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."

On November 2, 2004 Cancer Research Technology Limited (CRT), the specialist oncology focussed technology transfer and development company, reported the completion of a Technology Transfer Agreement with Marie Curie Cancer Care, one of the largest cancer charities in the UK (Press release, Cancer Research Technology, NOV 2, 2004, View Source [SID1234523444]).

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Under the terms of this agreement CRT has been granted an exclusive option to assist in the development and commercialisation of any cancer related discoveries arising from the Marie Curie Research Institute (MCRI), the research institute which is part of Marie Curie Cancer Care.

Dr Peter O’Hare, Director of the MCRI, said of this agreement. "This new agreement enhances our ongoing relationship with CRT. With MCRI research expertise in key areas of cancer biology and the expertise of CRT in technology development and commercialisation, together we aim to maximise opportunity for research to bring benefit to cancer patients."

This agreement positively expands their existing relationship, in part by enabling the MCRI to work directly with CRT’s Development Laboratory.

CRT is distinctive amongst technology transfer organisations in having its own development laboratory, with core competences in molecular and cellular biology, drug discovery, medicinal chemistry and early pharmacology. The laboratory plays a key role within CRT in adding value to a scientist’s initial invention, enhancing its potential for commercialisation and therefore cancer patient benefit.

The Marie Curie Research Institute specialises in cutting-edge research. Scientists work right at the boundaries of our existing knowledge, seeking to find out more about the cellular mechanisms responsible for the development of cancer. Their work may identify novel anti-cancer targets, or completely new therapeutic strategies? but further development is needed to convert experimental results into therapies that can be used in the clinic.

Dr Keith Blundy, CRT’s Chief Operating Officer added: "The signing of this Technology Transfer Agreement marks a significant and exciting milestone in our relationship with Marie Curie Cancer Care. Both organisations are united in their mission of seeking cancer patient benefit and CRT looks forward to joining forces with scientists at the MCRI to achieve this."

On October 12, 2004 Medical Solutions plc, (‘MLS’) the supplier of services for drug developers and healthcare providers, reported that it has entered into a strategic alliance with Cancer Research Technology Ltd (‘CRT’), to enhance the speed and reliability of early cancer drug development(Press release, Cancer Research Technology, OCT 12, 2004, View Source [SID1234523445]).

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CRT, is the technology transfer and development company of Cancer Research UK, Britain’s leading independent cancer research organisation.

Developing validated biomarkers to assess the response of a patient to a drug is now the critical step in drug development. MLS will use this exciting link to create a unique toolkit for their drug development service.

MLS will screen and assess a carefully selected sub-set of CRT’s monoclonal antibody panel to identify potential tissue biomarkers that will provide an indication as to the effectiveness of specific anti-cancer drugs.

There are currently in excess of 500 drugs in development for cancer with another 1,500 in late stage discovery. It is estimated that early phase biomarker driven clinical studies cost $20 million per drug so creating a global potential market of $40 billion for such services.

The intellectual property rights for any reagent will remain with CRT, and MLS will act as a joint partner in subsequent commercialisation for use in both drug development and in the creation of a novel diagnostic.

Harpal Kumar, CEO of CRT said: ‘We are delighted to be working with Medical Solutions. They have the necessary expertise to identify novel biomarkers to speed up the whole process of getting new drugs to patients’

Professor Karol Sikora, Scientific Director of MLS welcomed the agreement: ‘We are entering uncharted territory with the advent of molecularly targeted drugs. It is now vital to understand how to get the right drug to the right patient. CRT has an excellent panel of antibodies – an ideal starting point to create novel tissue diagnostics in an era of personalised medicine for cancer. For tomorrow’s patients the diagnostic is going to be as important as the treatment.’

On September 29, 2004 Cancer Research Technology Limited (CRT) and The Institute of Cancer Research reported that Vernalis plc has licensed exclusive worldwide rights to an anti-cancer Hsp90 inhibitor programme(Press release, Cancer Research Technology, SEP 29, 2004, View Source [SID1234523446]). The license arises from a successful tripartite research collaboration and option agreement entered into in March 2002, building on studies funded by Cancer Research UK, The Institute of Cancer Research and Wellcome Trust.

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Vernalis will pay CRT and The Institute of Cancer Research a signature fee, milestone payments, royalties on sales and a proportion of sublicensing fees. Subsequent to Vernalis signing the licence agreement with CRT and The Institute of Cancer Research, on 16 th September 2004, the company has entered into an exclusive collaboration and licence agreement with the Institute for Biomedical Research Inc (Novartis).

Hsp90, a chaperone protein, is of specific interest in anti-cancer drug development as many of the signalling proteins that behave aberrantly in cancer cells require Hsp90 to ensure that they are maintained in an active form.

Professor Paul Workman, Director of the Cancer Research UK Centre for Cancer Therapeutics and leader of the Hsp90 drug development project at The Institute of Cancer Research said: "Drugs that inhibit Hsp90 have the advantage of simultaneously blocking several different pathways that are vitally important for the growth and spread of most cancers. They therefore have the potential to benefit patients with many different types of cancer and to prevent the development of drug resistance which is major limitation of current treatments."

Keith Blundy, CRT’s Chief Operating Officer, commented: "I am delighted that the research collaboration between CRT, The Institute of Cancer Research and Vernalis has culminated in this license and furthermore that the continued development of Hsp90 inhibitors has been secured by the joint research venture between Vernalis and Novartis."

On August 12, 2004 Pharminox Limited, ("Pharminox" or "The Company") a private, small-molecule oncology research and development company that was formed out of Oxford University in 2002, has reported signing a second agreement with Cancer Research Technology Limited (CRT), the technology transfer company of the charity Cancer Research UK(Press release, Cancer Research Technology, AUG 12, 2004, View Source [SID1234523447]).

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The agreement gives Pharminox an exclusive 12-month option to licence the worldwide rights to Phortress, the lead compound in a class of novel anti-tumour agents, and related compounds for development and commercialisation.

Phortress, whose mechanism of action is distinct from all other classes of chemotherapeutic agents currently available, was discovered by Professor Malcolm Stevens and co-workers in his Cancer Research UK sponsored research group based at Nottingham University. Preclinical research studies have shown that Phortress is active in vivo against human breast, ovarian and colon xenografts. A Cancer Research UK sponsored Phase I trial to determine the maximum tolerated dose of Phortress has been initiated, under the direction of Professor Calvert at the Northern Centre for Cancer Treatment in Newcastle.

In December 2003 Pharminox signed it’s first licensing agreement with CRT, which gave the Company the worldwide development and commercialisation rights to a novel series of anti-tumour compounds known as quinols that are currently in preclinical development.

IP2IPO Group plc, the AIM listed intellectual property company that commercialises university technology, holds a 14% equity stake in Pharminox.

Commenting on the announcement, Sue Barrowcliffe, CEO of Pharminox, said: "The latest agreement with CRT provides access to a clinical stage compound and therefore represents a major step forward in the process of building Pharminox into an exciting oncology research and development company."

Professor Malcolm Stevens OBE, Cancer Research UK Professor of Experimental Cancer Chemotherapy and Chief Scientific Officer of Pharminox Limited, stated: "I am delighted that this small but dynamic UK company is to be given the opportunity to develop these very exciting novel anti-tumour agents. I am particularly pleased that this agreement will allow close co-operation with the inventors of the compounds through the critical early stages of development."

Harpal Kumar, CRT’s CEO, added: "I am pleased that CRT has had the opportunity to facilitate the continued development of this novel cancer chemotherapeutic under the auspices of Professor Stevens and in so doing strengthening our relationship with Pharminox."