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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) June 28, 2006
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
|
1-15803 | 84-1318182 | ||
(State or other jurisdiction of
|
(Commission File Number) | (IRS Employer | ||
incorporation)
|
Identification No.) |
6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(858) 552-0866
(Company’s telephone number, including area code)
(Company’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
| Item 8.01. Other Events | ||||||||
| Item 9.01. Financial Statements and Exhibits. | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT INDEX | ||||||||
| EXHIBIT 99.1 | ||||||||
| EXHIBIT 99.2 | ||||||||
| EXHIBIT 99.3 | ||||||||
Table of Contents
Item 8.01. Other Events
On June 28, 2006 the Company announced the initiation of its Phase III pivotal clinical trial
for CoFactorâ in metastatic colorectal cancer.
On
June 29, 2006, the Company announced that it had presented encouraging new supplemental
results from its CoFactor Phase II metastatic colorectal cancer trial at the 8th World Congress on
Gastrointestinal Cancer in Barcelona, Spain.
On
June 29, 2006, the Company announced that it had presented CoFactor pharmacokinetics data
at the 8th World Congress on Gastrointestinal Cancer in Barcelona, Spain.
The
press releases issued by the company on June 28 and 29, 2006 with
respect to these matters are included with this report as exhibits.
Item 9.01. Financial Statements and Exhibits.
| (d) | The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report. |
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ADVENTRX Pharmaceuticals, Inc. | ||||||
| By: | /s/ Carrie E. Carlander | |||||
| Name: | Carrie E. Carlander | |||||
| Title: | Chief Financial Officer, Senior VP Finance,
Secretary & Treasurer June 30, 2006 |
|||||
Table of Contents
EXHIBIT INDEX
| Exhibit | Description | |
99.1
|
Press Release of the Company dated June 28, 2006 re. Initiation of Phase III Clinical Trial in Metastatic Colorectal Cancer | |
99.2
|
Press Release of the Company dated June 29, 2006 re. Presentation of Supplemental Results for the CoFactor Phase II Trial at the 8th World Congress on Gastrointestinal Cancer in Barcelona, Spain. | |
99.3
|
Press Release of the Company dated June 29, 2006 re. Presentation of CoFactor Pharmacokinetics Data at the 8th World Congress on Gastrointestinal Cancer in Barcelona, Spain. |
Exhibit 99.1
ADVENTRX INITIATES COFACTOR PHASE III CLINICAL TRIAL
SAN DIEGO — June 28, 2006 — ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced the
initiation of its Phase III pivotal clinical trial for CoFactorâ in metastatic colorectal
cancer.
This randomized, controlled clinical trial builds on the promising results of earlier studies, to
fully investigate the efficacy and safety of CoFactor for patients with first line metastatic
colorectal cancer.
Patient eligibility screening for this pivotal trial has begun at several clinical sites. A total
of 100 clinical sites in the US are planned for the Phase III study, following institutional review
board (IRB) approval of the clinical protocol, credentialing of the investigational team and an
on-site inspection and procedural review by the Company prior to drug shipment to the site
pharmacy.
“The initiation of this Phase III pivotal clinical trial for CoFactor in metastatic colorectal
cancer represents an important milestone for our lead product development program and our business
as a whole,” said Evan M. Levine, president and CEO for ADVENTRX. “We are very encouraged by the
efficacy and safety data we have seen to date from the CoFactor Phase II trial, which has surpassed
most historical 5-fluorouracil plus leucovorin efficacy and safety results from multi-institutional
studies.”
CoFactor is being developed to improve the efficacy and safety of the widely used chemotherapeutic
drug, 5-fluorouracil (5-FU).
About the Phase III clinical trial
The Phase III clinical trial is a multicenter, 1200 patient, controlled study in first-line treatment of patients with metastatic colorectal cancer. Patients will be equally randomized to two arms containing either CoFactor or leucovorin, each in combination with 5-FU and bevacizumab (Avastinâ). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events. The protocol and planned analysis were accepted by the FDA under a Special Protocol Assessment. M. Wasif Saif, MD, MBBS, Associate Professor of Yale University School of Medicine is the national principal investigator. A total of 100 clinical sites in the US are planned for the Phase III study.
The Phase III clinical trial is a multicenter, 1200 patient, controlled study in first-line treatment of patients with metastatic colorectal cancer. Patients will be equally randomized to two arms containing either CoFactor or leucovorin, each in combination with 5-FU and bevacizumab (Avastinâ). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events. The protocol and planned analysis were accepted by the FDA under a Special Protocol Assessment. M. Wasif Saif, MD, MBBS, Associate Professor of Yale University School of Medicine is the national principal investigator. A total of 100 clinical sites in the US are planned for the Phase III study.
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that determined an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported preliminary median overall survival of 459 days, median time to tumor progression (TTP) of 162 days, and no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity in this Phase II clinical trial.
