Navigation Links
Alchemia Reports Preliminary Positive Efficacy Data From HyCAMP,Phase II Trial

SYDNEY, Australia, April 26, 2007 /PRNewswire-FirstCall/ -- Australian drug development company Alchemia Limited today announced preliminary results from its randomised Phase II clinical trial in patients with metastatic colorectal cancer, where Alchemia's drug HyCAMP(TM) was compared to irinotecan which is considered to be a cornerstone drug for the treatment of colorectal cancer. This announcement is being made at a preliminary stage of the analysis in accordance with the ASX disclosure requirements once the company became aware of the results reported below.

Primary safety endpoint - Comparison of the incidence of late grade 3 or 4 diarrhoea in patients receiving HyCAMP(TM) versus irinotecan alone:

    -- not met due to lower than expected incidence of diarrhoea in the

       control arm

    Secondary safety endpoints:

    -- No major differences in overall adverse events between the two

       treatment arms

    Secondary efficacy endpoints:

    -- 38 of 41 (93%) HyCAMP(TM) patients compared to 28 of 35 (80%)

       irinotecan patients completed 2 cycles (p=0.099)

    -- 14 of 41 (34%) HyCAMP(TM) patients compared to 5 of 35 (14%) irinotecan

       patients completed the full 8 cycles (p=0.064)

    -- Patients on HyCAMP(TM) received a median of 6 cycles of therapy,

       compared to 2 for irinotecan alone (p=0.005)

    -- Median progression free survival for HyCAMP(TM) patients was 5.2

       months, compared to 2.4 months for the irinotecan arm (p=0.014).

The Phase II trial commenced in December 2004 and patient accrual closed on 30 June 2006. In the randomised trial, 80 patients with metastatic colorectal cancer who had previously failed treatment with the anti-cancer drug 5-fluoro uracil were eligible to receive up to eight cycles of chemotherapy in the form of irinotecan or HyCAMP(TM) intravenously. The primary endpoint of the trial was safety (incidence of Grade 3/4 diarrhoea) with secondary safety and efficacy endpoints such as disease control, progression free survival and overall survival.

The major findings from the preliminary analysis of trial data are as follows. The two arms of the study were very well balanced for known prognostic factors. Preliminary data regarding toxicity indicates no major differences between the two arms, with an overall impression that HyCAMP(TM) was associated with less cumulative toxicity because the HyCAMP(TM) arm received significantly more doses. The overall incidence of grade 3/4 diarrhoea was lower in this study (14%) than anticipated at the commencement of the trial, presumably reflecting improved medical management today of this side effect in patients, and thereby impeding any meaningful analysis of this endpoint. Patients on HyCAMP(TM) received a median of 6 cycles of therapy, compared to 2 for irinotecan alone (p=0.005). Median progression free survival for HyCAMP(TM) patients was 5.2 months, compared to 2.4 months for the irinotecan arm (p=0.014). Preliminary data indicates the proportion of patients exhibiting disease control (complete responses, partial responses or stable disease) in the HyCAMP(TM) arm was at least 40 % greater than that observed in the irinotecan arm.

Analysis of the trial data is ongoing and full results will be presented when available. This is expected by the end of May. However, from the data analysed to date, HyCAMP(TM) is able to deliver more cycles of therapy and this has translated into an improved disease control rate, and a statistically significant improvement in progression free survival. "The findings have far exceeded our expectations in that we did not expect to achieve a statistically significant improvement in efficacy from such a small number of patients" commented principal investigator Associate Professor Peter Gibbs. Alchemia CEO Dr Ramsdale said "we will be moving as quickly as possible to discuss our plans for fut ure studies with the FDA. We are hopeful that these results will enable us to move forward to a pivotal phase III study earlier than originally anticipated."

These results are important not only for the development and approval path for HyCAMP(TM) itself but they provide validation of the technology platform. The HyACT(TM) platform is an extremely flexible formulation technology as it can be used with virtually any intravenously administered anti-cancer treatment. We have successfully completed Phase I clinical studies on HyACT(TM) formulations of two other chemotherapy drugs, doxorubicin and 5- flurouracil. Encouraging preclinical data has also been obtained on a number of other cytotoxics. More recently, we have demonstrated in preclinical studies that HyACT(TM) can also be used to significantly enhance the efficacy of newer targeted antibody therapies such as Avastin(TM) and Erbitux(TM) In the case of generic drugs or drugs close to patent expiry, the HyACT(TM) formulation may provide a means for companies to differentiate their products from other competitors in the market place, and thereby build product value.

