Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aastrom Biosciences Inc.*

CB-II Therapy Kit

Produces umbilical cord blood stem cells

Leukemia

Company initiated a Phase I/II study of the kit for the production of umbilical cord blood stem cells; study will evaluate the rate of normal blood cell recovery and the survival rate of leukemia patients following AastromReplicell System-produced cord blood stem cell transplant (11/16)

Allos Therapeutics Inc. (ALTH)

RSR13

Synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, increasing oxygen delivery to hypoxic tissue

Non-small-cell lung cancer

Company said 87% of patients treated with induction chemotherapy in conjunction with radiation and RSR13 showed a complete or partial response (11/29)

Antigenics Inc. (AGEN)

Oncophage

Uses heat shock proteins to activate cellular immune responses

Pancreatic cancer

Company expanded its Phase I/II trial to include feasibility and survival as the objectives (11/27)

Atrix Laboratories Inc. (ATRX)

Leuprogel

Leuprolide acetate delivered using Atrix's Atrigel delivery system; administered as a 3-month sustained-release dose subcutaneously

Prostate cancer

Company completed enrollment in its 110-patient Phase III trial (11/21)

AVAX Technologies Inc. (AVXT)

M-Vax

Haptenized autologous cell vaccine

Melanoma

New data presented at the 18th Chemotherapy Foundation Symposium showed the 2-year survival of patients treated with M-Vax was 60%; company said the safety profile is excellent (11/13)

AVI BioPharma Inc. (AVII)

Avicine

Drug elicits a highly specific immune response to hCG; non-toxic immunotherapy

Pancreatic cancer

AVI completed patient enrollment in its Phase II trial involving 50 patients (11/14)

Biomira Inc. (BIOM; TSE:BRA)

Theratope

Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH

Metastatic breast cancer

Company said it enrolled 819 of 900 evaluable patients in its Phase III trial (11/30)

Celgene Corp. (CELG)

Thalomid (FDA-approved)

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Multiple myeloma

Updated clinical trial data showed Thalomid produced a 55% overall survival rate and a 30% event-free survival 18 months after therapy began (11/10)

Dendreon Corp. (DNDN)

Provenge

Vaccine; antigen-loaded dendritic cell therapy

Prostate cancer

Study results show the vaccine is safe and well tolerated (11/30)

EntreMed Inc. (ENMD)

Endostatin

Recombinant human Endostatin protein

Tumors

Data from Phase I trials showed no safety concerns (11/9)

Enzon Inc. (ENZN)

Prothecan

PEG-enhanced version of campothecin, believed to be a topoisomerase inhibitor

Cancer

Phase I results presented at the 11th NCI/EORTC/AACR Symposium showed the drug was well tolerated and demonstrated antitumor activity (11/7)

Genta Inc. (GNTA)

Genasense

Antisense compound; synthetic DNA strands that bind to mRNA for the bc12 gene (proto-oncogene)

Cancer

Phase I/II results published in the Nov. 18 issue of The Lancet showed Genasense reduced levels of Bcl-2 protein, caused major antitumor responses and possibly extended the life of patients, when used in combination with dacarbazine (11/17)

Gilead Sciences Inc. (GILD)

NX 211

Liposomal formulation of a novel topoisomerase 1 inhibitor

Relapsed ovarian cancer

Gilead initiated the first Phase II clinical trial of NX 211 in patients resistant to treatment with top-otecan (11/2)

Hybridon Inc. (OTC BB:HYBN)

GEM 231

Mixed-backbone oligo-nucleotide that targets the RIa regulatory subunit of protein kinase A

Cancer

Phase I data showed the drug's side effects were mild and reversible; data were presented at the 11th annual NCI/EORTC/AACR Symposium (11/10)

ImClone Systems Inc. (IMCL)

IMC C225

Designed to target and block the epidermal growth factor receptor

Irinotecan-refractory colorectal carcinoma

Preliminary results from a Phase II study demonstrated anticancer activity of the combined use of IMC C225 and irinotecan resulting in tumor shrinkage and a slowing of disease progression (11/8)

