Numerous novel oncology agents are currently in phase I monotherapy trials. New Medicine's Oncology KnowledgeBASE (nm|OK) has updated the records of 92 such agents with preclinical or clinical results reported during the following 2005 meetings: American Association for Cancer Research (AACR) • American Society of Clinical Oncology (ASCO) • American Society of Hematology (ASH) • AACR-NCI-EORTC meeting on Molecular Targets and Cancer Therapeutics.

The majority of these agents are novel targeted therapeutics addressing, in addition to well established targets such as the epidermal growth factor receptor (EGFr) and vascular endothelial growth factor receptor (VEGFr) tyrosine kinases, numerous first-in-human targets. Among these novel drugs are various multitargeted agents and those blocking such targets as: Aurora • polo-like kinase I (plk1) • transferrin • stromal-derived factor 1 (SDF-1) • insulin-like growth factor-1 (IGF-1) • Met • nucleolin • mitogen-activated protein kinase (MAPK)/ERK (MEK) • telomerase.

Depending on the results of these trials, many of these agents will proceed to phase II monotherapy clinical trials, as well as phase I trials in combinations with standard approved chemotherapeutics and other novel targeted drugs.

Two detailed tables are avaliable only to subscribers of the Oncology KnowledgeBASE:

• Anticancer Agents in Phase I Monotherapy Clinical Trials with Recently Reported Preclinical or Clinical Findings
• Molecular Targets of Anticancer Agents in Phase I Monotherapy Clinical Trials

The global market of branded anticancer drugs exceeded $23 billion in 2004. Revenues ranged from a few million dollars for some brands all the way to $2.815 billion for Rituxan/MabThera. Global sales of 9 drugs exceeded $1 billion in 2004. Growth of anticancer drugs continued strong in the first half of 2005.

In addition to anticancer agents, the oncology sector supported a multibillion dollar market for drugs used to treat complications of cancer and its treatment, including drugs to treat anemia, neutropenia, moderate-to-severe infection, moderate-to-severe pain, mucositis, hypercalcemia, among others.

The oncology global franchise has evolved into a dynamic marketplace where newly introduced agents rapidly grow to earn their development costs within a few years. However, competitive pressures will present new challenges as more drugs become approved and enter the market.

Subscriber Search Tip: To keep up to date on the latest informtation in nm|OK on 2004 sales of anticancer drugs, open the Marketed Drugs Query Screen. Select the Drug Sales Table report format, enter malignancy in the Therapeutic Category query text box, and 2004 in the Sales query text box.

The detailed table, Global Sales of Anticancer Agents in 2004 is avaliable only to Subscribers of the Oncology KnowledgeBASE.

New Medicine, Inc. has published in its analytical newsletter, Future Oncology, a comprehensive review of the role of the c-Src signal transduction pathway in malignancy and as a target for anticancer drugs.

Src is overexpressed and highly activated in a wide variety of human malignancies, and also appears to correlate with disease stage. Src activation has been documented in upwards of 50% of tumors derived from the colon, liver, lung, breast, and pancreas. There appears to be a significant relationship between Src activation and cancer progression, and Src may influence the development of the metastatic phenotype. Therefore, Src may play a role as a critical component of the signal transduction pathways that control cancer cell development and growth, making it a target in drug discovery efforts.

Note to Subscribers: To view agents in development targeting c-Src, enter src in the Targets field in the query screen of the New Drugs module. To learn about c-Src and malignancy, enter src in the Marker Designation field of the Targets in Oncology module.

View Future Oncology Volume 8#5 table of contents

Future Oncology, New Medicine’s premier analytical newsletter in the oncology sector, has published a 6-part series covering every aspect of the pancreatic cancer field. Topics covered include:

Epidemiology Molecular Markers Prognosis, Diagnosis and Disease Monitoring

State-of-the-Art Treatments Novel Cytotoxics, Targeted Therapeutics, Antimetastatic Agents, and Immunotherapy/Vaccines

In February 2005, New Medicine compiled a presentation on the role of targets in oncology drug development. The presentation includes information on drug categories, origins, and delivery options as well as concepts, tools and potential opportunities in oncology drug development.

• Slides from the presentation*
     includes Exhibit 1 - Targets of Approved Drugs
• Exhibit 2 - Putative Targets of Anticancer Agents Evaluated in Clinical Trials*
• Exhibit 3 - Additional Targets of Anticancer Agents Evaluated Preclinically*
• Exhibit 4 - Selected Cytotoxic Agents Evaluated in Clinical Trials by Target*
• Exhibit 5 - Selected Targeted Cytotoxic Anticancer Agents Having Entered Clinical Trials*

In summer 2003, Future Oncology, New Medicine's premier analytical newsletter, issued a comprehensive report on the status of randomized phase II/III clinical trials in oncology, incorporating reviews of presentations from the 2003 meeting of the American Society of Clinical Oncology (ASCO).
(View press release)

Table summarizing the "Selected Clinical Trial Status of Novel Drugs Being Evaluated in Combination With Cytotoxic Antibiotics". (View press release)

Extensive updates have been made to records of spindle poisons in the Oncology KnowledgeBASE. This is in conjunction with a 3-part series recently completed in Future Oncology, New Medicine's premier analytical newsletter. The series describes spindle poisons originating from various sources:

• natural product extracts
• synthetic/semisynthetic versions of natural extracts
• designed drugs that disrupt microtubule formation by interfering with tubulin
• designed drugs that disrupt microtubule formation by inhibiting the action of molecular motors

Table of detailed market estimates for taxanes, including global revenues for 1999 and 2000, and 2001 estimates for the USA and abroad. (View press release)

Global market data for 1997 and 2000 for 45 anticancer agents and 11 adjuncts belonging to 9 separate drug categories and various subcategories. (View press release)