have the right to obtain an exclusive license to the results of the study, for use in subsequent development and regulatory activities, upon payment of a one-time data option fee. Upon completion of the Phase 1 study, Allos will assume responsibility for all further development costs and activities. Financial terms of the transaction were not disclosed. However, Allos does not expect the in- licensing of RH1 to result in a material increase in its quarterly operating expenses for at least the next 18-24 months.
"We’re excited to add this novel compound to our growing oncology portfolio," said Michael E. Hart, President and Chief Executive Officer of Allos. "RH1 complements our current development programs and will allow us to capitalize on our in-house clinical, regulatory and manufacturing expertise."