Company* | Product | Description | Indication | Status (Date) |
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CANCER |
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AltaRex Corp. | OvaRex | Oregovomab; a fully foreign monoclonal antibody that targets CA125 | Mestastatic ovarian cancer | Company reported statistically significant and consistent results from its ongoing analysis of its OvaRex Phase IIb trial (2/7) |
Aphton Corp. | G17DT | Anti-G17 immunogen | Gastric cancer | Phase II results showed no reported side effects when used in combination with chemotherapy; of 30 patients treated, half had a partial tumor response (2/11) |
Biomira Inc. | Theratope | Vaccine; synthetic carbohydrate-based; mimic of cancer antigen sialyl-Tn plus carrier molecule KLH | Metastatic colorectal cancer | Company initiated a pilot Phase II trial (2/6) |
Cell Therapeutics | CT-2106 | PG-CPT (polyglutamate camptothecin) | Cancer | Company was cleared to begin Phase I trials (2/5) |
Cytogen Corp. | Quadramet | Samarium-153 EDTMP (intravenous radio- pharmaceutical) | Osteosarcoma | Study results showed 24 of 30 patients undergoing treatment experienced good to excellent results in delaying local progression of the cancer (2/21) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Acute myeloid leukemia and small-cell lung cancer | Company began two multicenter trials in previously untreated patients (2/11) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Non-Hodgkin's lymphoma | Company began a trial testing Genasense in combination with Rituxan plus standard chemotherapy (2/19) |
Immunomedics | - | I-131-labeled humanized CEA antibody | Colorectal cancer | Phase II results showed that out 19 patients, three experienced a partial remission and eight showed minor responses; also, out of nine patients who had their metastases resected prior to therapy, 78% remained free of the disease for up to 36 months (2/28) |
Inex Pharma- | Onco TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Relapsed Hodgkin's disease | Company expanded clinical development to include a new Phase II trial (2/12) |
InterMune Inc. | Actimmune | Interferon gamma-1b injection | Ovarian cancer | Company began enrolling patients in a Phase III trial (2/5) |
Ligand Pharma- | Targretin | Gel (bexarotene gel 1%); synthetic retinoid analogue that selectively activates retinoid X receptors | Cutaneous T-cell lymphoma | Clinical results showed more than 85% of patients who were treated at least one year responded to treatment; the gel was generally well tolerated; adverse events included skin irritation, itching, redness, burning and pain (2/28) |
Pharmacia Corp. (NYSE:PHA) | SU5416 | A synthetic small-molecule inhibitor that blocks the vascular endothelial growth factor | Colorectal cancer | Company decided to end its program based on Phase III results that indicate the product would not meet its endpoints (2/8) |
PhotoCure ASA | Metvix | Photodynamic therapy | Basal cell carcinoma | Phase III results indicated there were no significant differences between disease recurrence rates in patients treated with Metvix and with cryotherapy (2/12) |
Titan Pharma- | CeaVac | Monoclonal antibodies; induces an immune response to the carcino-embryonic antigen | Dukes' D colorectal cancer in patients with resected liver metastases | Titan initiated a Phase II study to evaluate combination therapy of CeaVac and TriAb (2/7) |
Vion Pharma- | Tapet-CD | Armed vector; a weakened Salmonella typhimurium bacteria engineered to produce the enzyme cytosine deaminase | Advanced or metastatic solid tumors | Company began a Phase I trial (2/4) |
CARDIOVASCULAR |
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Actelion Ltd. | Tracleer | Bosentan tablets | Chronic heart failure | Tracleer failed to meet primary endpoints in a Phase III trial (2/7) |
Avant Immuno- | TP10 | Complement inhibitor | High-risk cardiac surgery | Company decided to drop TP10 following the Phase II failure in which it did not meet its primary endpoint (2/20) |