HyCAMP(TM) and the proprietary formulation technology, HyACT(TM), were obtained following the successful acquisition of Melbourne based oncology company Meditech Research Limited in 2006. "The Phase II clinical results provide proof of concept for the HyACT(TM) platform. We expect this technology to build substantial value for shareholders, not only with HyCAMP(TM), but with other oncology drugs as well" Dr Ramsdale said.

Before HyCAMP(TM) can be marketed in the US, the drug needs to successfully complete a Phase III study, and receive marketing approval from the US FDA.

Alchemia wishes to acknowledge the commitment and thank the patients who volunteered to participate in this trial, and to acknowledge and thank the investigators, study research personnel and nursing staff at the 10 clinical sites across Australia who looked a fter the welfare of the patients and diligently collected the data for analysis in this trial.

    ENQUIRIES: Dr. Tracie Ramsdale

    Chief Executive Officer

    Alchemia Limited

    Tel: +61-7-3340-0200


    Ms Anna Whybird

    Phillips Group

    Tel: +61-7-3230-5000

About HyACT

HyACT(TM) is a proprietary delivery technology which utilises Hyaluronic acid (HA), to deliver and enhance the retention of anti-cancer drugs within tumours. The drug becomes entrapped in a matrix of HA which binds to HA receptors located on the tumour resulting in more of the drug being delivered to the tumour cells. In preclinical studies, the HyACT(TM) technology has demonstrated improved delivery of the drug to the tumour resulting in significantly reduced toxicity and increased efficacy and survival.

About Irinotecan

Irinotecan is widely used in the treatment of metastatic colorectal cancer, and is being evaluated in many other tumour types. Like most cytotoxics the use of irinotecan is restricted by its side effects, the most significant of which are diarrhoea and neutropenia, and limited activity in some patients. Sales of Pfizer's irinotecan (Camptosar(R) ) were US$903 million in 2006, and patent exclusivity for the drug expires in 2008 in the US and 2009 in the EU.

About HyCAMP(TM)

HyCAMP(TM) is a proprietary formulation of the anti-cancer drug irinotecan. Preclinical studies with HyCAMP(TM) demonstrated improved delivery of the drug to the tumour, resulting in increased efficacy and reduced toxicity. The phase II clinical trial was initiated to evaluate HyCAMP(TM) in patients with metastatic colorectal cancer.


The following additional information is provided in accordance with the Code of Best Practice for ASX Reporting by Life Science Companies

    Trial Title        Randomised Phase II Trial of irinotecan with Hyaluronic

                       Acid (HyCAMP(T
M)) versus irinotecan as treatment for

                       patients with metastatic colorectal cancer who have

                       failed 5-FU based chemotherapy

    Blinding Status    Open label, randomised

    Treatment Method   HyCAMP(TM) arm:

                       Irinotecan: 350mg/mm2 day 1 every 3 weeks or

                       300 mg/mm2 day 1 every 3 weeks for age 70-75

                       HA: 1000 mg/mm2 day 1 every 3 weeks

                       Irinotecan arm:

                       Irinotecan: 350mg/mm2 day 1 every 3 weeks or

                       300 mg/mm2 day 1 every 3 weeks for age 70-75

                       Duration of treatment: maximum of 8 cycles

                       Route of administration: intravenous

    No of subjects     80

    Key Subject Selection Criteria   Metastatic colorectal cancer

                                     Failure of previous fluorouracil

                                     chemotherapy, Adequate major organ

                                     function ECOG PS (performance score) 0-1.

