美国1999年开发中的抗癌新药

1999 Cancer N E W M E D I C I N E S I N D E V E L O P M E N T F O R Survey P R E S E N T E D B Y A M E R I C A Õ S P H A R M A C E U T I C A L C O M P A N I E S Can we declare victory in the war on cancer?“Wars are never won just like that – they’re a series ofbattles and skirmishes,” says cancer researcher Dr. Derek Raghavan of the University of California at Los Angeles. “If this were World War II, this would be 1943. We’re about three quarters of the way there.” Pharmaceutical research, by developing formidable weapons against cancer, has played a key role in the progress against this disease. And a new survey found 354 additional medicines in development for cancer. The medicines include 63 for breast cancer, which strikes one out of every 10 American women; 58 for skin cancer including melanoma, the most serious form of skin cancer, whose incidence has grown 4 percent a year since the 1970s; 58 for lung cancer, the leading cause of cancer death in the U.S.; and 46 for colon cancer, the second leading cancer killer of both men and women. These medicines in development should accelerate the progress that is already being made. For the second year in a row, the Centers for Disease Control reported in 1999 that death rates from cancer are falling. Particularly notable are declining death rates from breast cancer, prostate cancer, lung cancer, colon cancer and leukemia. Better treatments, including more powerful and targeted prescription drugs, are a major factor in the decline. Scientists are expressing even more hope for the future, as researchers unravel the mystery of how cancer works. “Cancer is no longer a black box. Pharmaceutical industry researchers have opened the box and are zeroing in on what makes cancer tick ... and how to stop this disease in its tracks,” says Robert Kramer, Ph.D., pharmaceutical company researcher. Building on the growing knowledge of how cancer works, pharmaceutical and biotechnology companies are working on a number of novel and promising ways to fight the disease. For example: • At least a dozen drugs that strangle the blood vessels that feed tumors. Last year, Harvard University researchers made headlines by successfully shrinking tumors in mice by this method. Efforts to turn this experiment into a medicine for human cancer patients have proved difficult, but now there are clinical trials being conducted on various drugs that use this mechanism to fight multiple myeloma, lung cancer, prostate cancer, kidney cancer, melanoma and other cancers. • A vaccine made from a patient’s own surgically removed colon tumor that is injected into the patient to boost the immune system to fight a recurrence of the cancer. According to a study published in the Lancet, a leading British medical journal, the vaccine reduced the five-year recurrence rate by 61 percent. • A protein that may be able to inhibit the toxic effects of chemotherapy on non-cancerous cells, allowing doctors to give patients higher, more effective doses of anti-cancer drugs. Despite all the progress made against cancer, it is still the second leading killer of Americans, surpassed only by heart disease. Cancer will claim an estimated 560,000 American lives this year. It costs $107 billion annually. These daunting figures mean that we must escalate the war against cancer. In the words of Secretary of Health and Human Services Donna Shalala, “Our battle is far from over – we must keep fighting this disease with everything we’ve got.” Pharmaceutical and biotechnology companies are investing billions of dollars to look for and develop new weapons against cancer. This commitment, coupled with the quickly growing knowledge of how the disease works, represents tangible hope of winning the war on cancer. Alan F. Holmer President PhRMA 354 New Weapons Are in Development for the War on Cancer MEDICINES IN DEVELOPMENT FOR CANCER* *Some medicines are l is ted in more