Biotechnology news highlights from the 38th Annual AmericanSociety of Hematology (ASH) Conference, in Orlando, this weekinclude:
* Alexion Pharmaceuticals Inc., of New Haven, Conn., reportedpositive Phase I results with its C5 inhibitor. The study was designedto assess safety, pharmacokinetic and biological activity in a healthypopulation. The single-blind, placebo-controlled, ascending-dosestudy of the drug involving 33 healthy male volunteers indicates thata single dose of 5G1.1-SC, administered intravenously at doses up to2 mg/kg was safe and well tolerated. It was further reported that asingle administration of 5G1.1-SC at the highest dose providedsignificant inhibition of complement dependent hemolytic activity forgreater than 12 hours. Further, the study showed that sustainedsystemic inhibition of the complement cascade was achieved in adose-dependent manner.
* Celltech Group plc, of Slough, U.K., reported encouraging resultswith the novel drug CMA 676 in acute myeloid leukemia. The drugwas administered to 36 refractory AML patients in two U.S. centersin an ascending dose study. These patients had previously failedseveral existing treatments. In the higher dose range, two patientsshowed a complete response to treatment with all leukemic cellseliminated from the blood and bone marrow and restoration of anormal blood cell count. Three partial responses were achieved, withcomplete disappearance of leukemic cells, but without regaining anormal blood count.
* Ligand Pharmaceuticals Inc., of San Diego, reported that interimresults of Phase I/II clinical trials for the treatment of mycosisfungoides (cutaneous T-cell lymphoma) with Targretin Topical Gel,proved the product to be generally well tolerated, despite someaccompanying retinoid erythema and irritation. A response totreatment of at least four weeks duration was achieved in 11 out of 27evaluable patients at the time of the assessment. One patient hadcomplete clearing and 10 patients had partial response (greater thanor equal to 50 percent), four cleared by greater than or equal to 90percent. In the assessment of ongoing study, 18 patients had at leastmild improvement (greater than or equal to 25 percent).
* Medarex Inc., of Annandale, N.J., said that its MDX-22 leukemiaproduct continues to promote long-term, disease-free survival inpatients suffering from acute myeloid leukemia. Phase II clinicaltrials reported on 138 patients who have undergone transplants withtheir own bone marrow treated with MDX-22. Patients in a variety ofdiseased stages were treated and the results, the company said, werepromising in all groups. Patients who underwent transplants duringsecond or third complete studies indicate that 36 percent of patients,who underwent a preparatory regimen with busulfan andcyclophosphamide followed by a transplant with MDX-22-treatedmarrow, experienced two years of disease-free survival. All patients,but one, are still disease-free, with some patients living as long at 10years.
* Sequus Pharmaceuticals Inc., of Menlo Park, Calif., presented datathat indicated Amphotec, in combination with surgical debridement,is effective therapy for patients with zygomycosis, a life-threateningfungal infection. Twenty two of 572 patients treated with Amphotecin Phase II clinical trials were identified as having zygomycosis. Themajority of these patients were either amphotericin B failures or hadcontraindications to the use of conventional amphotericin B. Eighteenof the 22 patients were considered evaluable. Thirteen of the 18patients underwent surgical debridement concomitant withAmphotech therapy, while the other five patients received Amphotectherapy only. Twelve of the 18 patients responded to Amphotectherapy ( eight complete responses, four partial responses) and sixfailed therapy. Seven of the 13 patients who received Amphotec andunderwent surgery responded completely and were cured. Of thepatients who received medication only, four of five responded, butthe complete response rate dropped to one of five patients.
* SyStemix Inc., of Palo Alto, Calif., said the company'shematopoietic stem cell transplants have been shown to engraft inless than two weeks in patients undergoing either myelosuppressiveor myeloablative therapy for cancer. Results from seven patients inthe company's European Phase I/II clinical trial to support multiplemyeloma patients undergoing high dose chemoradiotherapy showedthe median time to successful engraftment (recovery) of neutrophils(white blood cells) was 11 days and was 13 days for plateletindependence.
* Xenova Group plc, of Berkshire, U.K., reports a novel mechanismof action for its new class of thrombosis drugs, which were originallyidentified in a microorganism. These drugs appear to accelerate theclearance of blood clots by preventing the inhibition of tissueplasminogen activator by the regulatory protein plasminogenactivator inhibitor.
(c) 1997 American Health Consultants. All rights reserved.