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Filing
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UNITED STATES 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
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 7, 2006
ADVENTRX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) |
1-15803 (Commission File No.) |
84-1318182 (IRS Employer Identification No.) |
6725 Mesa Ridge Road, Suite 100
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
N/A
(Former name or former address if changed since last report)
(Former name or former address if changed since last report)
Registrants telephone number, including area code: (858) 552-0866
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 7.01. Regulation FD Disclosure | ||||||||
Item 9.01. Financial Statements and Exhibits | ||||||||
SIGNATURE | ||||||||
INDEX TO EXHIBITS | ||||||||
EXHIBIT 99.1 |
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Item 7.01. Regulation FD Disclosure.
Evan M. Levine, Chief Executive Officer of Adventrx Pharmaceuticals, Inc. (Adventrx), will
present the information reflected in the slides attached as Exhibit 99.1 to this Current Report on
Form 8-K (this Report) on November 7, 2006 at the CIBC World Markets 17th Annual Healthcare
Conference at The Waldorf-Astoria Hotel in New York City. In addition, Mr. Levine will present the
information reflected in certain selected slides attached as Exhibit 99.1 to this Report on
November 7, 2006 at the Rodman and Renshaw 8th Annual Healthcare Conference at the Palace Hotel in
New York City.
The information in this Report, including the slides attached hereto as Exhibit 99.1, is being
furnished pursuant to this Item 7.01 and shall not be deemed filed for purposes of Section 18 of
the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of
that section, and it shall not be deemed incorporated by reference in any filing under the
Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof,
except as expressly set forth by specific reference in such filing to this Report.
By filing this Report and furnishing this information, Adventrx makes no admission as to the
materiality of any information in this Report. The information contained in the slides is summary
information that is intended to be considered in the context of Adventrx filings with the
Securities and Exchange Commission (the SEC) and other public announcements that Adventrx makes,
by press release or otherwise, from time to time. Adventrx undertakes no duty or obligation to
publicly update or revise the information contained in this Report, although it may do so from time
to time as its management believes is appropriate. Any such updating may be made through the filing
of other reports or documents with the SEC, through press releases or through other public
disclosure.
Adventrx cautions you that information included in the slides attached hereto as Exhibit 99.1 that
are not a description of historical facts are forward-looking statements that involve risks,
uncertainties, assumptions and other factors that, if they do not materialize or prove to be
accurate, could cause Adventrxs results to differ materially from historical results or those
expressed or implied by such forward-looking statements. Such forward-looking statements are made
based on managements current expectations and beliefs and should not be regarded as a statement or
representation by Adventrx that any of its plans, including its anticipated milestones, will be
achieved on time or at all. The potential risks and uncertainties that could cause actual results
to differ materially include, but are not limited to: the risk that Adventrx will be unable to
raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and
milestones; the potential to attract a strategic partner and the terms of any related transaction;
the ability to timely enroll subjects in Adventrxs current and anticipated clinical trials; the
results of pending clinical trials for CoFactor® or Adventrxs other product candidates; the
potential for CoFactor® and Adventrxs other product candidates to receive regulatory approval for
one or more indications on a timely basis or at all, and the uncertain process of seeking
regulatory approval; other difficulties or delays in developing, testing, manufacturing and
marketing of and obtaining regulatory approval for CoFactor® or Adventrxs other product
candidates; the market potential for fluoropyrimidine biomodulators and other target markets, and
Adventrxs ability to compete in those markets; unexpected adverse side effects or inadequate
therapeutic efficacy of CoFactor® or Adventrxs other
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products that could delay or prevent regulatory approval or commercialization, or that could result
in recalls or product liability claims; the risk that preclinical and clinical results are not
indicative of the success of subsequent clinical trials and that products will not perform as
preclinical and clinical data suggests or as otherwise anticipated; the potential for regulatory
authorities to require additional preclinical work or other clinical requirements to support
regulatory filings; the scope and validity of patent protection for CoFactor® and Adventrxs other
product candidates; and other risks and uncertainties more fully described in Adventrxs press
releases and periodic filings with the Securities and Exchange Commission. Adventrxs public
filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date when made. All forward-looking statements are qualified in their entirety by this
cautionary statement and Adventrx assumes no obligation to revise or update any forward-looking
statement, including any information included in the slides attached hereto as Exhibit 99.1, to
reflect events or circumstances arising after the date on which it was made. This caution is made
under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Index to
Exhibits filed with this report.