than one category. Unspecified Cancers Other Cancers Cancer-Related Conditions Stomach Cancer Solid Tumors Skin Cancer Sarcoma Prostate Cancer Pancreatic Cancer Ovarian Cancer Neuroblastoma Multiple Myeloma Lymphoma Lung Cancer Liver Cancer Leukemia Kidney Cancer Head/Neck Cancer Colon Cancer Cervical Cancer Breast Cancer Brain Cancer Bladder Cancer 13 23 63 11 46 23 18 38 8 58 37 5 2 41 22 47 6 58 49 12 37 20 21 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 1 2 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 New Medicines in Development for Cancer B L A D D E R C A N C E R Product Name Company Indication Development Status 9-aminocampto- National Cancer Institute (see also breast, leukemia, lung, Phase II thecin (9-AC) Bethesda, MD lymphoma, ovarian, stomach) N C I T R I A L IDEC Pharmaceuticals San Diego, CA adenoviral p53 Introgen Therapeutics (see also brain, breast, liver, Phase I Austin, TX ovarian, prostate) Rhone-Poulenc Rorer Collegeville, PA National Cancer Institute Bethesda, MD ATRAGEN® Aronex Pharmaceuticals (see also kidney, leukemia, Phase I/II tretinoin The Woodlands, TX lymphoma, prostate, skin) BCI Immune Intracel Phase III Activator Rockville, MD modified keyhole limpet hemocyanin (KLH) BUDR National Cancer Institute (see also cervical, head/neck) Phase II Bethesda, MD N C I T R I A L Neopharm Lake Forest, IL C225, anti-EGFR Imclone Systems (see also breast, colon, head/neck, Phase I/II chimeric MAb Somerville, NJ kidney, lung, ovarian, pancreatic, prostate, other) Cotara Techniclone anaplastic astrocytoma, malignant Phase II TNT-tumor Tustin, CA glioblastoma, newly formed brain necrosis therapy cancer eflornithine ILEX Oncology superficial bladder cancer Phase III (DFMO) San Antonio, TX National Cancer Institute Bethesda, MD Gemzar® Eli Lilly (see also breast) Phase III gemcitabine Indianapolis, IN Levulan® PD DUSA Pharmaceuticals enhanced detection of bladder Phase I/II Valhalla, NY cancer (see also skin) pyrazoloacridine National Cancer Institute (see also breast, cervical, lung, ovarian, Phase II Bethesda, MD pancreatic, skin, solid tumors) N C I T R I A L Radinyl® Roberts Pharmaceutical (see also lung, Phase III ethanidazole Eatontown, NJ cancer/chemotherapy) Valstar™ Anthra Pharmaceuticals papillary bladder cancer Phase III valrubicin Princeton, NJ (see also ovarian) 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 2 3N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R A I N C A N C E R Product Name Company Indication Development Status adenoviral p53 Introgen Therapeutics (see also bladder, breast, liver, Phase I Austin, TX ovarian, prostate) Rhone-Poulenc Rorer Collegeville, PA National Cancer Institute Bethesda, MD alanosine Triangle Pharmaceuticals glioma Phase II Durham, NC (see also lung) allogeneic glioma The Immune Response newly diagnosed glioblastoma Phase I cancer vaccine Corporation multiforme or anaplastic Carlsbad, CA astrocytoma Camptogen SuperGen (see also breast, cervical, colon, Phase II rubitecan San Ramon, CA head/neck, leukemia, liver, lung, (RFS 2000, 9-nitro- lymphoma, ovarian, pancreatic, camptothecin) prostate, skin, stomach, other) chemotherapy- Genetix Pharmaceuticals (see also breast, ovarian, other) Phase I/II resistant bone Cambridge, MA marrow MDR gene CI-980 National Cancer Institute (see also leukemia, lung) Phase I/II Bethesda, MD N C I T R I A L Warner-Lambert Morris Plains, NJ gallium nitrate National Cancer Institute (see also lymphoma) Phase II Bethesda, MD N C I T R I A L Gliadel Wafer Guilford Pharmaceuticals primary malignant glioma Phase III polifeprosen Baltimore, MD at initial surgery carmustine Rhone-Poulenc Rorer Collegeville, PA IUDR National Cancer Institute Phase I Bethesda, MD N C I T R I A L Neopharm Lake Forest, IL IV hydroxyurea National Cancer Institute Phase II Bethesda, MD N C I T R I A L Bristol-Myers Squibb Princeton, NJ mitalactol Biopharmaceutics (see also