                                     Age 18-75 years

    Trial Location                   10 sites in Australia

    Primary endpoint                 Comparison of the incidence of late grade

                                     3 or 4 diarrhoea in patients receiving

                                     HyCAMP(TM) versus irinotecan alone

    Main Secondary safety end points

    1. Incidence of grade 3 or 4 diarrhoea in cycle 1 or cycle 2

    2. Requirement for dose reduction for any cause after 2 cycles of therapy

    3. Requirement for dose reduction for any reason

    4. Overall incidence of grade 3 or 4 neutropenia

    5. Overall adverse events

    Main Secondary efficacy end points

    1. Number of patients completing 2 cycles of therapy

    2. Number of patients completing 8 cycles of therapy

    3. Median number of cycles delivered

    4. Disease Control Rate

    5. Median
 Progression Free Survival

    6. Median Overall Survival

    7. 50% or greater decline in CEA levels

    8. Time to treatment failure Study Results

    Study Results

    Patient demographics

                                 Control       HyCAMP(TM)      Overall

                                 (n = 35)       (n = 41)      (n = 76)

    Sex                  Male    21 (60.0)     24 (58.5)     45 (59.2)

                         Female  14 (40.0)     17 (41.5)     31 (40.8)

    Age (Years)          n             35            41            76

                         Median     63.11         62.30         62.67

    ECOG Status          0             16            19            45

                         1             19            22            31

    Prior oxaliplatin

     therapy             n             30            34            64

    Primary Endpoint

    1. Incidence of grade 3 or 4 diarrhoea in HyCAMP(TM) arm versus irinotecan


       The overall incidence of Grade 3/4 diarrhoea (14%) was much lower than

       anticipated (30%) making analyses of this end point futile. There was

       no statistically significant difference in the incidence of grade 3 or

       4 diarrhea in the HyCAMP(TM) arm versus the irinotecan arm.

    Secondary safety endpoints

    1. Incidence of grade 3 or 4 diarrhoea in cycle 1 or cycle 2

       see comment above for primary end-point all but one case of diarrhoea

       occurred in Cycle 1

    2. Requirement for dose reduction for any cause after 2 cycles of therapy

       to be determined

    3. Requirement for dose reduction for any reason

       to be determined

    4. Overall incidence of grade 3 or 4 neutropenia

       to be determined

    5. Overall adverse events -

       no major differences between treatment arms

    Secondary Efficacy Endpoints

    1. Number of patients completing two cycles of therapy

       38 of 41 (93%) HyCAMP(TM) patients compared to 2
8 of 35 (80%)

       irinotecan patients completed 2 cycles (p=0.099)

    2. Number of patients receiving full 8 cycles

       14 of 41 (34%) HyCAMP(TM) patients compared to 5 of 35 (14%) irinotecan

       patients completed 8 cycles (p=0.064)

    3. Median number of cycles delivered

       Patients on HyCAMP(TM) received a median of 6 cycles of therapy

       compared to 2 for irinotecan alone (p=0.005).

    4. Disease control rate (Complete Response + Partial Response + Stable


       The proportion of patients exhibiting disease control was at least

       40% higher in the HyCAMP(TM) arm than the control (analysis partially


    5. Median progression free survival

       Mean progression free survival was 5.2 months for HyCAMP(TM) vs 2.4

       months for the control arm (p=0.014).

Please refer to graph available via announcement on the Australian stock exchange (ASX).

    6. Median overall survival

       To be determined

    7. 50% or greater decline in CEA levels

       To be determined

    8. Time to treatment failure

       To be determined

    Principal Investigator

    Assoc. Prof Peter Gibbs, Royal Melbourne Hospital and Western Hospital

CONTACT: Dr. Tracie Ramsdale, Chief Executive Officer, Alchemia Limited,+61-7-3340-0200; Ms Anna Whybird, Phillips Group, +61-7-3230-5000, forAlchemia Limited