Collateral | Generx (Ad5-FGF4) | Nonsurgical angiogenic gene therapy | Stable angina | Phase I/II results showed the drug was safe and well tolerated with no immediate adverse effects (2/26) |
Myogen Inc.* | Enoximone | Phosphodiesterase (type III) inhibitor; oral formulation | Heart failure | Company began a second pivotal Phase III trial with 1,400 patients (2/6) |
Texas Bio- | Argatroban | A direct thrombin inhibitor anticoagulant | Acute ischemic stroke | An analysis suggested positive clinical effects of Argatroban in acute ischemic stroke in patients with heparin-induced thrombocytopenia (2/8) |
Vasogen Inc. | - | Immune modulation therapy; involves the stressing of a small sample of a patient's blood using a medical device, followed by the administration of the stressed cells back to the patient | Chronic congestive heart failure | Phase II results of 73 patients showed drug group experienced significant improvements as measured by hospitalizations and deaths; company plans to move into a Phase III trial (2/28) |
CENTRAL NERVOUS SYSTEM | ||||
Angiotech | Paxceed | Systemic formulation of micellar paclitaxel | Multiple sclerosis | Phase II results showed the product did not meet its primary endpoint; the company does not expect to move forward with a Phase III trial (2/25) |
BioMS Medical | MBP8298 | Intravenously injected peptide technology | Chronic, progressive multiple sclerosis | Phase II results indicate a high percentage of patients had complete or partial anti-MBP suppression, and also showed some clinical stabilization and no side effects (2/18) |
Teva Pharma- | Copaxone | Oral formulation of glatirameracetate | Relapsing- | Company said the trial failed due to a strong placebo effect; Copaxone did not achieve a statistically significant effect on relapse rate (2/21) |
The Immune Response Corp. (IMNR) | NeuroVax | Intramuscular injection of peptides | Multiple sclerosis | Phase I/II results confirmed the primary endpoint had been met; the group receiving NeuroVax demonstrated a statistically significant response as compared to placebo (2/27) |
INFECTION | ||||
Acambis plc | Chimeri- | Vaccine technology; inactivated, purified, whole virus recognizable to the immune system as JE virus | Japanese encephalitis | Company said Phase II results were positive, showing the vaccine was well tolerated at all doses with 98% of subjects developing antibodies within one month; the trial was conducted in the U.S. (2/20**) |
AnorMED | AMD- | Inhibitor of CXCR4, a chemokine receptor | HIV | Clinical results demonstrate that AMD-3100 completely eliminated a specific strain of HIV in nine of 19 patients and that the activity is dose dependent (2/26) |
Gilead | Viread | Tenofovir disoproxil fumarate; nucleotide analogue reverse transcriptase inhibitor | HIV | Phase III results showed that highly treatment-experienced HIV-infected patients who received Viread 300 mg in addition to existing antiretrovirals achieved a significant HIV RNA reduction, durable through 48 weeks (2/25); company also found a reduction in serum HBV DNA levels compared to placebo in patients who also were infected with hepatitis B virus (2/27) |
The Immune Response Corp. (IMNR) | Remune | HIV-1 immunogen | HIV | Clinical results showed a statistically significant increase in CD8+ memory T cells in the Remune group compared to the Incomplete Freund's Adjuvant control group (2/28) |
Trimeris Inc. | T-20 | Fusion inhibitor | HIV | Phase II results indicated that T-20 contributes to the suppression of plasma viral load and was well tolerated over the course of nearly a year as part of antiretroviral combination therapy (2/19) |
INFLAMMATION AND PAIN | ||||
AtheroGenics | AGIX-4207 | Oral compound derived from the v-protectant technology platform | Rheumatoid arthritis | Company completed a Phase I trial demonstrating the safety of AGIX-4207 (2/20) |
Omeros Medical | OMS-103HP | Drug that blocks inflammation and pain throughout the arthroscopic procedure; delivered directly to the joint, at the actual site of injury | Post-operative pain reduction | Company said the drug provided statistically significant improvement in post-operative pain reduction, joint motion and recovery of function (2/27) |