cervical) Phase III Bellport, NY NBI-3001 Neurocrine Biosciences recurrent glioblastoma Phase I (interleukin-4 San Diego, CA pseudomonas exotoxin) Neu-Sensamide™ OXiGENE glioblastoma Phase II New York, NY (see also lung) phenylacetate National Cancer Institute Phase II Bethesda, MD N C I T R I A L Elan Pharmaceuticals S. San Francisco, CA 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 3 4 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R A I N C A N C E R Product Name Company Indication Development Status phenylbutyrate National Cancer Institute (see also colon, leukemia, Phase I/II Bethesda, MD lymphoma) N C I T R I A L Elan Pharmaceuticals S. San Francisco, CA RMP-7™ Alkermes in patients with brain tumors to Phase III Cambridge, MA permeabilize the blood-brain barrier (in combination with carboplatin) RSR13 Allos Therapeutics brain metastases, glioblastoma Phase II Denver, CO multiforme (see also lung) SU101 SUGEN malignant glioma Phase III S. San Francisco, CA (see also lung, ovarian, prostate) Temodal Schering-Plough anaplastic astrocytoma, application submitted temozolomide Madison, NJ glioblastoma multiforme (see also skin, solid tumors) temozolomide National Cancer Institute (see also lymphoma) Phase II Bethesda, MD N C I T R I A L Thalomid™ National Cancer Institute glioblastoma Phase II thalidomide Bethesda, MD (see also breast, prostate, skin) N C I T R I A L Celgene Warren, NJ trans-retinoic acid National Cancer Institute (see also head/neck, leukemia, Phase II Bethesda, MD prostate, skin) N C I T R I A L Xerecept™ Neurobiological reduction of brain edema Phase II corticotropin- Technologies associated with brain tumors releasing factor Richmond, CA (peritumoral brain edema) (CRF) B R E A S T C A N C E R Product Name Company Indication Development Status 2B1 bispecific National Cancer Institute (see also solid tumors) Phase II murine MAb Bethesda, MD N C I T R I A L 776C85 Glaxo Wellcome refractory breast cancer Phase II 5-fluorouracil (FU) Rsch. Triangle Park, NC (see also colon, pancreatic) enhancer 9-aminocampto- National Cancer Institute (see also bladder, leukemia, lung, Phase II thecin (9-AC) Bethesda, MD lymphoma, ovarian, stomach) N C I T R I A L IDEC Pharmaceuticals San Diego, CA 9-cis-retinoic National Cancer Institute (see also skin) Phase I/II acid Bethesda, MD N C I T R I A L adenoviral p53 Introgen Therapeutics (see also bladder, brain, liver, Phase I Austin, TX ovarian, prostate) Rhone-Poulenc Rorer Collegeville, PA National Cancer Institute Bethesda, MD Annamycin Aronex Pharmaceuticals refractory breast cancer Phase I/II anthracycline The Woodlands, TX 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 4 5N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R E A S T C A N C E R Product Name Company Indication Development Status APC 8024 Dendreon Phase I Seattle, WA Arimidex® Zeneca Pharmaceuticals first-line and adjuvant treatment Phase III Wilmington, DE Aromasin Pharmacia & Upjohn Phase III/ exemestane Bridgewater, NJ application submitted (aromatase inhibitor) BIBH 1 Boehringer Ingelheim (see also colon, head/neck, lung) Phase I Pharmaceuticals Ridgefield, CT BMS-217380 Bristol-Myers Squibb (see also prostate) Phase III (tesmilifene Princeton, NJ hydrochloride) Bondronate Hoffmann-La Roche Phase II/III ibandronate Nutley, NJ BP16 vaccine Biomira Phase I Edmonton, Alberta C225, anti-EGFR Imclone Systems (see also bladder, colon, head/neck, Phase I/II chimeric MAb Somerville, NJ kidney, lung, ovarian, pancreatic, prostate, other) Camptogen SuperGen (see also brain, cervical, colon, Phase II rubitecan San Ramon, CA head/neck, leukemia, liver, lung, (RFS 2000, 9-nitro- lymphoma, ovarian, pancreatic, camptothecin) prostate, skin, stomach, other) carcinoembryonic National Cancer Institute (see also lung, stomach) Phase I antigen peptide-1 Bethesda, MD N C I T R I A L vaccine CCI 779 Wyeth-Ayerst Laboratories (see also