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
3. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
4. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
5. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
6. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
7. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
8. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
9. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
10. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
11. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
Post Your Comments:
(Date:10/8/2015)... , Oct. 8, 2015  Ardelyx, Inc. (NASDAQ: ... on gastrointestinal and cardio-renal diseases, today announced that ... tenapanor, will be presented at the 2015 American ... will include measures of sustained response in IBS-C ... placebo-controlled, randomized Phase 2 trial. The meeting will ...
(Date:10/8/2015)... 2015  Trovagene, Inc., (NASDAQ:   TROV) a ... presentation of results from a field experience analysis ... SM (PCM) platform to accurately identify mutational ... determine appropriate therapy for patients. Mark Erlander ... delivering the results today in an oral presentation ...
(Date:10/8/2015)... 2015  Following months of investigation, Ross Feller Casey ... alleging that the anticoagulant Xarelto,s recommended dosage doesn,t work for ... Philadelphia on behalf of a ... the drug didn,t work as the manufacturer suggested. Ross ... shortly on behalf of clients from across the country with ...
Breaking Medicine Technology:
... CLARA, Calif., Oct. 7, 2011 ProteinSimple today ... and field service support for its biologics products ... product lines are included in this expanded support ... Micro-Flow Imaging systems. The biologics market ...
... (Nasdaq: CPHD ) today announced that it will ... 30, 2011, on Thursday, October 20, 2011, after the close ... management presentation at 2 p.m. Pacific Time on Thursday, October ... webcast, please visit Cepheid,s website at at ...
Cached Medicine Technology:
(Date:10/10/2015)... ... ... The sixth annual cost of cybercrime study the Ponemon Institute released this ... The New York Times broke down some of those numbers in this article ... the companies surveyed, it only proves that regular threat assessments, penetration testing and emergency ...
(Date:10/10/2015)... ... ... Story Chaser is a one-of-a-kind app that makes reading fun while helping children ... words drop down and users tap the corresponding word. By answering correctly player earn ... making it a more engaging game. Users can use what are called Reading Powers ...
(Date:10/10/2015)... Arbor, MI (PRWEB) , ... October 10, 2015 , ... ... City, MO. , On the heels of the release of the Institute of ... of tools, and their integration with Cerner solutions that assist healthcare providers and consumers ...
(Date:10/10/2015)... ... October 10, 2015 , ... In the inaugural people’s choice contest, ... Place To Work in Jacksonville, amongst medium-sized companies with 25 – 99 employees. The ... up with a celebratory gala on October 1st. , Many of the features ...
(Date:10/9/2015)... ... October 09, 2015 , ... ... the Pacific Associate Dean for Graduate Medical Education J. Michael Finley, DO, as ... Award. Finley was selected for his impact on graduate medical education opportunities for ...
Breaking Medicine News(10 mins):
... CardioCareLive, the world,s largest live online cardiology congress ... Medicine, today announced three new complimentary Continuing Medical ... days on Tuesday June 28th and Wednesday June ... and internal medicine and family care physicians in ...
... latest episode in the American Chemical Society,s (ACS) ... focuses on new blood test that can quickly ... bacterium that,s become a global threat, significantly improving ... Staphylococcus aureus, or simply MRSA. The podcast explains ...
... 24 (HealthDay News) -- Rain-making bacteria may shed some ... the Earth,s precipitation cycle, new research shows. ... meeting of the American Society for Microbiology in New ... of hailstones, suggesting that airborne microorganisms may trigger precipitation, ...
... knowledge of tuberculosisas well as in the practices, programs ... with human immunodeficiency virus (HIV)the spread of multidrug-resistant (MDR) ... community. Research in the June issue of The ... use of 18F-FDG positron emission tomography (PET) scans can ...
... MA Electronic medical records (EMRs) have been in use ... utilization in recent years, due in part to research supporting ... become a standard in medical care, there is a need ... be refined. A group of researchers from Brigham and Women,s ...
... you may want to think twice before shooting hundreds of ... study from MIT neuroscientists shows that the most memorable photos ... and human-scale objects. Landscapes? They may be beautiful, but they ... are not the same," says MIT graduate student Phillip Isola, ...
Cached Medicine News:
The MACS VA_500 (variable atmosphere) is primarily for the study and isolation of microaerophilic organisms,including Campylobacter spp,Helicobacter pylori and other similarly fastdious organisms....
... an electrical power supply, MERKUR offers a broad ... a gas spring for ease of operation. For ... a foot pedal hydraulic system. Thanks to its ... anytime in a highly mobile and flexible manner. ...
... The operating table MARS Enduro ... examinations or interventions are required before, ... Due to the motorised longitudinal adjustment ... provides optimum working conditions in examination, ...
... Exclusive, 210° Top Rotation provides uncommon ... surgery. The Hercules 6700B eliminates any ... head-end procedures, while providing ample leg ... sit during procedures. Removable back and ...
Medicine Products: