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Biotech / Medical : ARADIGM CORP. ARDM -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (137)	9/3/2002 10:08:13 AM
From: tuck	Respond to of 255

>>Tuesday September 3, 7:19 am ET BAGSVAERD, Denmark and HAYWARD, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Novo Nordisk (NYSE: NVO - News) and Aradigm Corporation (Nasdaq: ARDM - News) today announced the initiation of the Phase 3 clinical program for NN1998 -- the AERx® insulin Diabetes Management System (iDMS). The first Phase 3 study, in people with type 1 diabetes, is designed to show that the long-term safety and efficacy profile of inhaled human insulin is comparable to that of subcutaneous injections. "We are pleased that the Phase 3 studies are now underway to help us make this innovative treatment available to the patients," said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk. This 24-month study is a multi-center, open-label study with patients receiving either inhaled insulin via the AERx® system or subcutaneous injections of NovoRapid® (NovoLog® in the US) three times daily before meals. Additionally, both groups are receiving basal insulin once or twice daily. "With this important milestone for Aradigm, we are one step closer to bringing a significant alternative to insulin injections to patients with diabetes," said Richard Thompson, President and Chief Executive Officer of Aradigm. "Encouraging data from our earlier studies have enabled us to design a robust Phase 3 program." In addition to investigating long-term pulmonary safety, the study will also look at the incidence of hypoglycaemic events, insulin antibody formation, glycaemic control (blood glucose profiles) and overall treatment satisfaction. In recent meetings with regulatory authorities a plan to demonstrate safety and efficacy in people with both type 1 and type 2 diabetes was agreed. Since type 1 patients are more sensitive to minor health and life events such as illness, changes in exercise regimen, or travel, significant attention is paid to meeting the greater requirements of these people. About NN1998 - AERx® iDMS The AERx® electronic platform guides users to inhale correctly and automatically deliver the drug at the right time in the breath (Breath-Check System). Based on a proprietary liquid formulation and the AERx® iDMS Strip(TM), the system converts the liquid insulin formulation into fine aerosolised particles to be delivered locally to the deep lung and thereby to the systemic circulation. In June 2002, at the Annual Meeting of the American Diabetes Association, the two companies Novo Nordisk and Aradigm, announced clinical results from a Proof-of-Concept study in people with type 2 diabetes, which showed comparable glycaemic control between patients using the AERx® system and those using an intensive regimen of mealtime insulin injections. In addition, results from the 12-week study showed a favourable safety profile for the AERx® system including no difference between the two groups in FEV1, a lung function parameter. The number of hypoglycaemic events was 151 in the AERx® group compared to 211 in the comparator group. Clinical safety and efficacy data on the AERx® iDMS system was presented at the 38th European Association for the Study of Diabetes (EASD) annual meeting on 2 September 2002 in Budapest, Hungary. The press release containing these data, and other press releases distributed by Novo Nordisk at the EASD, can be found at www.novonordisk.com . All abstracts presented by Novo Nordisk at the conference can also be found at www.novonordisk.com/investor under conferences and abstracts.<< snip >>HAYWARD, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) invites you to listen to a conference call that will be available by phone and also broadcast over the Internet today, Tuesday, September 3, 2002, to discuss the initiation of Phase 3 trials of the AERx Diabetes Management System. What: Discuss news released earlier today announcing initiation of Phase 3 clinical trials of AERx Diabetes Management System When: Today, Tuesday, September 3, 2002 @ 4:30 p.m. Eastern, 1:30 p.m. Pacific Internet: www.aradigm.com Telephone: 1-800-289-0493 U.S. 1-913-981-5510 International How: Log on to the web at the address above or dial into the call-in number. The web cast and replay of the conference call will be available for two weeks following the call, which can be accessed at www.aradigm.com or by dialing 1-888-203-1112. International callers should dial 1-719-457-0820. The replay passcode is 578902. For further information, please contact Media, Chris Keenan, +1-510-265-9370, or Investors, Debra Catz Bannister, +1-510-265-9200, both of Aradigm Corporation.<< Cheers, Tuck

To: rkrw who wrote (137)	9/20/2002 11:29:49 AM
From: tuck	Respond to of 255

From EASD earlier this month: >>Inhaled human insulin via the AERx® insulin Diabetes Management System in combination with NPH insulin offers the same metabolic control as intensive s.c. therapy. A proof of concept trial in type 2 diabetic patients. U. Adamson1, T. Rönnemaa2, A. H. Petersen3, K. Hermansen4; 1Danderyds Sjukhus, Stockholm, Sweden, 2Turku University Hospital, Turku, Finland, 3Novo Nordisk A/S, Bagsvaerd, 4Aarhus Amtssygehus, Aarhus University Hospital, Aarhus, Denmark. Background and Aims: New modes of insulin treatment are being developed as alternative to injections in order to obtain more physiological insulin levels and to increase compliance. Among those is the AERx® insulin Diabetes Management System (iDMS) for pulmonary administration of insulin. The AERx®iDMS provides flexible insulin dosing, similar to injections, such that 1 AERx® unit delivered by inhalation corresponds approximately to the effect of 1 IU insulin given s.c. This Proof of Concept trial in type 2 diabetic patients was performed to compare the glycaemic control of pre-prandial pulmonary human insulin given via the AERx® iDMS to pre-prandial s.c. injection of human insulin, both in combination with NPH insulin at bedtime. Materials and Methods: Non-smoking patients of both sexes with type 2 diabetes on any insulin treatment were included in this multi-centre, randomized, parallel, open-labelled, 12-week trial. They were randomised to receive inhaled insulin via the AERx® iDMS immediately before meals, or s.c. injections of human insulin 30 min. before meals. Both groups received NPH insulin at bedtime. A total of 107 patients (67 males and 40 females) were exposed to trial drug and 98 patients (49 in each group) completed the trial. The AERx and s.c. groups were similar with respect to demographic and baseline characteristics, with mean age 59 years, BMI 27.7 kg/m2, fasting serum glucose 11.6 mmol/L (11.4 mmol/L vs. 11.7 mmol/L) and HbA1c 8.5% (8.6% vs. 8.5%), both AERx vs. s.c. Results: A similar decrease in HbA1c from baseline to end of trial was seen for the AERx and the s.c. groups (0.72% vs. 0.75%, p= 0.90), while decrease in fasting serum glucose was significantly larger in the AERx group (3.00 vs.0.73 mmol/L, p=0.03) with similar bedtime NPH dose in the two groups (0.27IU/kg vs. 0.25 IU/kg, p= 0.95). Comparing the AERx and s.c. groups, the intrasubject variability of fasting blood glucose was similar (30% vs. 27%, p=0.34), as was the intrasubject variability of prandial blood glucose increments (26% vs. 26%, p=0.91). Also there was no statistically significant difference between the absolute prandial blood glucose increments (1.99 vs. 1.33 mmol/L, p= 0.14). The total number of hypoglycaemic events was 151 in the AERx group and 211 in the s.c. group (N.S.). The frequency, nature and severity of adverse events (AEs) were comparable for the two groups. Most frequent AEs in both groups were headache, respiratory tract infection and diarrhoea. No clinically relevant changes were seen in mean pulmonary function tests or chest X-rays in the AERx group. Median total insulin antibody level increased in the AERx group and was unchanged in the s.c. group. No clinical signs or symptoms were reported in connection with the changes in antibodies. Conclusion: This trial shows that pulmonary insulin administered via the AERx® iDMS immediately before meals in combination with NPH is as efficacious as s.c. human insulin 30 min. before meals in combination with NPH in controlling HbA1c in insulin treated type 2 diabetic patients. No major pulmonary safety issues were seen in this trial.<< Cheers, Tuck

To: rkrw who wrote (137)	6/14/2003 7:15:13 PM
From: tuck	Read Replies (2) \| Respond to of 255

ADA abstracts came off of embargo this morning. Here's the most important one for ARDM: >>Evaluation of Lung Function in Patients with Type 2 Diabetes Using the AERx[reg] Insulin Diabetes Management System (iDMS) Abstract Number: 463-P Authors: PER WOLLMER, PER CLAUSON Institution: Malm[oslash], Sweden; Bagsvaerd, Denmark Results: Development of systems for inhalation of insulin requires close monitoring of lung function (LF). We report results of pulmonary function tests (PFT) from a multi-centre, randomized, parallel, open-labelled, 12-week study in 107 non-smoking type 2 diabetic patients where pre-prandial s.c. (n=53) and inhaled human insulin via the AERx[reg] iDMS (n=54), both in combination with NPH insulin at bedtime, were compared. The two groups were comparable, with mean age 59 years, BMI 27.7 kg/m[sup2], and HbA1c 8.5% (8.6% vs. 8.5%, AERx vs. s.c.). Both groups showed a similar decline in HbA1c after 12 weeks (7.8% vs. 7.8%, p=0.60). The aims of PFT were to 1) assess LF in diabetic patients before treatment with inhaled insulin, 2) assess changes in LF after treatment with inhaled insulin, and 3) assess the reproducibility in PFT in this multi-centre study of diabetic patients. At inclusion, forced vital capacity (FVC), total lung capacity (TLC) and forced expiratory volume (FEV1) were all significantly lower (p<0.01 in all cases) than predicted values, mean values ± SD being 96.4±13.2, 95.3±13.1, and 96.9±12.7% predicted, respectively. The FEV1/FVC ratio was significantly higher than predicted (102.9±8.6%) and the diffusing capacity for carbon monoxide (DLCO) was lower than predicted (92.4±16.7% predicted). This indicates restrictive lung function impairment in patients with type 2 diabetes. There were no significant changes in PFT in the groups after 12 weeks. LF does thus not change after 12 weeks of treatment with AERx[reg] iDMS. Two patients in the AERx[reg] group showed a decrease in PFT that were classified as adverse events by the investigators. One patient in the s.c. group had a similar decrease, not considered an adverse event by the investigator. Since LF is expected to be unchanged in patients undergoing s.c. treatment only, the intra-subject variation in PFT can be calculated in this group. Mean coefficients of variation for FVC, TLC, FEV1 and DLCO were 4.2%, 5.0%, 5.0% and 6.7%, respectively. This information about the variability of PFT in diabetic patients should be useful for the design of future trials of inhaled insulin.<< 5% AE rate in AerX group versus none in the s.c. group. Wonder what the actual numbers for those patients are, and what the underlying causes are. Not sure if this group is being subjected to chest X-Rays as in the proof of concept study presented at EASD nine months ago. No direct mention of fibrosis or whether patients were screened for it. And did Punk Ziegel know about these patients or not? Message 19029431 Here's another: >>Physicians[rsquo] Reaction to Inhaled Insulin, a New Insulin Delivery System Abstract Information Abstract Number: 456-P Authors: DAVID LUERY, DIANE CHAYER Institution: Princeton; Bagsvaerd, Denmark Results: Inhaled insulin is currently in development. This study was conducted in 2001 to determine whether or not this would be an interesting option for physicians and patients. Personal interviews (1h) obtained reactions to inhaled insulin compared to subcutaneous and evaluated 2 potential delivery systems (including AERx[reg]iDMS) in a blind test. The sample included general practitioners (313 GPs) and diabetes specialists (289 SPs) in Germany, Spain, UK and USA. Results indicate that patient fear of self-injecting is perceived as one of the most difficult aspects of initiating insulin: from 20% (UK GPs) to 58% (USA SPs); as well as concern about compliance: from 19% (UK GPs) to 45% (Germany GPs). Many physicians believe that inhaled insulin would address both of these aspects. Substantial proportions of physicians, from 35% (Germany SPs) to 62% (USA GPs), also believe that inhaled insulin would allow them to initiate insulin earlier. Two AERx[reg]iDMS features are perceived as advantages over other inhaled insulin systems: dosing in single unit increments, from 36% (UK) to 62% (US SPs); and compliance monitoring involving electronic storage of 3 months[apos] data, from 18% (Spain SPs) to 46% (UK GPs).Inhaled insulin seems to be of benefit for patients fearing injections and could facilitate insulin initiation. Moreover it is likely to lead to higher compliance. The features of an electronic system are highly valued.<< There was a table, but I couldn't get it formatted properly. Cheers, Tuck