colon, pancreatic) Phase I Philadelphia, PA CEA-Scan® Immunomedics (see also lung) Phase II Morris Plains, NJ chemotherapy- Genetix Pharmaceuticals advanced breast cancer Phase I/II resistant bone Cambridge, MA (see also brain, ovarian, other) marrow MDR gene dolastatin 10 National Cancer Institute advanced breast cancer Phase I Bethesda, MD N C I T R I A L DOXIL®/Caelyx ALZA (see also ovarian) Phase II/III doxorubicin HCl Palo Alto, CA Stealth® liposome Schering-Plough injection Madison, NJ E/A lipid complex Targeted Genetics (see also ovarian, solid tumors) Phase I Seattle, WA emitefur Otsuka America refractory breast cancer Phase I/II Pharmaceutical (see also colon, pancreatic) Rockville, MD ERA 923 Wyeth-Ayerst Laboratories Phase I (tissue-selective Philadelphia, PA estrogen) 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 5 6 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R E A S T C A N C E R Product Name Company Indication Development Status Ethyol® U.S. Bioscience chemotherapy and radiation therapy Phase II/III amifostine W. Conshohocken, PA protective agent to reduce toxicity (see also head/neck, lymphoma, skin) EVACET™ The Liposome Company metastatic breast cancer application submitted liposomal Princeton, NJ doxorubicin Evista® Eli Lilly breast cancer prevention Phase III raloxifene Indianapolis, IN Exisuland Cell Pathways prevention of recurrence of breast Phase II/III W. Conshohocken, PA cancer (see also colon, lung, prostate, other) Faslodex® Zeneca Pharmaceuticals Phase III Wilmington, DE Femara Novartis Pharmaceuticals Phase III letrozole East Hanover, NJ fenretinide National Cancer Institute (see also solid tumors) in clinical trials Bethesda, MD N C I T R I A L R.W. Johnson Pharma- ceutical Research Institute Raritan, NJ G3139 Genta (see also colon, lung, lymphoma, Phase I/II (phosphorothioate Lexington, MA prostate, skin) antisense oligonuc- leotide) Gemzar® Eli Lilly (see also bladder) Phase III gemcitabine Indianapolis, IN HER-2/neu National Cancer Institute (see also colon, ovarian, prostate) Phase I peptide vaccine Bethesda, MD N C I T R I A L Hexalen® U.S. Bioscience (see also leukemia, lung, lymphoma, Phase II altretamine W. Conshohocken, PA ovarian) idoxifene SmithKline Beecham Phase II Philadelphia, PA Incel™ Vertex Pharmaceuticals (see also lung, ovarian, Phase II bricodar dicitrate Cambridge, MA prostate, sarcoma) (multi-drug resistance inhibitor) MAb antibody 3A1 National Cancer Institute Phase I Bethesda, MD N C I T R I A L MAb CC-49 National Cancer Institute (see also lung, ovarian) Phase I (LU-177) Bethesda, MD N C I T R I A L (Y-90) Dow Chemical Midland, MI MDR-1 transduced National Cancer Institute Phase I bone marrow cells Bethesda, MD N C I T R I A L MDX-H210 Medarex (see also colon, kidney, Phase I Annandale, NJ ovarian, prostate) MGI 114 MGI PHARMA (see also colon, kidney, lung, Phase II 6-hydroxymethyl- Minnetonka, MN ovarian, pancreatic, prostate, other) acylfulvene 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 6 7N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R E A S T C A N C E R Product Name Company Indication Development Status multitargeted Eli Lilly (see also colon, lung) Phase III antifolate Indianapolis, IN Neutrexin™ U.S. Bioscience (see also colon, lung, prostate, Phase II trimetrexate W. Conshohocken, PA stomach) glucuronate Novantrone® Immunex metastatic breast cancer Phase II/III mitoxantrone Seattle, WA (see also lymphoma, ovarian) Oncolar Novartis Pharmaceuticals Phase III octreotide pamoate East Hanover, NJ Ovidrel™ Serono Laboratories Phase II recombinant Norwell, MA human chorionic gonadotropin p53 and RAS National Cancer Institute (see also head/neck, lung, ovarian, Phase I vaccine Bethesda, MD pancreatic, solid tumors) N C I T R I A L Panretin® Capsules Ligand Pharmaceuticals (see also leukemia, ovarian, prostate, Phase III alitretinoin San Diego, CA skin, other) (LGD 1057) perillyl