British Biotech plc results for the three months ended October 31, 1994.OXFORD, England--(BUSINESS WIRE)--Nov. 30, 1994-- Highlights o Loss of 6.6 million pounds sterling (US$10.7 million), well within budget. o Cash and short-term investments 58.2 million pounds sterling (US$94.3 million) at the end of the quarter. o Encouraging results from Phase I trial of BB-10010, a new bone marrow protecting drug, and start of Phase I/Phase II trials in cancer patients announced on October 31. o Following the end of the quarter, two drugs, batimastat and lexipafant, commenced Phase III clinical trials. o BB-2516, a potential oral cancer treatment, started Phase I clinical trials in November. o Clinical plans for 1995 announced. Commenting, Dr. Brian Richards, Chairman, said, "Consistent progress has been made in 1994, with both batimastat and lexipafant moving into Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials and BB-10010 and BB-2516 starting clinical trials. The Board looks forward with confidence to 1995, during which important results are expected from all five of British Biotech's clinical programs." OXFORD, England--British Biotech plc Results for the three months ended October 31, 1994 CHAIRMAN'S STATEMENT The second quarter maintained British Biotech's rapid progress in new product development. All three of the company's new cancer treatments advanced further along their respective development paths. In particular, the company's breakthrough oral anti-tumor drug, BB-2516, completed preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. successfully following the end of the quarter, and commenced initial human trials. The injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. drug, batimastat, which is more advanced in development, remains on track for a European Marketing Approval Application early in 1996. Encouraging early clinical data was obtained with the new bone marrow protection agent, BB-10010. Meanwhile, successful Phase II results were announced with the anti-inflammatory drug, lexipafant, in the treatment of pancreatitis and this drug is now in Phase III trials. FINANCIAL The loss, before and after tax, for the second quarter of the 1994/95 financial year was 6.6 million pounds sterling or US$10.7 million, (1993/94: 4.6 million pounds sterling or US$7.5 million), well within the company's internal budget for the period. The increase this year is attributable to the planned rise in operating expenditure related to the progress across the company's development programs. Turnover increased from 693,000 pounds sterling (US$1.1 million) to 858,000 pounds sterling (US$1.4 million). Turnover mainly represents the continuing EUREKA grant funding, further income under the biological research agreement with R&D Systems Europe and income from Glaxo under the collaborative agreement to develop lexipafant for asthma. Operating expenditure both for the quarter and the half-year remains within budget. Net interest increased by 268,000 pounds sterling (US$434,160) in the quarter, reflecting the increased cash balances following the recent Rights Issue. Cash resources (including cash equivalents and short-term investments) decreased by 9.6 million pounds sterling (US$15.6 million) in the period (1993/94: 6.1 million pounds sterling or US$9.9 million). The increase over last year is a result of the increased loss and higher levels of capital expenditure, principally relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the construction of new chemical development facilities in Cowley, Oxford. Cash resources were 58.2 million pounds sterling (US$94.3 million) at the end of the quarter, slightly ahead of budget. RESEARCH AND DEVELOPMENT The quarter saw excellent progress for British Biotech across the company's programs. Of particular note were the positive Phase II results for lexipafant in pancreatitis and encouraging Phase I results for BB-10010, both announced during the quarter. Clinical progress is described in detail below. Metalloproteinase inhibitors Batimastat injectable, the anti-tumor matrix metalloproteinase inhibitor (MMPI MMPI abbr. Minnesota Multiphasic Personality Inventory MMPI Child psychiatry A personality assessment tool widely used in making psychologic evaluations, which is normally given at age 16 and older. Personality testing ), continued to make good progress through clinical development in malignant ascites malignant ascites Excess peritoneal fluid evoked by malignancy, which causes subdiaphragmatic lymphatic obstruction–eg, of the thoracic duct and ↑ intraperitoneal fluid production Etiology Ovarian, breast, gastric, pancreatic, hepatic, colorectal CA, , a distension dis·ten·tion also dis·ten·sion n. The act of distending or the state of being distended. [Middle English distensioun, from Old French, from Latin of the abdomen with tumor fluid which is a feature of some late-stage cancers, and pleural effusion Pleural Effusion Definition Pleural effusion occurs when too much fluid collects in the pleural space (the space between the two layers of the pleura). It is commonly known as "water on the lungs. , a complication of lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. involving fluid accumulation in the chest cavity. In October, recruitment was completed in the UK Phase II trial of batimastat in 40 patients with malignant ascites. The full results of the trial are expected to be announced To be announced (TBA) A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered. at a medical symposium during 1995, but results to date indicate that safety and efficacy were similar to those in the Phase I/II study reported earlier this year. As a result, the company has been able to progress to a Phase III trial which started after the end of the quarter. By the end of October, 16 patients with pleural effusion had been recruited into a Phase I/II study out of a projected total of 21. Preliminary results look encouraging in that batimastat has been well tolerated and appeared to prevent reaccumulation of tumor fluid in the chest in many of the patients in the study. The company plans to start pivotal trials in 1995. BB-2516, the company's second generation MMPI which can be taken by mouth, completed toxicology testing and other preclinical studies successfully and, as a result, a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in healthy volunteers was able to start after the end of the quarter. The commencement of human clinical trials with this new drug is a major milestone for British Biotech's research and development team. The initial volunteer studies are expected to lead to trials in cancer patients during 1995. BB-10010 In October, British Biotech announced the initial results of its Phase I clinical trial with its new bone marrow protecting drug, BB- 10010, and the start of an initial patient safety trial. The Phase I study was conducted in 36 healthy volunteers and showed that BB-10010 was well tolerated at all doses. A clinical trial in patients with various cancers has now begun. The Phase I study also confirmed findings of preclinical studies conducted earlier this year, which showed that BB-10010 mobilizes white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies into the bloodstream. This finding importantly confirmed the bio-activity of the molecule in man and is particularly significant in relation to peripheral bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. (described below). Potential utility of BB-10010 BB-10010 has two potential clinical uses: (i) Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Protection: In this use, the drug may protect blood stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young from damage during cancer chemotherapy. Stem cells are important bone marrow cells which are the precursors of all blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. : damage to stem cells can impair production of white blood cells (which protect against infection), red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells (which carry oxygen) and platelets (which prevent bleeding). If BB-10010 is confirmed to have stem cell protection activity in patients, it may reduce the side-effects of chemotherapy, allowing higher and more effective doses of existing anti-cancer drugs to be given to patients. (ii) Stem Cell Mobilisation: In this use, BB-10010 may mobilize stem cells from their normal location in bone marrow into the bloodstream. This could allow stem cells to be harvested from the bloodstream before chemotherapy and then be replaced after chemotherapy, thus avoiding damage. This process, known as peripheral blood peripheral blood Cardiology Blood circulating in the system/body stem cell transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. , could replace the much more invasive alternative procedure of bone marrow transplantation. The initial patient study which has now commenced is designed to test the safety of BB-10010 in cancer patients. More extensive studies, designed to test efficacy, are scheduled to commence over the next three to six months at both UK and US hospital cancer treatment centers. Lexipafant Lexipafant, the company's PAF PAF platelet activating factor. PAF abbr. platelet-aggregating factor PAF platelet activating factor. antagonist, is being investigated clinically in a number of different diseases. Pancreatitis In September, British Biotech announced results of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of lexipafant in patients with acute pancreatitis acute pancreatitis Inflammation of the pancreas of abrupt onset, often with gallstones and alcohol ingestion Epidemiology 109,000 hospitalizations, 2251 deaths–US; 10-fold ↑ from 1960s to 1980s–reason unclear; , at a meeting of The European Pancreatic Club in Bologna, Italy. The Phase II efficacy trial was conducted in 83 patients with pancreatitis, by five participating UK hospitals co-ordinated by the Royal Liverpool University Hospital The Royal Liverpool University Hospital is a large teaching hospital in Liverpool, England. It is part of the Royal Liverpool and Broadgreen University Hospital NHS Trust and is associated with the University of Liverpool. . Pancreatitis is a serious inflammatory disease of the pancreas resulting in severe abdominal pain which usually requires hospitalization for treatment. Patients treated with lexipafant, when compared to those receiving placebo, showed a consistent trend towards a more rapid: o improvement in clinical severity; and o reduction in systemic and pancreatic inflammation, as measured by the levels in blood of three different surrogate markers of inflammation, interleukin-8, interleukin-6 and E-selectin. Changes in the blood concentrations of inflammatory markers are known to correlate with disease severity in pancreatitis and, in particular, interleukin-6 has been shown to be predictive of clinical outcome. It is therefore noteworthy that, in this trial, lexipafant reversed the characteristic rise in interleukin-6 in the early stage of the disease. By 24 hours after commencement of therapy, significant differences between lexipafant and placebo groups were apparent in blood concentrations of both interleukin-6 and interleukin-8. As a consequence of these encouraging Phase II results, lexipafant commenced a Phase III pivotal trial in pancreatitis after the end of the quarter, intended to confirm clinical benefit in the treatment of this serious acute disease. If successful, this Phase III trial in 300 patients may form the basis of a European Marketing Approval Application. Sepsis Lexipafant is also being evaluated in a number of other acute care conditions, including sepsis and coronary artery bypass grafting coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. . Preliminary information is now available from a double-blind, 150- patient Phase II trial of lexipafant in severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status , which indicates that lexipafant is unlikely to be of clinical benefit in the treatment of sepsis. Although the drug was well tolerated and organ function appeared to be improved partially by treatment, mortality was not significantly different in treatment and placebo groups. As a consequence of these results, the company has decided not to pursue further trials of lexipafant in this indication. p24-VLP p24-VLP is being studied in two different formulations, adjuvanted and unadjuvanted. Adjuvanted p24-VLP, the AIDS immunotherapeutic, continued to recruit well in the Phase II studies, with almost 500 patients enrolled into four separate studies. Patient recruitment is complete in three studies and one study is still recruiting, a combination study with AZT AZT or zidovudine (zīdō`vy  dēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called in Australia. The first results should be known in the second half of
1995.Unadjuvanted p24-VLP: The Phase I trial results were presented at a symposium in the USA after the end of the quarter. The trial, which was designed to test whether this form of p24-VLP could induce cytotoxic T lymphocyte cytotoxic T lymphocyte CTL, cytotoxic T cell Immunology A subset of T cells with a CD8 receptor on the surface that recognizes and lyses malignant or virally-infected self cells bearing self, ie 'haplotype restricted', class I MHC molecules. (CTL See control key. 1. CTL - Checkout Test language. 2. CTL - Compiler Target Language. 3. CTL - Computational Tree Logic ) responses in humans, showed that p24- VLP VLP Virus-like particles, see there without adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. can induce a CTL response, but only at a low level and for a short period. The company has therefore decided that it will not pursue further trials with unadjuvanted p24-VLP. BRITISH BIOTECH INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. During the quarter, the company announced two key management appointments in the USA. Dr. Gregory M. Hockel, PhD, joined as Vice President, Regulatory Affairs. Dr. Hockel will oversee British Biotech's regulatory submissions in the United States including all Investigational New Drug (INDs) submissions and New Drug Applications (NDAs). Dr. Henrick S. Rasmussen, MD PhD, has joined as Vice President of Clinical Research and will be responsible for British Biotech's clinical research program in the United States. Dr. Rasmussen has had responsibility in other companies for directing clinical studies in Europe, USA, Japan and Australia/New Zealand, regularly meeting US investigators and experts as well as the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . PLANS FOR 1995 1995 promises to be a pivotal year for British Biotech. All five of the company's leading products will complete significant clinical trials. While it is difficult to be precise about timing and results, outline plans are as follows: Metalloproteinase inhibitors Batimastat - malignant ascites The European Phase III study program currently comprises two separate multi-centre clinical trials in patients with malignant ascites. Each trial will enrol 150 patients and will take approximately one year to complete. The first trial has now started and is being conducted at approximately 20 hospitals in the UK. The second trial will commence in early 1995 and will be conducted at approximately 20 hospitals in Germany Here is a list of hospitals in Germany.
Batimastat - pleural effusion Full results of the current Phase I/II studies are expected to be released in the second quarter of 1995 at a major US oncology conference. Pivotal trials in Europe are expected to start in the first half of 1995. A parallel clinical program is being planned in the USA. BB-2516 If the current Phase I trials show BB-2516 to be well tolerated and absorbed, Phase II studies should commence around the middle of 1995. Initially, the company is planning to test BB-2516 in four different solid tumor types, with parallel programmes in the UK and the USA. BB-10010 Following the successful Phase I trial described above, a further volunteer study will shortly commence in which the ability of the drug to mobilize bone marrow cells will be measured. A series of clinical trials in cancer patients is the next step in developing this compound. Patients will be studied during receipt of cancer chemotherapy in order to demonstrate protection of bone marrow cells by BB-10010. One of these studies is planned for the USA and an IND application has been submitted to FDA to obtain authorisation for this clinical trial. END OF PART 1 OF 2 MORE TO FOLLOW.... CONTACT: British Biotech plc, 011 44 865 748747
James Noble, Finance Director
Katie Arber, Public Relations Manager
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British Biotech Inc., 410-266-7909
Dr. Peter McCann, President
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G.A. Kraut Company, 212-696-5600
Gerard Coffey, Vice President
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