Company* | Product | Description | Indication | Status (Date) |
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AltaRex Corp. (TSE:AXO) | OvaRex | Modified murine monoclonal antibody that binds to CA125 cancer antigen | Ovarian cancer | Company reported favorable early results in a Phase II trial (10/11) |
Amgen Inc. | Aranesp | Darbepoetin alfa | Anemia in cancer patients | Clinical data showed that Aranesp reduced fatigue scores in more than half of 517 patients treated (10/23) |
AnorMED | ZD0473 | New-generation platinum anticancer agent | Ovarian cancer | Phase II data showed a response rate of 39% in second-line platinum- sensitive ovarian cancer patients and 7% in second-line platinum- resistant patients (10/25) |
Antigenics | Oncophage | Cancer vaccine; uses heat shock proteins to activate cellular immune responses | Metastatic | Phase II data showed responses in five of 28 evaluable patients (10/31) |
Biomira | BLP25 | Vaccine; synthetic MUC1 therapeutic vaccine consisting of 25-amino-acid sequence of the MUC1 cancer mucin, encapsulated in liposomes | Prostate cancer | Company initiated a Phase II trial (10/19) |
Cell Genesys | GVAX | Vaccine; immuno-therapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor | Pancreatic cancer | Company initiated a Phase II trial (10/22) |
Cell Genesys | CG7870 | Oncolytic virus engineered to target and destroy prostate cancer cells | Advanced hormone- refractory prostate cancer | Company said a Phase I/II trial demonstrated antitumor activity after a single intravenous injection (10/23) |
Cell Path- | Aptosyn plus CPT-11 | Exisulind plus camptosar, irinotecan | Colorectal cancer and other solid tumors | Phase I data showed the combination to be generally well tolerated by patients (10/31) |
Cell Path- | CP461 | Oral drug; selective apoptotic antineoplastic drug | Chronic lymphocytic leukemia | Phase IIa data showed nine of 15 patients showed a reduction from baseline in their absolute lymphocyte counts (10/9) |
Cell Thera- | PG-TXL | Paclitaxel/polyglutamate polymer therapeutic | Advanced cancer | Preliminary results of two trials demonstrated that PG-TXL, given alone or in combination with cisplatin, shrinks tumors in patients who have failed standard treatments (10/31) |
Cell Thera- | Trisenox | Arsenic trioxide injection | Acute promyelocytic leukemia | Data revealed that Trisenox produced a 63% overall survival rate of patients at 24 months (10/5) |
ChemGenex | Ceflatonin | A natural product compound | Acute promyelocytic leukemia | Company began patient enrollment in a pilot Phase I/II study (10/29) |
Coley | CpG 7909 | DNA-based immune stimulant | Refractory metastatic breast cancer | Company initiated a Phase I/II trial of CpG 7909 in multidrug therapy with Genentech Inc.'s Herceptin (10/30) |
Cyclacel Ltd. | CYC202 | R-roscovitine; a small-molecule inhibitor of CD2 | Cancer | Company completed a Phase Ia evaluation and is entering Phase Ib trials (10/15) |
EntreMed | Angiostatin | Subcutaneous antiangiogenic | Advanced cancers | Phase I data showed Angiostatin is safe with no dose-limiting toxicity when combined with radiation therapy to treat advanced cancers (10/31) |
Genentech | Avastin | Bevacizumab; a humanized antibody to VEGF | Metastatic renal cell carcinoma | National Cancer Institute stopped recruitment in a Phase II trial because a monitoring board determined the trial had reached its efficacy endpoint at the second interim analysis (10/25) |
Genitope | Idiotype immunotherapy | Therapy includes a custom-made protein derived from each patient's tumor cells | Low-grade B-cell non-Hodgkin's lymphoma | Patients are being recruited for a Phase III trial (10/2) |
GenVec Inc. | TNFerade | Delivers tumor necrosis factor alpha gene directly to tumors using GenVec's adenovector technology | Soft tissue sarcoma | Company began treating patients in a Phase Ib trial (10/1) |