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SIGNATURE
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. |
||||
Dated: November 7, 2006 | By: | /s/ Evan M. Levine | ||
Name: | Evan M. Levine | |||
Title: | Chief Executive Officer | |||
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EXHIBIT 99.1
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0001.gif)
Click to edit Master title style Click to edit Master text styles Second level Third level Fourth level Fifth level ? ? 1 |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0002.gif)
Safe Harbor Statement ADVENTRX cautions you that information included in this presentation that is not a description of historical facts constitute forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX' results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such forward-looking statements are made based on management's current expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the potential to attract a strategic partner and the terms of any related transaction; the ability to timely enroll subjects in ADVENTRX' current and anticipated clinical trials; the potential for CoFactor(r) and ADVENTRX' other product candidates to receive regulatory approval for one or more indications on a timely basis or at all; the market potential for fluoropyrimidine biomodulators and other target markets; the risk that preclinical results are not indicative of the success of subsequent clinical trials; the scope and validity of patent protection for CoFactor(r) and ADVENTRX' other product candidates; and other risks and uncertainties more fully described in ADVENTRX' press releases and periodic filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement and ADVENTRX assumes no obligation to revise or update any forward-looking statement, including any information included in this presentation, to reflect events or circumstances arising after the date on which it was made. |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0003.gif)
Overview ADVENTRX Pharmaceuticals is focused on commercialization of low development risk pharmaceuticals for cancer and infectious disease that enhance the efficacy and/or safety of existing therapies. CoFactor? in registration trial Better safety profile Better efficacy Faster administration Addresses >$400M market ANX-530 (vinorelbine emulsion) entering registration trial in 2006 Multiple pipeline products planned to enter clinical trials in 2007 Investment Highlights: |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0004.gif)
ADVENTRX Pipeline PROGRAMS ONCOLOGY Vinorelbine (ANX-530)* Preclinical Ph I Pivotal Ph II Market ANTIBIOTICS Paclitaxel (ANX-513)* a-tocopherol succinate Docetaxel (ANX-514)* B-elemene Chitosan gel / OTC CoFactor (ANX-510) Thiovir (ANX-201) ANTI-VIRALS Selone Clarithromycin (ANX-015)* Anticipated 2007 progress Vancomycin (ANX-016)* NDA Current status * 505(b)(2) registration strategy |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0005.gif)
A new form of folate developed to replace leucovorin as the preferred biomodulator of 5-fluorouracil (5-FU) Lead Product: CoFactor CoFactor (MTHF), 495 Daltons Leucovorin Indicated for use with intravenous 5-FU in metastatic colorectal and other cancers and in methotrexate rescue Requires multiple metabolic steps to become the active form of folate CoFactor? Directly delivers the active form of folate CoFactor increases stability and improves binding of the 5-FU / thymidylate synthase (TS) complex Two clinical trials demonstrated greater 5-FU efficacy with reduced toxicity Clinical evidence indicates utility in gastrointestinal and breast cancers |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0006.gif)
Mechanism of Action CoFactor vs Leucovorin in 5-FU-Mediated Tumor Cell Death |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0007.gif)
