| Company** | Product | Description | Indication | Type Action (Date) |
| CANCER | ||||
| Biomira Inc. | Tru-Scint AD | Technetium-99m- | In vivo imaging agent | Canadian regulatory |
| (Canada) | labeled monoclonal | for detecting recurrent | agency informed com- | |
| antibody that reacts | breast cancer and pri- | pany that the data in its | ||
| with most adeno- | mary residual or recur- | new drug application (NDA) | ||
| carcinomas | rent ovarian cancer | (filed 5/96, seeking expe- | ||
| dited approval) were insuf- | ||||
| ficient for determining sta- | ||||
| tistical significance; com- | ||||
| pany will not resubmit NDA | ||||
| (12/1) | ||||
| Cel-Sci Corp. | Multikine | Natural mixture of | Head and neck cancer | Expanded clinical trials |
| human cytokines, | treatment prior to sur- | in Canada (12/3) | ||
| including interleukin-2 | gery or radiation therapy | |||
| Immuno-Designed | MAK Cell | Macrophage-activated | Single therapy (or com- | Initiated Phase II trials in |
| Molecules SA* | Therapy | killer cell therapy (uses | bination therapy with | France (12/10) |
| (France) | point-of-care cell | bispecific antibodies) for | ||
| processor to isolate | ovarian and bladder | |||
| mononuclear cells from | cancer | |||
| patient's blood; cells | ||||
| activated ex vivo) | ||||
| Novopharm | NOVOMAb- | Recombinant, pan- | Progressive non-Hodg- | Initiated Phase I trial in |
| Biotech Inc. | G2 scFv | carcinoma-specific | kin's B cell lymphoma | Canada (12/17) |
| (TSE:NVO; Canada) | human monoclonal | |||
| antibody | ||||
| (2nd generation) | ||||
| Maxim | Maxamine | H2 receptor agonist that | Combination therapy | Results of ongoing clini- |
| Pharmaceuticals | blocks phagocyte signal | with interleukin-2 for | cal trial (being conducted | |
| Inc. | that leads to death of | improving relapse- | in Sweden) published in | |
| natural killer T cells | remission in acute | 12/97 issue of Leukemia | ||
| myelogenous leukemia | and Lymphoma (12/2) | |||
| CARDIOVASCULAR | ||||
| BioTime Inc. | Hextend | Blood plasma volume | Replacement of blood | Completed Phase III |
| expander | volume during surgery | trials in U.K. (12/8) | ||
| in which substantial | ||||
| amounts of blood are lost | ||||
| Hemosol Inc. | Hemolink | Highly purified hemo- | For use in orthopedic | Expanded sites for Phase |
| (TSE:HML; Canada) | globin extracted from | surgery (primary hip and | II Canadian trials to in- | |
| outdated human donor | primary knee replace- | clude the Maritimes | ||
| blood, then cross-linked | ments) | (12/22) | ||
| to form stable hemo- | ||||
| globin molecule (red | ||||
| blood cell substitute) | ||||
| Hemosol Inc. | Hemolink | Highly purified hemo- | To enhance effective- | Canadian health author- |
| (TSE:HML; Canada) | globin extracted from | ness of erythropoietin | ities approved protocol | |
| outdated human donor | therapy in patients | for additional Phase II | ||
| blood, then cross-linked | with chronic anemia | trial (12/18) | ||
| to form stable hemo- | associated with kidney | |||
| globin molecule (red | failure | |||
| blood cell substitute) | ||||
| CENTRAL NERVOUS SYSTEM | ||||
| Chiroscience | Chirocaine | Levobupivacaine; chiral | Broad usage in local, | Submitted European mar- |
| Group plc (U.K.) | version of approved drug | regional or spinal | keting authorization | |
| bupivacaine | anesthesia | application (in Sweden) | ||
| (12/4) | ||||
| DIABETES | ||||
| Cortecs | Macrulin | Oral capsule formulation | Type II diabetes | Reported data from Phase |
| International Ltd. | of porcine insulin (insulin | II trial on 6 patients in | ||
| (U.K.) | peptide coated with an | the Netherlands (12/10) | ||
| amphipathic molecule) | ||||
| Scotia Holdings plc | Tarabetic | Gamma-linolenic acid | Diabetic neuropathy | U.K.'s Medicines Control |
| (Scotland) | (based on evening | Agency rejected marketing | ||
| primrose oil) | application (for the 2nd | |||
| time) based on wide var- | ||||
| iation in results from 12 | ||||
| clinical trial centers; | ||||
| company will not conduct | ||||
| more trials (12/19) | ||||
| INFECTION | ||||
| Aquila | Malaria | Vaccine containing the | Malaria | Initiated Phase I trial in |
| Biopharmaceuticals | vaccine | synthetic peptide SPf66 | Colombia (cosponsored | |
| Inc. | (hybrid molecule contain- | by the Colombian govern- | ||
| ing antigenic domains | ment and the World | |||
| from 2 life cycle stages | Health Organization) (12/1) | |||
| of malaria parasite), plus | ||||
| the Stimulon adjuvant | ||||
| QS-21 | ||||