Geron Corp. | Telomerase | Antigen for cancer immunotherapy | Cancer | Company said Duke University Medical Center researchers initiated a Phase I trial (10/30) |
Kosan | Epothilone D | A polyketide that inhibits | Advanced solid tumors | Company initiated a Phase I trial (10/29) |
Lorus | GTI-2040 | Antisense anticancer therapeutic | Advanced or metastatic renal cell carcinoma | Company expanded the Phase II trial of GTI-2040 to be used with capecitabine (10/30) |
Matrix | IntraDose | Cisplatin/epinephrine | Solid tumors | Phase II results showed an overall response rate of 53% in patients with inoperable primary liver cancer, a response rate of 29% in patients with head and neck cancer and a response rate of 44% in patients with metastatic melanoma (10/23) |
Matrix | Tezacitabine | Nucleoside analogue that irreversibly inhibits ribonucleotide reductase and terminates DNA chain elongation | Acute myeloid leukemia | Company is moving forward with a Phase II study (10/11) |
Maxim | Ceplene | Histamine dihydrochloride; an adjuvant to interleukin-2 | Advanced metastatic melanoma | Follow-up data from a 305-patient Phase III trial, which evaluated Ceplene in combination with IL-2, were positive; the company still expects it will need to conduct another Phase III trial in order to bring Ceplene to the market (10/22) |
MGI Pharma | Irofulven | Anticancer compound | Ovarian cancer | Company expanded the ongoing Phase II trial (10/11) |
MGI Pharma | Palonosetron | A 5-HT antagonist | Chemotherapy- induced nausea and vomiting | Companies completed enrollment in the first Phase III trial (10/3) |
Millennium | LDP-341 | Small-molecule proteasome inhibitor | Multiple myeloma | Company completed enrollment of a Phase II trial (10/4) |
Millennium | J591 | Radiolabeled J591 | Advanced prostate cancer | Phase I data showed the therapeutic demonstrated antitumor activity (10/19) |
Nastech | Morphine gluconate | Nasal formulation | Pain in opioid- tolerant cancer patients | Company began enrollment in a Phase II trial (10/9) |
NeoPharm | Liposome Encapsulated Mitoxantrone | Uses NeoLipid drug delivery system | Cancer | Company initiated a Phase I/II trial (10/4) |
Novus- | BBR 3464 | Novel tri-platinum complex | Ovarian and non-small-cell lung cancer | Phase II results showed that some patients experienced responses and other signs of biological activity (10/22) |
OSI Pharma- | Tarceva (OSI-774) | Epidermal growth factor receptor tyrosine kinase | Metastasized pancreatic cancer and refractory non-small-cell lung cancer | Company began two more Phase III trials (10/24) |
Oxford | TroVax | Gene-based therapeutic vaccine designed to stimulate a patient's immune system | Colorectal cancer | Phase I/II results showed the drug to be safe and well tolerated, and vaccine induced an immune response against the tumor antigen OBA1 in colorectal cancer (10/15) |
OxiGene | CA4P | Combretastatin A4 prodrug; vascular targeting drug | Tumors | Phase I data showed statistically significant results demonstrating CA4P's ability to successfully reduce blood flow that feeds malignant tumors (10/31) |
Protein | Remitogen | SMART 1D10, apolizumab; humanized antibody | Non-Hodgkin's lymphoma or chronic lymphocytic leukemia | Company initiated a Phase I trial testing Remitogen in combination with IDEC Pharmaceutical Corp.'s Rituxan (10/29) |
Slil Biomed- | SL11047 | Second-generation polyamine analogue | AIDS-lymphoma | Company will begin a Phase I trial (10/23) |
Sonus Pharma- | S-8184 | Paclitaxel cancer product that used the company's vitamin E-based Tocosol delivery technology | Cancer | Phase I data indicate S-8184 can be given safely as a rapid injection and is well tolerated at higher doses than normally used with existing paclitaxel formulations (10/30) |
Telik Inc. | TLK286 | Small-molecule drug that targets tumors that over-express GST P1-1 | Colorectal, ovarian and non-small-cell lung cancer | Phase II data show TLK286 produces apoptosis in a concentration- and time-dependent manner (10/31) |
