Clinical Trial Update: April 2001 |
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Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Abgenix Inc. (ABGX) and Immunex Corp. (IMNX) | ABX-EGF | Monoclonal antibody created with XenoMouse technology directed against the human epidermal growth factor receptor | Kidney cancer | Companies will initiate an 80-patient North American Phase II trial (4/18) |
AnorMED Inc. (Canada; TSE:AOM) and AstraZeneca plc (UK) | ZD0473 | Platinum-based anticancer agent | Ovarian cancer | AstraZeneca initiated a Phase III trial (4/5) |
Biomira Inc. (BIOM) | Theratope | Synthetic carbohydrate-based vaccine; mimic of cancer antigens; alyl-Tn plus carrier molecule KLH | Metastatic breast cancer | Company closed enrollment in its Phase III trial (4/2) |
Cell Genesys Inc. (CEGE) | GVAX | Prostate cancer vaccine used in combination with chemotherapy | Prostate cancer | Company initiated the first in a series of trials to evaluate a highpotency version of GVAX (4/17) |
Gem Pharmaceuticals Inc.* | GPX-100 | Analogue of doxorubicin | Cancer | Phase I/II data showed no signs of cardiotoxicity and the maximum tolerated dose was established (4/4) |
Myriad Genetics Inc. (MYGN) | MPC-7869 | Pure (R-enantiomer) form of flurbiprofen | Cancer | Phase IIa data showed extended daily dosing was well tolerated (4/26) |
Peregrine Pharmaceuticals Inc. (PPHM) | Cotara | Radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out | Soft tissue sarcoma | Company will evaluate the drug in a Phase I trial at Stanford University (4/9); company initiated the trial (4/12) |
Peregrine Pharmaceuticals Inc. (PPHM) | Cotara | Radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out | Liver cancer | Company will evaluate the drug in a Phase I trial used in combination with radiofrequency ablation (4/19) |
Pharmacyclics Inc. (PCYC) | Xcytrin | Injection therapy; motexafin gadolinium | Cancer | Phase Ib/II trial results show the therapy increased local tumor control (4/2) |
Receptron Inc.* | RCN-01303 | Based on hormone receptor technology; it modulates the endogenous thrombopoietin receptor | Cancer chemotherapy-induced platelet deficiency | Company initiated clinical trials (4/2) |
SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymosin alpha/synthetic peptide | Cancer | One-year follow-up data indicated the combination treatment of Zadaxin plus transarterial chemoembolization resulted in statistically significant improvement in survival rates at six, nine and 12 months of 91%, 88% and 78%, respectively (4/23) |
SR Pharma plc (UK; LSE:SPA) | SRL 172 | Immune potentiator | Non-small-cell lung cancer | Phase III data show the drug did not meet its primary endpoint (4/18**) |
Titan Pharmaceuticals Inc. (AMEX:TTP) | Gallium maltolate | Orally active formulation of gallium, a semi-metallic element that inhibits ribonucleotide reductase | Metastatic prostate cancer and refractory multiple melanoma | Company initiated Phase II testing (4/2) |
Titan Pharmaceuticals Inc. (AMEX:TTP) | CeaVac and TriAb | Combination therapy of two monoclonal antibodies | Non-small-cell lung cancer | Company initiated a Phase II study (4/10) |
Valentis Inc. (VLTS) | VLTS-587 | Intravenously administered human interleukin-2 gene medicine | Lung cancer | Company dosed the first four patients in a Phase I trial (4/19) |
Vical Inc. (VICL) | Leuvectin | Gene-based drug injected directly into tumors that uses lipid DNA complex with a gene encoding interleukin-2 to stimulate an immune response | Metastatic kidney cancer | Company discontinued the Phase II trial and plans to start a new one with a higher dose (4/20) |
CARDIOVASCULAR |
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CV Therapeutics Inc. (CVTX) | Ranolazine | Part of pFOX (partial fatty acid oxidation) inhibitors | Chronic angina | Company completed patient enrollment in its Phase III trial (4/10) |
Genentech Inc. (NYSE:DNA) and Actelion Ltd. (Switzerland; SWX:ATLN) | Veletri | Tezosentan; intravenous dual endothelin receptor antagonist | Heart failure | Phase III results showed the drug did not meet its primary endpoint of significantly improving symptoms of dyspnea associated with acute heart failure (4/20) |
Vasogen Inc. (Canada; AMEX:MEW; TSE:VAS) | | Immune modulation therapy | Peripheral vascular disease (PAD) | Company plans to begin a clinical trial enrolling up to 500 patients with moderate to severe PAD (4/26) |
CENTRAL NERVOUS SYSTEM |
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Adolor Corp. (ADLR) | ADL 10-0101 | Agonist of kappa opioid receptor | Pain | Two trials showed positive results of reducing pain and itch (4/6) |