ImmunoGen Inc. (IMGN) and Smith-Kline Beecham (NYSE:SBH)

huC242-DM1/SB-408075

Tumor-Activated Prodrug

Colorectal, pancreatic and non-small-cell lung cancer

Company announced favorable safety data in a Phase I/II trial (11/10)

Introgen Therapeutics Inc. (INGN)

INGN 241

Adenoviral-mda7, apoptosis-inducing compound

Cancer

Company initiated a Phase I trial (11/30)

Isis Pharmaceuticals Inc. (ISIP)

ISIS 3521

Antisense protein kinase C-alpha inhibitor that binds to an mRNA sequence specific to PKC-alpha

Non-small-cell lung cancer

Phase I/II data presented at the 11th Annual NCI/EORTC/AACR Symposium on New Drugs in Cancer Therapy showed the drug in combination with standard chemotherapy agents has promising activity, based on survival time and response rate (11/10)

Large Scale Biology Corp. (LSBC)

ND

Vaccine

B-cell non-Hodgkin's lymphoma

Company initiated a Phase I trial designed to evaluate the vaccine's safety and preliminary immune response-generation ability (11/16)

Ligand Pharmaceuticals Inc. (LGND)

Targretin (FDA-approved)

Bexarotene capsules; synthetic retinoid analogue that selectively activates retinoid X receptors

Non-small-cell lung cancer

Company announced at the NCI/EORTC/AACR meeting that Phase I/II trial results demonstrated that Targretin in conjunction with chemotherapy yielded acceptable response rates, with beter-than-expected survival (11/8)

Magainin Pharmaceuticals Inc. (MAGN)

Squalamine

Combination therapy with standard chemotherapy of carboplatin and paclitaxel

Non-small-cell lung cancer

Company said it observed a 50% or greater reduction in tumor size in 36% of 22 Stage IIIB or Stage IV non-small-cell lung cancer patients; overall, 31% experienced objective responses at various doses (11/16)

Maret Pharmaceuticals Inc.*

MARstem

Hematopoietic therapy; peptide analogue of the human hormone angiotensin

Pancytopenia in breast cancer patients

Phase I/II trial results showed the compound reduced the frequency of certain grades of thrombocytopenia, anemia and lymphopenia; the compound exhibited an excellent safety profile (11/10)

Matrix Pharmaceuticals Inc. (MATX)

IntraDose Injectable Gel

Biodegradable gel containing cisplatin and epinephrine

Unresectable liver tumors

Phase II data showed 55% of treated patients demonstrated at least a 50% reduction in tumor size (11/29)

MGI Pharma Inc. (MOGN)

Irofulven

Hydroxymethylacylfulvene

Advanced pancreatic

Phase II data presented at the 11th NCI/EORTC/AACR Symposium on New Drugs in Cancer Therapy showed that 10 of 53 patients achieved six-month survival, the primary endpoint of the trial (11/9)

MGI Pharma Inc. (MOGN) and MethylGene Inc. (Canada)*

MG98

Second-generation mRNA inhibitor that inhibits methyltransferase

Recurrent or metastatic squamous cell cancer of the neck and head

Companies initiated a Phase II trial (11/16)

Millennium Pharmaceuticals Inc. (MLNM)

LDP-341

Proteasome inhibitor

Cancer

Preclinical and clinical studies showed the drug induces apoptosis, reduces tumor volume and shows activity in combination with standard chemotherapy agents or radiation (11/10)

Onyx Pharmaceuticals Inc. (ONXX)

CI-1042

Therapeutic virus that selectively replicates in and kills cancer cells with abnormal p53 function

Cancer

Two clinical studies presented at the NCI/EORTC/AACR Symposium on New Drugs in Cancer Therapy showed the compound in combination with total body radiation produces higher antitumor activity than each treatment strategy alone (11/13); Phase II results showed the drug replicates in tumors and causes regression in refractory head and neck cancers (11/20)

OSI Pharmaceuticals Inc. (OSIP)

OSI-774

Orally active inhibitor of the epidermal growth factor receptor

Advanced, refractory non-small-cell lung

Company said the drug produced either a partial response or evidence of disease stabilization after three months of daily oral dosing in 48% of 56 patients in a Phase II study (11/9)