Transgene | MVA-HPV- | Anticancer vaccine; associates a pox virus vector derived from the modified virus ankara strain with antigens of the human papillomavirus type 16 | Cervical cancer | Company initiated a Phase II trial (10/18) |
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| CARDIOVASCULAR | ||||
Alliance | Oxygent | Perflubron emulsion | Cardiopulmonary bypass | Phase III cardiac surgery study results demonstrated oxygenation benefits (10/19) |
Alteon Inc. | ALT-711 | Orally active drug designed to reverse cardiovascular disease | Systolic hyper- tension and left ventricular hypertrophy | Company initiated a second Phase IIb (10/23) |
Centocor Inc. | Remicade | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Advanced congestive heart failure | Company placed a hold on further development based on Phase II results that showed there was no improvement in a patient's clinical status and a higher incidence of mortality and hospitalization (10/22) |
Esperion | ETC-642 | RLT Peptide product candidate | Cardiovascular disease | Company received approval to begin a Phase I trial (10/9) |
Texas Bio- | Argatroban | Anticoagulant therapy; synthetic direct thrombin inhibitor that blocks the activity of thrombin | For patients undergoing percutaneous coronary interventions | Companies initiated a Phase II trial (10/9) |
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| CENTRAL NERVOUS SYSTEM | ||||
AtheroGenics | AGIX-4207 | Intravenous treatment; small-molecule drug from AtheroGenics' v-protectant technology; a selective modulator of TNF-alpha- induced redox-sensitive inflammatory genes | Rheumatoid | Company initiated a Phase I trial (10/2); company completed the escalating single-dose segment of the Phase I trial (10/23) |
Axonyx Inc. | Phenserine | Acetylcholinesterase | Alzheimer's disease | Company reported positive safety and efficacy results from a Phase II study (10/30) |
Cellegy | Nitroglycerin | Nitroglycerin ointment | Genital pain caused by vulvadynia | All 12 patients in a study were relieved of pain within five minutes following application of the ointment; six women had a significant reduction of pain during sexual activity; the ointment was well tolerated, but most women experienced headaches (10/25) |
Genmab A/S | HuMax-IL15 | Fully human antibody | Active rheumatoid arthritis | Company initiated a Phase I/II trial (10/3) |
Pain Thera- | PTI-555 | Morphine | Moderate to severe pain | Phase II results showed the primary endpoint of pain relief was achieved (10/4) |
United Thera- | Beraprost | Oral therapeutic; form of prostacyclin, which is produced in blood vessels to keep them dilated and free of platelet aggregation | Intermittent claudication (pain while walking) | Beraprost failed to meet endpoints in peripheral vascular disease patients with intermittent claudication; the company is abandoning development plans (10/15) |
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| DIABETES | ||||
Generex | Oralin | Oral insulin formulation | Type I and Type II diabetes | Clinical data indicate that Oralin can be used safely and effectively in place of injected insulin (10/22) |
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| INFECTION | ||||
Cel-Sci Corp. | Multikine | Immunotherapy drug; natural mixture of human cytokines, including interleukin-2 | HIV and human papillomavirus- induced cervical dysplasia | Clinical data showed that all five women treated showed clinical improvement (10/9); Phase I results showed six of eight patients had no evidence of dysplasia on biopsy seven to eight weeks after final injection (10/30) |
Cerus Corp. | Intercept Red Blood Cell System | Pathogen inactivation | To protect against infectious diseases transmitted through red blood cell transfusions | Phase Ic results showed that the mean survival of the Intercept cells were 62.2 days, which is not statistically different from the 61.1 days of survival of untreated red blood cells (10/17) |
Cubist Pharma- | Cidecin | Daptomycin for injection | Skin and soft-tissue infections | Cidecin achieved its primary endpoint in a second pivotal trial (10/4); the company expects to file for regulatory approval in mid-2002 (10/26) |
DepoMed | Ciprofloxacin | Antibiotic delivered with DepoMed's Gastric Retention System | Urinary tract infections | Company initiated a Phase II trial (10/1) |
Enzo Biochem | EHT899 | Orally available viral protein | Chronic active hepatitis associated with hepatitis B | Phase II results indicate that the 42 individuals treated showed improvement in key areas of liver inflammation (10/12) |
Hollis-Eden | HE2000 | Immune-regulating hormone | Hepatitis B | Company received approval to initiate a Phase II trial (10/4) |
Inhale | Inhaleable tobramycin | An anti-infective drug; powdered tobramycin developed with Inhale's Inhance pulmonary delivery technology | Lung infections | Clinical results showed it was superior to nebulization when measuring delivery efficiency and lung deposition (10/2) |
IntraBiotics | Iseganan hydrochloride | Oral solution | Ventilator- associated pneumonia | Phase IIa results showed a 10-fold decrease in the mean oral microbial burden compared with negligible reductions in patients receiving placebo (10/4) |
MedImmune | Synagis (FDA- | Palivizumab; binds to fusion protein on viral surface | Respiratory syncytial virus | Data confirm that Synagis reduces the rate of RSV-related hospitalization among high-risk infants (10/22) |
Nexell Thera- | ¿ | Hematopoietic stem cells | Chronic granulomatous disease | Company began patient enrollment in a Phase III trial (10/22) |
Ribozyme | Heptazyme | Anti-hepatitis C ribozyme | Hepatitis C | Company began a Phase II trial (10/8) |
Xenova | TA-HSV | Vaccine | Genital herpes | The Phase II trial failed to meet its clinical endpoints; company decided to drop development for this indication (10/10) |
Xenova | TA-HPV | Vaccine | High-grade vulval intraepithelial neoplasia | Phase IIa results showed the vaccine was safe and well tolerated (10/26) |
Xenova | TA-CIN | Vaccine | Cervical intraepithelial neoplasia | Phase I results showed TA-CIN was well tolerated (10/26) |
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| MISCELLANEOUS | ||||
Advanced | ¿ | Human-based tissue; fibroblast cells grown on a bioabsorbable scaffold | Damaged gum tissue | In a study of more than 20 patients, Advanced Tissue's product demonstrated equivalence to autologous palatal grafts (10/9) |
Amgen Inc. | Aranesp (FDA- | Darbepoetin alfa | Chronic renal | Clinical data from a study in which Aranesp was dosed once every four weeks showed 86% of patients with chronic renal failure receiving dialysis maintained hemoglobin levels within the study target range (10/16) |
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AnorMED | Foznol | Lanthanum carbonate | Hyperphospha- | Phase III results showed Foznol was able to maintain and control blood phosphate levels in patients (10/16) |
Atrix Lab- | Atrisone | Dapsone topical gel in SMP technology | Acne | Company completed enrollment in a Phase III study (10/15) |
Avigen Inc. | Coagulin-B | Gene therapy | Hemophilia B | Company temporarily stopped the Phase I/II trial because trace amounts of the vector were found in the patient's semen (10/8) |
Cellegy | Anogesic | Nitroglycerin ointment | Anal fissures | Phase III results support results of an earlier Phase III in which pain reduction was observed (10/2) |
Cephalon | Provigil (FDA- | Modafinil | Excessive daytime sleepiness | Phase III data showed that Provigil helped keep people awake (10/9) |
D-Pharm | SPD 421 | Phospholipid derivative of valproic acid | Epilepsy | Companies initiated Phase II trials (10/15) |
