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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Robert K. who wrote (7248)	9/16/1998 8:42:00 PM
From: aknahow	Respond to of 17367

Xoma site now links to abstracts of the 5 / ICAAC presentations, not just description of topic. Sample below: Open Label, Pilot Phase II Trial of Three Dose Levels of Recombinant Bactericidal/ Permeability- Increasing Protein (rBPI-21) Administered by Continuous Intravenous Infusion to Patients with Complicated Intra-Abdominal Infections P.N.R. Heseltine (1), T.V. Berne (1), A. Luterman (2), M.R. Carlson (3), S.S. Kim (3), and M.L. White (3). (1) LAC-University of Southern California Medical Center, Los Angeles, CA, (2) University of South Alabama, Mobile, AL, and (3) XOMA Corporation, Berkeley, CA. Rationale/Design: Bactericidal/permeability-increasing protein (BPI), a 55 kDa protein found in the azurophilic granules of neutrophils, has anti-infective properties that contribute to host defense against bacteria. Recombinant 21-kDa BPI (rBPI-21) has been shown to have anti-bacterial and anti-endotoxin activities similar to naturally-occurring BPI. We report on a phase II open-label pilot study of rBPI-21 as an adjunct to antibiotic therapy in patients with complicated intra-abdominal infections requiring surgical intervention. All patients received at least 3 days of combination antibiotic therapy (ampicillin or vancomycin plus gentamicin, and metronidazole). Within 24 hours of beginning the antibiotic regimen, rBPI-21 was initiated at sequential cohort doses of 0.5, 2.0, or 4.0 mg/kg/day IV x 3 days. Evaluations included clinical response (cure, improvement, or fail) at Days 4 and 30, length of time until fever-free status, oral feeding, clinical cure, and hospital discharge. Results: Of 21 patients entered, 18 were evaluable for efficacy. Diagnoses included perforated appendicitis (12 patients), other perforations (4), liver abcess (1), and intra-abdominal pus (1). The number of days (median) to fever-free was 7.5, 5.0, and 3.0 respectively for each cohort. There were no significant differences in days to oral feeding or hospital discharge. At Day 4, patients assessed as cured or improved by treatment cohort gorup were 75% (6 of 8), 83% (5 of 6), and 100% (4 of 4) respectively. Day 30 results were similar. Lipopolysaccharide bindng protein (LBP) levels obtained for 16 patients were reduced relative to highly-elevated pre-treatment levels, which was consistent with the favorable clinical response. There was a trend for LBP to decrease most rapidly in the high dose group. Only one possibly related adverse event (rash and eye swelling) was observed. Conclusion: Of the rBPI-21 doses administered in this sudy, rBPI-21 at 4.0 mg/kg/day led to the fastest time to improvement in clinical response, fastest time to fever-free status, and greatest reduction in LBP. The anti-infective activities of rBPI-21 may be clinically beneficial in this patient population. (A copy of this poster may be obtained by calling XOMA Investor Relations at (800) BIO-XOMA (246-9662). If your call is answered by voicemail, dial "1" for "Information Request". Please leave your name, mailing address, and the specific poster or posters you wish to receive.) c Copyright 1998, XOMA Corporation

To: Robert K. who wrote (7248)	9/18/1998 1:03:00 PM
From: aknahow	Respond to of 17367

Bob, talk about winning, check out the slgonzalez link to DARPA. Found this by going back to other parts of the site. Looks like XOMA could make a solid proposal. Note the interest in broad based counter measures rather than something that is effective against just a specific threat. web-ext2.darpa.mil "PROGRAM OBJECTIVES AND DESCRIPTION: The most sinister offensive biological warfare scenario employs surprise, immediate proximity, and rapidly lethal, persistent agents in overwhelming quantities. Under these circumstances, real-time sensing, donning of physical protection, and conventional non-medical countermeasures are only marginally effective. An effective operational defense ideally requires instantly available or emplaced countermeasures that can defeat biological threats as they enter the body and before they reach and attack target cells and tissues. The focus of this solicitation is the development of revolutionary, broad spectrum, medical countermeasures against significantly pathogenic micro-organisms and/or their pathogenic products. Protective measures should be able to eliminate biological threats, whether from natural sources or modified through bio-engineering or other manipulation. Protective measures should also have the potential to protect within or on the surfaces of the body and at the most common portals of entry (e.g., inhalation, ingestion, trans-cutaneous). DARPA is not interested in protective measures against single biological threats or single pathogenic products. DARPA seeks proposals that represent the highest potential for revolutionary breakthroughs in biotechnology for this application, while recognizing that such opportunities often carry high risks. Funded research projects will be strongly grounded in scientific and medical principles, yet revolutionary and forward thinking in scope and promise. Specific areas of interest include, but are not limited to: (1) Strategies to broadly defeat a pathogen's ability to a) enter the body b) traverse the bloodstream or lymphatics and c) enter target tissues; (2) Identification of novel pathogen vulnerabilities based upon fundamental, critical molecular mechanisms of survival or pathogenesis (e.g., cellular energetics, virulence modulation); (3) Unique, robust vehicles for the delivery of countermeasures into or within the body; (4) Modulation of the advantageous and/or deleterious aspects of the immune response to significantly pathogenic micro-organisms and/or their pathogenic products in the body; and (5) Decontamination of military personnel and materiel. DARPA is planning to expand its efforts in the development of advanced pathogen countermeasures technology in fiscal years 1999 through 2001. Therefore, we are seeking proposals for 1-3 years of funding. Several parallel research and development projects are likely to be conducted. DARPA anticipates releasing additional BAAs in Unconventional Pathogen Countermeasures as funding is made available. PRE-PROPOSAL: Proposers having the technical and management capabilities, facilities, and experience necessary to conduct all or portions of this program are invited to submit a brief pre-proposal describing their technical approach (including any preliminary data), major technical challenges, participants, principal research topics and milestones, and approximate funding level versus time. Teaming is strongly encouraged, as appropriate, but not a requirement for a successful selection. Submission of a pre-proposal before the proposal is strongly encouraged. DARPA will encourage the bidders with the most promising pre-proposals to submit complete Technical and Cost proposals for full evaluation. This initial screening is intended to save bidders the time and expense of developing a detailed proposal that has little chance for award. DARPA will not provide a de-brief of pre-proposals."