Scios Inc. (SCIO) | SCIO-469 | Oral p38 kinase | Rheumatoid arthritis | Company began enrollment for a Phase IIa trial (2/27) |
MISCELLANEOUS | ||||
Adolor Corp. | Alvimopan | Small-molecule opioid receptor antagonist | Post-operative ileus | Company began enrollment in two Phase III trials (2/6) |
Alexion Pharmaceuticals Inc. (ALXN) | 5G1.1 | Anti-inflammatory C5 inhibitor antibody | Membranous nephritis | Company completed enrollment in a Phase II trial (2/20) |
Avigen Inc. | Coagulin-B | Adeno-associated virus gene therapy vector containing the Factor IX gene | Hemophilia B | Company is proceeding with its liver delivery clinical trial as it was found safe and well tolerated with confirmation of successful gene transfer and protein expression in all patients treated (2/4) |
Biogen Inc. | Amevive | Alefacept; novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells | Psoriasis | Phase III data indicated the product was safe, efficacious and approvable (2/25) |
Bio-Technology General Corp. (BTGC) | Puricase | A polyethylene glycol conjugate of uricase (urate oxidase) | Severe gout | Company began a Phase I study (2/4) |
Cerus Corp. | Intercept | Red Blood Cell System; pathogen inactivation system | Chronic transfusion support | Companies can proceed with their second pivotal Phase III trial, which will enroll about 50 patients (2/21) |
Cypress Bioscience Inc. (CYPB) | Milnacipran | The first of a new class of agents known as NSRI's, or Norepinephrine Serotonin Reuptake Inhibitors | Fibromyalgia syndrome | Company launched its Phase II program (2/25) |
Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA) | Xanelim | Efalizumab | Psoriasis | Phase III results suggest that some patients may experience longer periods of benefit when treated for 24 weeks (2/25) |
Immunex | Enbrel | Tumor necrosis factor inhibitor | Psoriasis | Phase II results showed that 56% of patients treated with Enbrel had at least a 75% improvement over a six-month period, compared to 5% of patients receiving placebo (2/22) |
InKine Pharma- | Visicol (FDA- approved) | Tablet form (formerly Diacol); sodium phosphate | Bowel cleansing prior to colonoscopy | Clinical results showed Visicol is effective using fewer tablets and a reduced volume of clear liquid (2/5) |
Isis Pharma- | ISIS 2302 | Intercellular adhesion molecule-1 inhibitor; alicaforsen | Psoriasis | Phase II data showed ISIS 2302 missed its primary endpoint (2/25) |
NicOx SA | NCX 1015 | Nitric oxide-releasing derivative of prednisolone | Inflammatory bowel disease | Company reported positive clinical results of a 32-patient Phase I study (2/14) |
Ortec Interna- | OrCel | A collagen sponge seeded with alogeneic epidermal and dermal cells | Venous ulcers | Results of a six-month follow-up of 36 patients showed that 71% of those treated with a non-frozen version of OrCell achieved 100% wound closure (2/5) |
Palatin Tech- | PT-141 | Peptide analog of (alpha)-MSH ([alpha]-melanocyte- stimulating hormone) | Male and female sexual dysfunction | Phase I results were positive (2/19) |
Progenics Pharmaceuticals Inc. (PGNX) | MNTX | Methylnaltrexone; designed to reverse the side effects of opioids without interfering with pain relief | Narcotic-induced constipation | Company initiated a Phase IIb trial (2/22) |
Repligen Corp. (RGEN) | Secretin | Human synthetic secretin | Autism | Company began Phase III trials of secretin in the treatment of autism in children (2/15) |
Scil Biomedicals GmbH (Germany)* | - | Smart (humanized) Anti-L-Selectin Antibody | Trauma | Company said enrollment in its Phase II trial in trauma patients is completed (2/7) |
Synaptic Pharmaceutical Corp. (SNAP) | SNEC-2 | Targets SCT-11, a G protein-coupled receptor | Depression | Company began a Phase I trial (2/5) |
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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; CDNX = Canadian Venture Exchange; NYSE = New York Stock Exchange; OSE = Oslo Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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