Ceregene Inc. (subsidiary of CellGenesys Inc.; CEGE) | | Gene therapy involving surgical implantation of cells producing nerve growth factor into the brain | Alzheimer's disease | Company treated its first patient in a Phase I study (4/10) |
ConjuChem Inc. (Canada; TSE:CJC) | CJC-1008 | DAC:Opioid drug | Pain | Company completed a Phase I study that found CJC-1008 was better tolerated than Dynorphin A, had a longer half-life than the peptide and showed no unexpected serious side effects (4/10) |
Isis Pharmaceuticals Inc. (ISIP) | ISIS 104838 | Antisense inhibitor of TNF-alpha; intravenous and subcutaneous delivery | Rheumatoid arthritis | Phase I studies demonstrated better dosing schedules than first-generation antisense drugs (4/5) |
NeoTherapeutics Inc. (NEOT) | Neotrofin | Leteprinim potassium | Rheumatoid arthritis | Company opened enrollment for a pivotal Phase III trial of 500 patients at more than 50 U.S. sites (4/10) |
ReGen Therapeutics plc (UK; LSE:RGT) | Colostrinin | Proline-rich polypeptide complex isolated from ovine colostrum | Alzheimer's disease | Company said the steering committee supervising its 90-patient trial recommended the study be continued to its end (4/18**) |
Repligen Corp. (RGEN) | Secretin | Hormone produced by a part of the intestine called the duodenum | Autism | Phase II results showed secretin did not meet its primary endpoint (4/4) |
Scios Inc. (SCIO) | SCIO-469 | Oral p38 kinase inhibitor | Rheumatoid arthritis | Phase Ib data indicated SCIO-469 was well tolerated in healthy volunteers over a two-week dosing period (4/30) |
The Immune Response Corp. (IMNR) | | T-cell receptor peptide vaccine | Multiple sclerosis | Tests showed the vaccine induced a specific response in 80% of patients treated (4/30) |
DIABETES |
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DepoMed Inc. (AMEX:DMI) | Metformin GR | Extended-release, or gastric-retentive, formulation | Type II diabetes | Interim Phase II data indicated the product is statistically similar to its immediate-release counterpart, Glucophage (4/25) |
INFECTION |
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BioChem Pharma Inc. (Canada; BCHE; TSE:BCH) | Zeffix | Lamivudine; nucleoside analogue (oral) | Hepatitis B | Company said data indicated Zeffix induces a complete virologic response in about 23% of children suffering from hepatitis B compared to 13% in the placebo group (4/23) |
Cubist Pharmaceuticals Inc. (CBST) | Cidecin | Daptomycin for injection; a novel cyclic lipopeptide antibiotic derived from a fermentation product of streptomyces roseosporous | Complicated skin and soft tissue infections caused by Gram-positive bacteria | Phase III data showed Cidecin achieved the endpoint of statistical equivalence to the antibiotic standards of care (4/3) |
ICOS Corp. (ICOS) | Pafase | Recombinant human serum protein that inactivates platelet-activating factor | Severe sepsis | Company began enrollment of 2,500 patients in a pivotal Phase III trial (4/27) |
ID Biomedical Corp. (Canada; IDBE; TSE:IDB) | | Subunit intranasal influenza vaccine | Influenza | The vaccine proved safe and well tolerated in a human trial (4/24) |
Inspire Pharmaceuticals Inc. (ISPH) | INS365 | P2Y(2) receptor agonist | Chronic bronchitis | Company temporarily suspended enrollment in a Phase II trial due to difficulty in efficacy assessment (4/24) |
InterMune Pharmaceuticals Inc. (ITMN) | Actimmune | A gamma interferon therapy | Systemic fungal disease | Company completed enrollment in a Phase II trial of 79 patients with cryptococcal meningitis (4/5) |
Maxim Pharmaceuticals Inc. (MAXM) | Ceplene (formerly Maxamine) | Histamine dihydrochloride; an adjuvant to interleukin-2 | Hepatitis C | Company said a multinational clinical study will begin (4/16); company presented Phase II results of Ceplene in combination with interferon-alpha, which showed 40% of evaluable patients sustained a complete viral response (4/20) |
PowderJect Pharmaceuticals plc (UK; LSE:PJP) | | DNA vaccine administered with PowderJect's needle-free system | Hepatitis B | Phase I study indicated the vaccine induced protective levels of antibodies in 80% of volunteers who hadn't responded to three doses of commercial vaccine (4/24) |
Progenics Pharmaceuticals Inc. (PGNX) | PRO 542 | Fusion protein that incorporates HIV binding region of human cell surface receptor (CD4) into a human antibody molecule that binds to GP120 | HIV | Article in The Journal of Infectious Diseases suggests PRO 542 and T-20, which is developed by Trimeris Inc. and Hoffmann-LaRoche Inc., showed significantly enhanced anti-HIV activity when used in combination (4/5) |
Stressgen Biotechnologies Corp. (Canada; TSE:SSB) | HspE7 | Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7 | Genital warts caused by human papillomavirus | Company completed enrollment of its Phase II trial (4/10) |