Oxford BioMedica plc (UK)*

MetXia

Delivers the human gene CYP2B6 to tumors, where it produces an enzyme that converts a previously circulating prodrug into the active form of the cytotoxic cylclophosphamide

Cancer

Phase I/II data showed the product was safe and well tolerated and resulted in gene transfer to the tumors (11/15**)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131

Colorectal cancer

Company enrolled and treated the first patient in its Phase I study (11/30)

Progen Industries Ltd. (Australia; PGLAF)

PI-88

Sulfated oligosaccharide anti-angiogenic agent

Cancer

Company completed recruitment for a Phase Ib trial and is planning Phase II trials (11/27)

Ribozyme Pharmaceuticals Inc. (RZYM)

Angiozyme

Antiangiogenic ribozyme targeting vascular endothelial growth factor

Cancer

Results of a Phase I/II trial reported at the annual European Organization for Treatment of Cancer Conference showed Angiozyme was well tolerated and demonstrated good bioavailability (11/9)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Synthetic immunostimulant peptide

Malignant melanoma

Company initiated a clinical study designed to evaluate Zadaxin's ability to enhance immunity, elevate T-cell counts and contribute to specific melanoma immune response (11/20)

SuperGen Inc. (SUPG)

Decitabine

Inhibits DNA methyltransferase activity

Sickle cell anemia; myelodysplastic syndrome; chronic myelogenous leukemia

Company said its anticancer compound generated a 100% response in anemia patients test in a Phase I/II study; the data were published in the October issue of Blood (11/2); company said three studies show the drug produced a response rate in 49% of 125 myelodysplastic syndrome patients tested and a 62% response rate among 81 chronic myelogenous leukemia patients (11/8)

SuperGen Inc. (SUPG)

Nipent

Pentostatin

Refractory blood cancers

Data from two studies indicate Nipent in combination therapy with Rituximab produces response rates of nearly 100%; a study of pentostatin and cyclophosphamide in patients with chronic lymphocytic leukemia produced a response rate of 71% in 14 evaluable patients and 22% in the 21 patients enrolled (11/13)

Telik Inc. (TELK)

TLK286

Small-molecule drug, developed with Telik's TRAP chemogenetics technology, that targets tumors that overexpress GST P1-1

Advanced solid tumors or non-Hodgkin's lymphoma that has resisted standard therapy

Positive interim Phase I results< were presented at the 11th annual NCI/EORTC/AACR Symposium on New Drugs in Cancer Therapy showing the drug was well tolerated (11/8) /TD>

XOMA Ltd. (XOMA)

ING-1 Human Engineered monoclonal antibody<

Designed to bring about tumor death by recognizing and binding to the EpCAM antigen

Cancer

Xoma initiated a Phase I study of its antibody in cancer patients (11/1)

CARDIOVASCULAR

Andrx Corp. (ADRX)

Lovastin XL

HMG-CoA reductase inhibitor

Dyslipidemia

Company completed the pivotal Phase III trials of Lovastin XL to treat patients with dyslipidemia at risk for cardiovascular disease; company expects to file an NDA in the first quarter of 2001 (11/13)

Avant Immunotherapeutics Inc. (AVAN)

TP10

Soluble form of complement receptor 1, designed to inhibit complement proteins

Cardiopulmonary bypass surgery

Avant began a 600-patient, placepo-controlled Phase II trial of TP10designed to assess its ability to mitigate injury to the heart, brain and other organs while patients are placed on cardiopulmonary bypass circuits (11/27)

AVI BioPharma (AVII)

Neugene

Antisense drug

Cardiovascular restenosis

Company announced the completion of a Phase I trial showing the drug did not display any safety issues; Neugene now is in a Phase II study; the company expects to begin additional trials in cancer and polycystic kidney disease (11/9)

COR Therapeutics (CORR) and Schering-Plough (NYSE:SGP)

Integrilin

Anti-platelet agent; GP IIb-IIIa inhibitor

Myocardial infarction

Phase II results presented at the 2000 Scientific Sessions of the American Heart Association show Integrilin combined with half-dose alteplase significantly improved blood flow through clogged arteries, compared with full-dose alteplase alone; preliminary results from another Phase II study of Integrilin with reduced-dose TNKase showed patients achieved restoration of blood flow at 60 minutes and displayed similar adverse reactions as with full-dose TNKase alone (11/14)