Dusa Pharma- | Levulan | Photodynamic therapy | Barrett's | Company initiated its second Phase I/II trial (10/10) |
Genaissance | ¿ | Statin response examined by genetic HAP markers | To lower cholesterol | Company initiated its second clinical study designed to link human gene variation to clinical response in order to develop diagnostic and therapeutic products (10/18) |
Human | Repifermin | Systemically administered treatment | Ulcerative colitis | Company completed enrollment in a Phase IIa trial (10/29) |
InKine Pharm- | Visicol (FDA- | Tablet form (formerly | Bowel cleansing prior to colonoscopy | Data from a 98-patient trial showed that Visicol is effective using fewer tablets and a reduced volume of clear liquid (10/23) |
IntraBiotics | Iseganan | Formerly called Protegrin IB-367 Rinse; synthetically derived analogue of naturally occurring protegrins | Cystic fibrosis | Phase I safety data indicate that iseganan can be safely inhaled for up to three days (10/30) |
Isis Pharma- | ISIS 2302 | Antisense inhibitor of intercellular adhesion molecule-1 | Active distal ulcerative colitis | Phase II data demonstrated improved symptoms in patients (10/10) |
Lilly ICOS | Cialis | Oral treatment; a PDE5 inhibitor | Erectile | Phase III data showed that 81% of patients treated with 20 mg of Cialis reported improved erections; absorption was not decreased by food intake (10/2) |
MediGene | Polyphenon E | Cream; anti-inflammatory that blocks virus binding to the cell | Genital warts | In a Phase III trial, the drug had a clearance rate of 61% for men and 57% for women, while placebo showed a 37% clearance (10/24**) |
Modex | EpiDex | Skin replacement product | Skin ulcers | Phase II data showed that 33% of patients displayed complete wound closure after 12 weeks (10/17**) |
Nastech | Somatropin | Recombinant human growth hormone | Growth failure | Company began a Phase I trial to evaluate the nasal administration of somatropin (10/4) |
Neurocrine | NBI-34060 | Type 1 GABA-a, a receptor agonist; chemically distinct from benzodiazepines | Transient | Phase II results showed the drug achieved primary and secondary endpoints (10/1) |
Oculex | Posurdex | Biodegradable microsized drug delivery system designed to provide continuous drug therapy for about one month inside the eye | Persistent macular edema | Company began to enroll patients in its Phase II trial (10/30) |
Ortec Inter- | Orcel (FDA- | Cyropreserved form; bilayered cellular matrix | Venous leg ulcer | A preliminary review of the first 13 patients completing the trial indicated that nine patients achieved 100% wound closure in 12 weeks (10/31) |
Progenics | MNTX | Methylnaltrexone | Debilitating side effects of opioid pain medications | Phase II results showed MNTX significantly reduced the morphine-induced delay in mean oral-cecal transit time to near baseline rates (10/16) |
Proneuron | ¿ | Autologous activated macrophage therapy for nerve regeneration | Spinal cord injury | Company initiated a second Phase I trial (10/22) |
Protein | ¿ | Humanized antibody to interleukin-4 | Asthma | Company started a Phase II trial (10/9) |
SangStat | ABX-CBL | Anti-CD147 monoclonal antibody | Steroid-resistant graft-vs.-host disease | Patients receiving at least four infusions demonstrated a complete or partial response in a Phase II study (10/4) |
Transkary- | Replagal | Enzyme replacement therapy | Fabry's disease | Results from an open-label extension of a six-month pivotal trial showed Replagal was well tolerated, had an excellent safety profile and could have broad therapeutic effects (10/16) |
Unigene | ¿ | Nasal calcitonin spray | Bone loss | Pivotal results showed a rapid and persistent reduction in bone loss as measured by several blood markers (10/9) |
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| Notes: | ||||
| * Privately held; ** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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