Stressgen Biotechnologies Corp. (Canada; TSE:SSB) | HspE7 | Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7 | Anal dysplasia caused by human papillomavirus | Phase II data showed 16 of 22 patients were downgraded to low-grade dysplasia (4/24) |
The Immune Response Corp. (IMNR) | Remune | HIV-1 Immunogen used in addition to HAART (highly active antiretroviral therapy) | HIV | Phase III trial data showed that patients treated with Remune showed a reduction in viral load regardless of concomitant antiretroviral drug therapy (4/23) |
Vertex Pharmaceuticals Inc. (VRTX) | GW433908 | HIV protease inhibitor; prodrug of the approved Agenerase (amprenavir) | HIV | Company began a third pivotal Phase III trial, which will compare two doses of the compound in combination with ritonavir and in combination with ritonavir and lopinavir (4/24) |
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MISCELLANEOUS |
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Alkermes Inc. (ALKS) | Medisorb | Injectable therapeutic | Alcohol dependency | Company initiated enrollment in a second trial (4/3) |
Alliance Pharmaceutical Corp. (ALLP) | Oxygent | Intravascular oxygen carrier comprised of liquid perfluorochemical core particles surrounded by a surfactant and suspended in a water-based solution; perflubron emulsion | General surgery | Phase III data showed the average number of units of blood required by the control patients was twice the number required by patients treated with Oxygent (4/9) |
Andrx Corp. (ADRX) | Avicor | Compound diminishes blood levels of beta amyloid protein in patients with hyperlipidemia | Hyperlipidemia | Company completed a Phase II study on the effects of Avicor on metabolism of beta amyloid protein (4/12) |
Atrix Laboratories Inc. (ATRX) | Atrisone | Combination of dapsone and Atrix's drug delivery system, SMP | Moderate to severe acne | Company began patient enrollment in its Phase III trial (4/18) |
Demegen Inc. (OTC BB:DBOT) | P-113 | Peptide-containing mouth rinse | Oral candidiasis | Company will initiate a Phase I/II trial (4/19) |
Discovery Laboratories Inc. (DSCO) | Surfaxin | Humanized, peptide-containing surfactant designed to lower surface tension at the air-water interface in the lungs | Idiopathic respiratory distress syndrome | Company will begin a Phase III trial in premature infants; the trial will enroll 1,500 patients (4/4) |
Human Genome Sciences Inc. (HGSI) | Repifermin | Keratinocyte growth factor-2 (KGF-2) | Chronic venous ulcers | Company began enrolling patients in the Phase IIb trial, which will enroll 700 patients (4/5) |
ICOS Corp. (ICOS) and Eli Lilly & Co. | Cialis | PDE5 inhibitor | Erectile dysfunction | Phase III data showed efficacy among 64% of patients with diabetes-related erectile dysfunction (4/6) |
Inhale Therapeutic Systems Inc. (INHL) and Aventis Behring LLC | | Inhalable form of alpha-1 proteinase inhibitor | Inherited form of emphysema caused by alpha-1 antitrypsin deficiency | Companies completed a Phase Ib trial, which showed all doses tested were well tolerated (4/10) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Protegrin IB-367 Rinse | Synthetically derived analogue of naturally occurring protegrins | Oral mucositis | Phase III results indicate the compound did not meet its primary endpoint of reducing ulceration (4/26) |
La Jolla Pharmaceuticals Co. (LJPC) | LJP 394 | Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus kidney disease | The Central Texas Kidney Association began treating the first 300 patients selected for an international Phase III trial (4/11) |
NexMed Inc. (NEXM) | Femprox | Topical formulation combining NexMed's NexACT penetration drug delivery technology with alprostadil | Sexual arousal disorder | Trial results indicated that Femprox was safe and well tolerated (4/30) |
PhotogenTechnologies Inc. (PHGN) | PH-10 | Topical treatment; photodynamic agent that selectively reduces inflammation of the epidermis and decreases plaque thickness | Psoriasis | Company began a Phase I trial (4/25) |
Sepracor Inc. (SEPR) | Ticalopride | Isomer of propulsid | Heartburn | Trials were suspended due to unspecified adverse events (4/23) |
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Notes: |
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* Privately held |
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** Denotes the date the item ran in BioWorld International. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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NEXT WEEK: Non-U.S. clinical trials and FDA actions in April. |
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