HEPH » Topics » Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter

This excerpt taken from the HEPH 10-Q filed May 14, 2009.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND, for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

   

Phase II clinical trial with TRIOLEX (HE3286) in the United States in type 2 diabetes patients under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of ulcerative colitis;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States in rheumatoid arthritis patients under an IND for the treatment of diseases of inflammation; and

 

   

Phase I/II clinical trial with APOPTONE™ (HE3235) in the United States in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment under an IND for the treatment of hormone-sensitive cancers including prostate cancer.

 

18


Table of Contents

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

This excerpt taken from the HEPH 10-K filed Mar 31, 2009.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

 

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND, for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

   

Phase II clinical trial with TRIOLEX (HE3286) in the United States in type 2 diabetes patients under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of ulcerative colitis;

 

19


   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States in rheumatoid arthritis patients under an IND for the treatment of diseases of inflammation; and

 

   

Phase I/II clinical trial with APOPTONE (HE3235) in the United States in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment under an IND for the treatment of hormone-sensitive cancers including prostate cancer.

 

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

 

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

 

This excerpt taken from the HEPH 10-Q filed Nov 6, 2008.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an Investigational New Drug Application, or an IND, for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

17


Table of Contents
   

Phase II clinical trial with TRIOLEX (HE3286) in the United States in type 2 diabetes patients under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States in rheumatoid arthritis patients under an IND for the treatment of diseases of inflammation; and

 

   

Phase I/II clinical trial with APOPTONE™ (HE3235) in the United States in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment under an IND for the treatment of hormone-sensitive cancers including prostate cancer.

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

This excerpt taken from the HEPH 10-Q filed Aug 7, 2008.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an Investigational New Drug Application, or an IND, for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

   

Phase II clinical trial with TRIOLEX (HE3286) in the United States in type 2 diabetes patients under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States in rheumatoid arthritis patients under an IND for the treatment of diseases of inflammation; and

 

   

Phase I/II clinical trial with APOPTONE™ (HE3235) in the United States in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment under an IND for the treatment of hormone-sensitive cancers including prostate cancer.

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

17


Table of Contents
   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

This excerpt taken from the HEPH 10-Q filed May 7, 2008.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an Investigational New Drug Application, or an IND, for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis

 

   

Open IND to begin clinical trials with TRIOLEX (HE3286) for the treatment of rheumatoid arthritis; and

 

   

Open IND for APOPTONE to initiate Phase I/II clinical trials for the treatment of hormone-sensitive cancers including prostate cancer.

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

 

17


Table of Contents

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

These excerpts taken from the HEPH 10-K filed Mar 20, 2008.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

 

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis

 

   

Open IND to begin clinical trials with TRIOLEX (HE3286) for the treatment of rheumatoid arthritis; and

 

   

Pending IND for APOPTONE to initiate Phase I/II clinical trials for the treatment of hormone-sensitive cancers including prostate cancer.

 

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

 

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

 

22


Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our
preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

SIZE="1"> 

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:


 







  

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Open IND to begin clinical trials with TRIOLEX (HE3286) for the treatment of rheumatoid arthritis; and

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Pending IND for APOPTONE to initiate Phase I/II clinical trials for the treatment of hormone-sensitive cancers including prostate cancer.

 

We may encounter problems with some or all
of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing
and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in
completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the
analysis of the results of studies of our drug candidates:

 







  

we may not have the financial resources to continue research and development of any of our drug candidates;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

we may lose any competitive advantage associated with early market entry; and

SIZE="1"> 







  

our ability to generate revenues may be delayed.

 

STYLE="margin-top:0px;margin-bottom:0px; text-indent:4%">Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

delays in enrolling volunteers;

 







  

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 







  

lower than anticipated retention rate of volunteers in a clinical trial;

SIZE="1"> 







  

unfavorable efficacy results;

 







  

serious side effects experienced by study participants relating to the drug candidate;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 







  

new communications from regulatory agencies about how to conduct these studies; or

SIZE="1"> 







  

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

STYLE="margin-top:0px;margin-bottom:0px"> 


22








These excerpts taken from the HEPH 10-K filed Mar 17, 2008.

Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

 

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:

 

   

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases

 

   

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis

 

   

Open IND to begin clinical trials with TRIOLEX (HE3286) for the treatment of rheumatoid arthritis; and

 

   

Pending IND for APOPTONE to initiate Phase I/II clinical trials for the treatment of hormone-sensitive cancers including prostate cancer.

 

We may encounter problems with some or all of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of the results of studies of our drug candidates:

 

   

we may not have the financial resources to continue research and development of any of our drug candidates;

 

   

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

 

   

we may lose any competitive advantage associated with early market entry; and

 

   

our ability to generate revenues may be delayed.

 

Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

 

   

delays in enrolling volunteers;

 

   

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 

   

lower than anticipated retention rate of volunteers in a clinical trial;

 

   

unfavorable efficacy results;

 

   

serious side effects experienced by study participants relating to the drug candidate;

 

   

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

 

   

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 

   

new communications from regulatory agencies about how to conduct these studies; or

 

   

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

 

22


Delays in the conduct or completion of our preclinical or clinical studies or the analysis of the data from our
preclinical or clinical studies may result in delays in our planned filings for regulatory approvals, or adversely affect our ability to enter into collaborative arrangements.

SIZE="1"> 

The current status of our drug candidates is set forth below. We have either completed or are in the midst of:


 







  

Phase I clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for the treatment of metabolic diseases

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Phase I/II clinical trial with TRIOLEX (HE3286) in the United States under an IND for ulcerative colitis

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Open IND to begin clinical trials with TRIOLEX (HE3286) for the treatment of rheumatoid arthritis; and

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

Pending IND for APOPTONE to initiate Phase I/II clinical trials for the treatment of hormone-sensitive cancers including prostate cancer.

 

We may encounter problems with some or all
of our completed or ongoing studies that may cause us or regulatory authorities to delay or suspend our ongoing studies or delay the analysis of data from our completed or ongoing studies. We rely, in part, on third parties to assist us in managing
and monitoring our preclinical and clinical studies. We generally do not have control over the amount and timing of resources that our business partners devote to our drug candidates. Our reliance on these third parties may result in delays in
completing or failure to complete studies if third parties fail to perform their obligations to us. If the results of our ongoing and planned studies for our drug candidates are not available when we expect or if we encounter any delay in the
analysis of the results of studies of our drug candidates:

 







  

we may not have the financial resources to continue research and development of any of our drug candidates;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

we may not be able to enter into collaborative arrangements relating to any drug candidate subject to delay in regulatory filing;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

we may lose any competitive advantage associated with early market entry; and

SIZE="1"> 







  

our ability to generate revenues may be delayed.

 

STYLE="margin-top:0px;margin-bottom:0px; text-indent:4%">Any of the following reasons, among others, could delay or suspend the completion of our ongoing and future studies:

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

delays in enrolling volunteers;

 







  

interruptions in the manufacturing of our drug candidates or other delays in the delivery of materials required for the conduct of our studies;

 







  

lower than anticipated retention rate of volunteers in a clinical trial;

SIZE="1"> 







  

unfavorable efficacy results;

 







  

serious side effects experienced by study participants relating to the drug candidate;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

failure to conduct a clinical trial in accordance with regulatory requirements or clinical protocols;

STYLE="margin-top:0px;margin-bottom:-6px"> 







  

inspection of a clinical trial operations or clinical trial site by regulatory authorities resulting in the imposition of a clinical hold;

 







  

new communications from regulatory agencies about how to conduct these studies; or

SIZE="1"> 







  

failure to raise additional funds resulting in lack of adequate funding to continue a clinical trial or study.

STYLE="margin-top:0px;margin-bottom:0px"> 


22








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