Corvas International Inc. (CVAS)

UK-279,276

recombinant neutrophil inhibitory factor

Acute stroke

Pfizer initiated a Phase IIb dose-ranging study to determine the efficacy and safety of the agent (11/28)

CV Therapeutics Inc. (CVTX)

CVT-510

Selective A1 adenosine receptor agonist

Paroxysmal supraventricular tachycardia (PVST) (atrial arrhythmia)

Phase II results presented at the 73rd Scientific Sessions of the American Heart Association indicate CVT-510 terminated PVST without adversely affecting blood pressure (11/14)

CV Therapeutics Inc. (CVTX) and Fujisawa Healthcare Inc. (unit of Fujisawa Pharmaceutical Co. Ltd.; Japan)

CVT-3146

A selective A2A adenosine receptor agonist

Cardiac perfusion

Companies initiated a Phase I trial (11/29)

Discovery Laboratories Inc. (DSCO)

Surfaxin

Peptide sinapultide

Acute respiratory distress syndrome

Company received clearance to begin a Phase II trial in 110 patients (11/16)

Esperion Therapeutics Inc. (ESPR)

ApoA-I Milano

A variant of ApoA-1 that is believed to protect against vascular disease by extracting cholesterol from the artery wall and transporting it to the liver for removal

Cardiovascular and metabolic diseases

Company initiated a Phase I trial (11/9)

Esperion Therapeutics Inc. (ESPR)

LUVs

Unilamellar vesicles; spherical particles comprised of naturally occuring lipids that recirculate through arteries

Vascular disease

Company completed its Phase I trial, which showed evidence of cholesterol mobilization and excretion (11/28)

Pharmacyclics Inc. (PCYC)

Antrin

Motexafin lutetium injection

Coronary artery disease

Phase I results presented at the 73rd Scientific Sessions of the American Heart Association show the treatment is well tolerated (11/14)

Scios Inc. (SCIO)

Natrecor

Recombinant form of B-type natriuretic peptide

Heart failure

Phase III data presented at the 73rd Scientific Sessions of the American Heart Association showed the drug met all end-points; Natrecor improved both the hemodynamic measures associated with acute decompensated congestive heart failure and alleviated dyspnea, or difficulty breathing (11/15)

Texas Biotechnology Corp. (AMEX:TXB)

Sitaxsentan

Oral endothelin A receptor antagonist

Essential hypertension and pulmonary hypertension

Results from two clinical studies showed patients experienced statistically significant improvements in exercise capacity and hemodynamic improvement, as well as statistically significant reductions in blood pressure; data were presented at the 73rd Scientific Sessions of the American Heart Association (11/10)

CENTRAL NERVOUS SYSTEM

Acorda Therapeutics Inc.*

Fampridine SR

Pharmaceutical-grade oral sustained-release formulation of 4-aminopyridine designed to block specialized potassium channels on axons; SR is a nerve conduction-enhancing compound

Multiple sclerosis

Company began a Phase II study that will enroll 30 patients (11/28)

CV Therapeutics Inc. (CVTX)

Ranolazine

Anti-anginal drug; pFOX (partial Fatty Acid Oxidation) inhibitor

Chronic angina pain

Clinical results presented at the 73rd Scientific Sessions of the American Heart Association suggest ranolazine produces statistically significant increases in exercise duration and time to angina pain, compared to placebo in both younger and older patients (11/14)

Pozen Inc. (POZN)

MT100

Oral migraine pain therapeutic

Migraine pain

Company completed two Phase III trials; data will be available in early 2001 (11/28)

Pozen Inc. (POZN)

MT400

Combination triptan/nonsteroidal anti-inflammatory

Migraine pain

Company began a Phase II trial with 800 patients (11/28)

The Immune Response Corp. (IMNR)

BV5S2, BV6S5, BV13S1

T-cell receptor peptide vaccines combined in Incomplete Freund's Adjuvant, a general immune stimulant