alcohol Endorex (see also ovarian, prostate) Phase II (POH) Lake Bluff, IL monoterpenes pure anti-estrogen Schering-Plough Phase III Madison, NJ pyrazoloacridine National Cancer Institute (see also bladder, cervical, lung, Phase II Bethesda, MD ovarian, pancreatic, skin, N C I T R I A L solid tumors) rV-MUC-1 Therion Biologics Phase I Cambridge, MA Sandostatin LAR® National Cancer Institute (see also sarcoma) in clinical trials octreotide Bethesda, MD N C I T R I A L pamoate Novartis Pharmaceutical East Hanover, NJ SGN-10 Seattle Genetics (see also colon, lung, ovarian, Phase I BR46 sFvPE40 Seattle, WA pancreatic, prostate) Targretin® Capsules Ligand Pharmaceuticals (see also head/neck, kidney, lung, Phase III bexarotene San Diego, CA lymphoma, ovarian, skin) (LGD 1069) Thalomid™ National Cancer Institute (see also brain, prostate, skin) Phase II thalidomide Bethesda, MD N C I T r i a l Celgene Warren, NJ Theratope® Biomira metastatic breast cancer Phase III therapeutic Edmonton, Alberta (see also colon, ovarian) vaccine Chiron ------------------------------------------------------------------------------------- Emeryville, CA in combination with alpha interferon Phase II Tirazone Sanofi Pharmaceuticals refractory breast cancer Phase II tirapazamine New York, NY (see also head/neck, lung, pancreatic) 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 7 8 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 B R E A S T C A N C E R Product Name Company Indication Development Status TriAb™ Titan Pharmaceuticals metastatic breast cancer Phase II/III anti-idiotype S. San Francisco, CA antibody troxacitabine BioChem Pharma (see also colon, kidney, leukemia, Phase II Laval, Quebec lung, ovarian, pancreatic, prostate, CliniChem Development skin) Montreal, Quebec vaccinia-CEA National Cancer Institute (see also lung, stomach) Phase I vaccine (180KD) Bethesda, MD N C I T R I A L Therion Biologics Cambridge, MA Xeloda® Hoffmann-La Roche (see also colon) Phase III capecitabine Nutley, NJ in combination with Taxol® C E R V I C A L C A N C E R Product Name Company Indication Development Status bryostatin 1 National Cancer Institute (see also kidney, leukemia, Phase I/II Bethesda, MD lymphoma, multiple myeloma, N C I T R I A L ovarian, skin) BUDR National Cancer Institute (see also bladder, head/neck) Phase II Bethesda, MD N C I T R I A L Neopharm Lake Forest, IL Camptogen SuperGen (see also brain, breast, colon, Phase II rubitecan San Ramon, CA head/neck, leukemia, liver, lung, (RFS 2000, 9-nitro- lymphoma, ovarian, pancreatic, camptothecin) prostate, skin, stomach, other) HPV16 E6 and E7 National Cancer Institute Phase I peptide vaccine Bethesda, MD HPV E7 lipopep- National Cancer Institute Phase I tide vaccine Bethesda, MD N C I T R I A L HspE7 StressGen Biotechnologies cervical dysplasia (CIN II/III) Phase I (SGN-00101) Victoria, British Columbia interleukin-12 National Cancer Institute (see also lymphoma, multiple Phase I/II Bethesda, MD myeloma, ovarian, skin) N C I T R I A L Genetics Institute Cambridge, MA LGD 1550 Ligand Pharmaceuticals (see also head/neck) Phase II San Diego, CA MEDI-501 MedImmune prevention of cervical cancer in clinical trials HPV-11 vaccine Gaithersburg, MD SmithKline Beecham Philadelphia, PA mitalactol Biopharmaceutics (see also brain) Phase III Bellport, NY pyrazoloacridine National Cancer Institute (see also bladder, breast, lung, Phase II Bethesda, MD ovarian, pancreatic, skin, N C I T R I A L solid tumors) 99128-PhRMA/NewMeds/Cancer 5/7/99 1:16 PM Page 8 9N E W M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 1999 C O L O N C A N C E R Product Name Company Indication Development Status 776C85 Glaxo Wellcome colorectal cancer Phase II 5-fluorouracil (FU) Rsch. Triangle Park, NC (see also breast, pancreatic) enhancer 8C1.cAMP ICN Pharmaceuticals Phase I Costa Mesa, CA allogeneic colon The Immune Response metastatic colorectal cancer Phase I