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that determined an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported preliminary median overall survival of 459 days, median time to tumor progression (TTP) of 162 days, and no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity in this Phase II clinical trial.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
Forward-Looking Statement
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
# # #
Exhibit 99.2
ADVENTRX PRESENTS ENCOURAGING NEW SUPPLEMENTAL RESULTS FOR THE COFACTOR
PHASE II METASTATIC COLORECTAL CANCER TRIAL
PHASE II METASTATIC COLORECTAL CANCER TRIAL
SAN DIEGO — June 29, 2006 — ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today
encouraging results from a follow-up evaluation of the 50 patients who completed the
CoFactorâ plus 5-fluorouracil (5-FU) Phase II clinical trial. The new information captures
clinical responses to second line therapies for their metastatic colorectal cancer that were
selected by the investigators. The ADVENTRX protocol mandated only first line treatment and long
term follow-up monitoring, but did not guide in any way the selection or use of subsequent therapy.
The results were presented as abstract number 620, entitled “Response to second line treatment
following 5,10-methylenetetrahydrofolic acid (CoFactor) with 5-fluorouracil as first line treatment
in metastatic colorectal cancer” at the 8th World Congress on Gastrointestinal Cancer in Barcelona,
Spain.
Fifty patients completed CoFactor plus 5-FU treatment in a Phase II clinical trial and were
followed for second line therapy. Four underwent partial liver resection for potential cure and 29
patients received chemotherapy with irinotecan or oxaliplatin, alone or in combination with
5-FU/leucovorin, as well as other agents. Seventeen patients received no post-study intervention.
Of the 29 patients who received post-study chemotherapy, four patients (13.8 percent) had an
objective response, including one complete response. Median overall survival, measured from the
initiation of first line treatment, was 15.1 months for the whole population and was 23.0 months
for the 33 patients that received second line treatment, which includes the four patients who
underwent surgical resection.
“We observed a highly respectable objective response rate to second line chemotherapies. This
reflects the use of active regimens that are still available to patients who commence therapy with
5-FU and CoFactor. Most encouraging is the overall survival of 23 months observed in patients
completing first and second line therapy which exceeds by two months the median survival reported
(Tournigand et al, JCO, 22:2, Jan 15, 2004) in patients commencing with either FOLFOX or FOLFIRI,”
commented James A. Merritt, MD, chief medical advisor for ADVENTRX. “While it is important to
emphasize that these data are preliminary, they suggest CoFactor plus 5-FU may be a useful initial
regimen in a sequential treatment strategy for metastatic colorectal cancer.”
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that found an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported median time to tumor progression (TTP) of 162 days, preliminary median overall survival of 459 days with no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity. A Phase IIb clinical trial is ongoing in Europe and India. In addition, the Company initiated a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer in the U.S. in the second quarter of 2006.
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that found an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported median time to tumor progression (TTP) of 162 days, preliminary median overall survival of 459 days with no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity. A Phase IIb clinical trial is ongoing in Europe and India. In addition, the Company initiated a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer in the U.S. in the second quarter of 2006.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
Forward Looking Statement
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
# # #
Exhibit 99.3
ADVENTRX PRESENTS COFACTOR PHARMACOKINETICS DATA
SAN DIEGO — June 29, 2006 — ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that it
presented pharmacokinetics data from a study conducted to characterize the levels of
CoFactorâ in the body before, during and following a two hour infusion. The study found that
peak plasma levels of drug from a two hour infusion of 60mg/m2 CoFactor were similar to
bolus administration and should be sufficient for biological effect. The results support the use of
a two hour administration of 60mg/m2 CoFactor with infusional regimens of 5-fluorouracil
(5-FU). A Phase IIb clinical trial is ongoing using CoFactor plus 5-FU in an infusional regimen for
first line treatment of metastatic colorectal cancer.
“This PK study demonstrates that we can achieve significant plasma concentrations of CoFactor from
a two hour administration, suggesting that CoFactor would be suitable in an infusional regimen, the
standard 5-FU administration for metastatic colorectal cancer in Europe,” said Joan M. Robbins,
Ph.D., chief scientific officer and executive vice president for ADVENTRX.
The abstract entitled “Pharmacokinetics of 5,10-methylenetetrahydrofolate (CoFactor) administered
as a 2-hour infusion” (abstract number 623) was presented at the 8th World Congress on
Gastrointestinal Cancer. The conference takes place June 28—July 1, 2006 in Barcelona, Spain.
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that found an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported median time to tumor progression (TTP) of 162 days, preliminary median overall survival of 459 days with no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity. The Company initiated a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer in the U.S. in the second quarter of 2006.
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that found an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported median time to tumor progression (TTP) of 162 days, preliminary median overall survival of 459 days with no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity. The Company initiated a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer in the U.S. in the second quarter of 2006.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. More information can be found on the Company’s Web site at www.adventrx.com.
Forward Looking Statement
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
This press release contains forward-looking statements, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on management’s current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements regarding ADVENTRX, see the section titled “Risk Factors” in ADVENTRX’s last annual report on Form 10-K and its Quarterly Reports on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
# # #
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