Multiple sclerosis

Company initiated a Phase I/II trial in MS involving 60 patients over 24 weeks (11/14)

DIABETES

Alkermes Inc. (ALKS)

Inhaled insulin

Administered from small, simple inhalers

Diabetes

Company completed and analyzed prelininary results from the first clinical trial and initiated a second study (11/27)

Amylin Pharmaceuticals Inc. (AMLN)

AC2993

Synthetic exendin-4; a 39-amino acid peptide

Type II diabetes

Company initiated a Phase II study of AC2993 in more than 100 subjects (11/2)

Insmed Inc. (INSM)

INS-1

Oral insulin sensitizer

Type II diabetes

Preliminary intent-to-treat analysis showed the drug in combination with sulfonylureas showed no statistical significance from placebo (11/27)

Insmed Inc. (INSM)

SomatoKine

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Type II diabetes

Initial data from a Phase II study showed the drug reduced insulin consumption and average daily blood glucose (11/27)

Kos Pharmaceuticals Inc. (KOSP)

Niaspan

Formulation of niacin with a statin

Adult-onset diabetes diabetes

Summary findings from a 16-week study of Niaspan in treating lipid abnormalities indicate the drug significantly improves the critical lipoprotein abnormalities in patients without affecting their blood sugar levels (11/14)

INFECTION

Aquila Biopharmaceuticals Inc. (AQLA)

QS-21

Stimulon adjuvant

Flu

Aquila initiated clinical trials of QS-21 as a flu vaccine (11/13)

MedImmune Inc. (MEDI)

Snyagis

Palivizumab; humanized monoclonal antibody< /TD>

Respiratory syncytial virus

Results from two studies show the antibody significantly reduces the rate of hospitalization among high-risk infants (11/20)

Micrologix Biotech Inc. (Canada; TSE:MBI)

MBI 853NL

Anti-infective; intranasally delivered

Staphylococcus aureus infection

Company initiated a Phase Ib trial (11/29)

Progenics Pharmaceuticals Inc. (PGNX)

PRO 542

Fusion protein that incorporates HIV binding region of human cell surface receptor (CD4) into a human antibody molecule; binds to GP120

HIV

Patient treatment has begun in a Phase II study; Phase I/II results were published in the December issue of The Journal of Infectious Diseases (11/28) < /TD>

Vertex Pharmaceuticals Inc. (VRTX) and Glaxo Wellcome (unit of Glaxo Wellcome plc; UK; NYSE:GLX)

VX-175 (GW433908)

Prodrug of the approved protease inhibitor Agenerase (amprenavir)

HIV

VX-175 entered two separate, 48-week, Phase III pivotal trials (11/27)

MISCELLANEOUS

Alkermes Inc. (ALKS)

Medisorb Naltrexone

Injectable sustained-release formulation

Alcoholism and opiate abuse

Trial results indicated the formulation maintained therapeutic levels in the bloodstream for a month following injection (11/21)

Angiotech Pharmaceuticals Inc. (ANPI)

Micellar paclitaxel

Intravenous therapy of FDA-approved paclitaxel

Severe psoriasis

Angiotech initiated a pilot Phase II study of six patients (11/20)

Aquasearch Inc. (OTC BB:AQSE)

AstaFactor

Oral astaxanthin-rich algae extract

Exercise-induced asthma

Company will begin a 60-patient clinical trial measuring the compound's ability to decrease airway obstruction (11/17)

BioChem Pharma Inc. (BCHE)

Zeffix (FDA-approved as Epivir-HBV)

Lamivudine; nucleoside

Cirrhosis analogue (oral)

A study presented at the American Association for the Study of Liver Diseases Congress showed a regression in cirrhosis in 64% of patients with pre-existing cirrhosis following two or more years of treatment with Zeffix (11/1)

Biomarin Pharmaceutical Inc. (BMRN) and Genzyme General Corp. (GENZ)

Aldurazyme

Recombinant alpha-L-iduronidase

Muccopoly-saccharidosis-1

Companies entered a pivotal Phase III study with Aldurazyme (11/22)

Biomatrix Inc. (NYSE:BXM)

Synvisc (FDA-approved)