| Aronex Pharma- | Nyotran | Liposomal formulation | Systemic fungal | Filed marketing author- |
| ceuticals Inc. and | of the antifungal agent | infections | ization application | |
| Grupo Ferrer Inter- | Nystatin | in Spain (12/19) | ||
| nacional SA (Spain) | ||||
| Aviron and Smith- | -- | Vaccine based on | Vaccine for infectious | Initiated Phase I trial in |
| Kline Beecham | single surface antigen | mononucleosis (caused | Belgium (12/3) | |
| Biologicals | responsible for most of | by EBV) | ||
| (Belgium; unit of | the neutralizing antibodies | |||
| SmithKline Beecham plc; | stimulated by Epstein- | |||
| NYSE:SBH; U.K.) | Barr virus (EBV) infection, | |||
| together with SmithKline's | ||||
| adjuvant technology | ||||
| The Liposome | Abelcet | Amphotericin B lipid | Severe, invasive fungal | Approved for marketing |
| Co. Inc. | complex (injection) | infections (2nd-line | in Norway (12/29) | |
| therapy) | ||||
| Novopharm | GPI-2A | Antisense therapy; | HIV infection and | Initiated Phase I trial in |
| Biotech Inc. | use of antisense oligo- | AIDS | Canada (12/9) | |
| (TSE:NVO; Canada) | nucleotide that blocks | |||
| HIV replication, | ||||
| delivered via cationic | ||||
| liposomes | ||||
| Synsorb Biotech | Synsorb Pk | Orally delivered carbo- | Prevention of serious | Received approval to |
| Inc. (Canada) | hydrate attached to inert, | complications from | begin Phase III trials in | |
| insoluble support; binds | E. coli infections, | Argentina (12/2) | ||
| to toxins secreted by | including hemolytic | |||
| bacteria in the gastro- | uremic syndrome | |||
| intestinal tract | ||||
| MISCELLANEOUS | ||||
| Aeterna | Psovascar | Shark cartilage extract | Moderate-to-severe | Health Canada approved |
| Laboratories Inc. | with anti-angiogenic | psoriasis | protocol for Phase I/II | |
| (TSE:AEL; Canada) | and anti-inflammatory | trial (12/17) | ||
| properties | ||||
| Biomatrix Inc. | Hylaform | Hylan B gel tissue | Correction of facial | Approved for marketing |
| augmentation product | wrinkles and depressed | in Canada and Israel | ||
| scars | (12/31) | |||
| Hyal Pharma- | Hyanalgese-D | Diclofenac 3% gel | Pain relief in osteo- | Announced that product |
| ceutical Corp. | (formulated in drug | arthritis | did not achieve statistic- | |
| (TSE:HPC; Canada) | delivery system) | ally significant results in | ||
| Phase III Canadian trial; | ||||
| company will discontinue | ||||
| product development | ||||
| (12/17) | ||||
| Integra | Integra | Product consists of | Wound healing in burns; | Approved for marketing |
| LifeSciences Corp. | Artificial Skin | bovine tendon-derived | also, use in plastic and | in People's Republic of |
| implantable matrix with | reconstructive surgery | China (12/8) | ||
| an outer layer of a | ||||
| silicone-based substitute | ||||
| for epidermis | ||||
| Life Medical | Piliel | Serum-free combina- | Topical gel for hair | Company terminated the |
| Sciences Inc. | tion of nutrients and | regrowth and reduction | European clinical trials on | |
| (NASDAQ:CHAI) | hormones applied in | of hair loss in men | this product, saying it had | |
| situ; thought to stimulate | sufficient information that | |||
| cell growth, form blood | the product would not | |||
| vessels and improve | yield the desired benefit | |||
| blood flow | (12/17) | |||
| NPS Pharma- | KRN-568 | Orally active small | Primary | Kirin initiated Phase II |
| ceuticals Inc. and | (R-568) | molecule drug that acts | hyperparathyroidism | trial in Japan (12/11) |
| Kirin Pharma- | at calcium receptors on | |||
| ceuticals (division of | surface of parathyroid | |||
| Kirin Brewery; Japan) | cells | |||
| Oxford | OGT 918 | Orally active small | Gaucher's disease | U.K.'s Medicines Control |
| GlycoSciences plc* | molecule that inhibits | (lysosomal storage | Agency approved clinical | |
| (U.K.) | glycolipid formation | disease) | trial protocol (12/31) | |
| SangStat Medical | Bulk cyclo- | Ingredient in SangStat's | Immunosuppressive | Approved for manufactur- |
| Corp. and Gensia | sporine | cyclosporine generic | drug; used to prevent | ing in European Union |
| Sicor Inc. | substance | drug | graft rejection in | (12/11) |
| organ transplantation | ||||
| NOTES: | ||||
| This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms. It covers only those events that were announced in 12/97. It does not cover ongoing clinical trials for which no news was issued that month. | ||||
| TSE = Toronto Stock Exchange | ||||
| * Private companies are indicated with an asterisk. | ||||
| ** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 10-11. | ||||