Hylan G-F20

Hip osteoarthritis

Study presented at the 64th Annual Meeting of the American College of Rheumatology showed patients exhibited significant and sustained symptomatic relief (11/1)

Chiron Corp. (CHIR)

TOBI

Tobramycin solution for inhalation

Cystic fibrosis

Data supports the early use of TOBI for cystic fibrosis patients with early lung infections (11/10)

Corixa Corp. (CRXA)

AnergiX.RA complex

Consists of solubilized HLA DRB1*0401 together with a specific peptide from the human cartilage glyco-protein HCgp39

Rheumatoid arthritis

Phase I/II results presented at the American College of Rheumatology meeting showed the complex was well tolerated and had biological activity (11/2)

Epigenesis Pharmaceuticals Inc.*

EPI-2010

Targets the adenosine A1 receptor

Asthma

Company began a Phase I study (11/2)

Genmab AS (CSE:GEN; Neuer:GE9)

HuMax-CD4

Fully human antibody

Rheumatoid arthritis

Company announced positive Phase I/II results showing the drug was well tolerated; results were presented at the American College of Rheumatology Meeting (11/1)

Immunex Corp. (IMNX) and Wyeth-Ayerst Laboratories (unit of American Home Products Corp.; NYSE:AHP)

Enbrel

Etancercept (FDA-approved)

Uveitis

Results presented at the 64th Annual Meeting of the American College of Rheumatology showed a decrease in inflammation of the uveal tract in 63% of eyes; the trial involved 10 children with chronically active uveitis (11/1)

Immunex Corp. (IMNX)

Enbrel (FDA-approved)

Etancercept

Rheumatoid arthritis

Clinical data published in The New England Journal of Medicine show that Enbrel can delay progression of structural joint damage in patients with moderately to severely active rheumatoid arthritis (11/30)

Inspire Pharmaceuticals Inc. (ISPH)

INS365

P2Y(2) receptor agonist

Dry eye disease

Inspire announced positive results from a Phase II study at the Association for Research in Vision and Ophthalmology meeting; it will soon start a Phase III trial (11/6)

Micrologix Biotech Inc. (Canada; TSE:MBI)

MBI 594AN

Bactolysin compound (cationic peptide)

Acne

Company initiated a Phase II trial in 75 patients (11/6)

Neurogen Corp. (NRGN) and Pfizer Inc. (NYSE:PFE)

NGD 91-3

Modulates specific GABA receptor subtypes

Anxiety disorder

Companies initiated a Phase I study (11/29)

NexMed Inc. (NEXM)

Alprox TD

Topical treatment

Male erectile dysfunction

NexMed announced Phase II results showing three different dose levels of Alprox-TD were effective over placebo in sexual function endpoint analyses (11/2)

NicOx SA (France; Nouveau Marche:NICOX)

HCT 1026

Novel nitric oxide-releasing derivative of the non-steroidal anti-inflammatory compound, flurbiprofen

Skin inflammation

NicOx said HCT 1026 showed potent anti-inflammatory activity and the local and general safety of the ointment was excellent (11/28)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor

Obesity

Company said Phase II results showed patients had statistically significant weight loss with Axokine as compared to placebo (11/28)

StressGen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Recombinant fusion protein composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7 from HPV type 16

Anal dysplasia

StressGen initiated patient treatment in a Phase III trial; trial will be double-blind, placebo-controlled, involving 128 patients (11/6)

Targeted Genetics Corp. (TGEN)

tgAAV-CF

Aerosolized; gene therapy; use of adeno-associated viral vector to deliver normal CFTR (cystic fibrosis transmembrane regulator) gene into nasal passage

Cystic fibrosis

The first patient in a Phase II trial received the drug at Stanford University Medical Center, triggering a $2M milestone payment from Celltech Group plc, of the UK (11/17)

Vasogen Inc. (Canada; TSE:VAS; AMEX:MEW)

VasoCare

Targets immune processes that lead to inflammatory damage to the lining of blood vessels

Peripheral artery disease

Data showed the drug achieved its primary endpoint; patients treated with VasoCare showed a greater than 50% increase in walking distances compared to placebo (11/29)