Phase I/II CoFactor Trial CoFactor Phase I/II Study Design Clinical Design: Single Arm, Open Label Dosing Regimen: Dose escalating study using CoFactor (100 or 200mg) and 5-FU (4 doses: 250-600g/m2) IV bolus weekly Study Objectives: Assess safety, PK / PD, response rate, TTP and survival Study Population: 62 patients with breast, pancreatic, gastric, colorectal or gall bladder cancer Clinical Site: 1 (Goteborg, Sweden) Principal Investigator: Bengt Gustavsson, MD, PhD Phase I-II Study Of Weekly 5-Fluorouracil And 5,10-Methylene-Tetrahydrofolate In Patients With Advanced Gastrointestinal And Breast Cancer: G. Carlsson, E. Odin, P-A. Larsson, R. Frosing, C.P. Spears, B., Gustavsson: The Cancer Journal, Vol 10 No. 5 September-October 1997. |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0008.gif)
Bengt CF/5-FU 5-FU/LV n=407 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 29 14.5 9 21 22 11 14 % of patients Objective Response Rate Bengt CoFactor 5FU Ph II 5-FU/LV n=407 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 246 114 99 129 132 132 132 days Time to Tumor Progression Bengt CF/5-FU 5-FU/LV n=408 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 441 402 309 378 423 408 369 14.7 15.3 13.4 10.3 12.6 14.1 13.6 12.3 Survival days Phase I/II clinical results: Objective response in breast (56%), pancreatic (40%), gastric (33%) and colorectal (21%) cancers (1st + 2nd line) Greater response, TTP and overall survival compared historically to 5-FU plus LV treatment regimens (Graphs represent all first-line mCRC, n = 24 patients) Source: All comparison data are from 1st line mCRC trials from product package inserts or (UFT) from Douillard et al JCO Sept 2002, Carmichael et al JCO Sept 2002. CoFactor 1st line mCRC clinical trial Historical Comparison to 5-FU/LV Control Arms 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph I/II 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph I/II 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph I/II |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0009.gif)
Phase II CoFactor Trial CoFactor Phase II Study Design Clinical Design: Simon Two-Stage, Single Arm, Open Label Dosing Regimen: CoFactor 60mg/m2, 5-FU 450mg/m2 IV bolus, administered weekly for 6 weeks Primary Endpoint: > 25% objective tumor response (WHO criteria) Secondary Endpoints: Safety, TTP and overall survival Study Population: 50 patients enrolled, treatment naive metastatic CRC, prior adjuvant treatment permitted Clinical Sites: 9 (5 in USA and 4 in Serbia) Data Analysis: Blinded, third-party evaluations by CT scan or MRI Principal Investigator: Tony Reid, MD, PhD 5,10-methylenetetrahydrofolic acid with 5-fluorouracil as first line treatment in metastatic colorectal cancer: a phase II study. T. Reid, C. P. Spears, R. Quadro, M. Subramanian, L. Pawl, G. Jankovic, S. Jelic, N. Milinic, L Muzikravic, JM Robbins. 2006 Gastrointestinal Cancers Symposium, San Francisco. Jan-28, 2006 |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0010.gif)
Bengt CF/5-FU 5-FU/LV n=407 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 29 35 14.5 9 21 22 11 14 % of patients Objective Response Rate Bengt CoFactor 5FU Ph II 5-FU/LV n=407 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 246 162 114 99 129 132 132 132 days Time to Tumor Progression Bengt CF/5-FU 5-FU/LV n=408 5-FU/LV n=190 5-FU/LV n=226 5-FU/LV n=187 5FU/LV n=303 5FU/LV n=301 441 459 402 309 378 423 408 369 14.7 15.3 13.4 10.3 12.6 14.1 13.6 12.3 Survival days Phase II clinical results: Tumor response of 35% exceeds primary endpoint of 25% (n=46) Median TTP of 162 days (n=49) Median survival of 459 days (n=50) Excellent toxicity profile * Independently-determined Source: All comparison data are from 1st line mCRC trials from product package inserts or (UFT) from Douillard et al JCO Sept 2002, Carmichael et al JCO Sept 2002. CoFactor 1st line mCRC clinical trial Historical Comparison to 5-FU/LV Control Arms 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph II 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph II 2000 Irinotecan control arms 1999 UFT control arms n=303 2001 Xeloda? control arms n=301 n=226 n=187 n=407 n=190 CoFactor 5-FU Ph II |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0011.gif)
1st line Rx survival CF/5FU 23 27.4 90 20.4 Median Survival Following Second-line Therapy for mCRC months 33 patients went on to 2nd line treatment 4 patients underwent surgical resection Results compared to those from recent study comparing sequence of typical 1st/2nd line therapies Suggests CoFactor/5-FU would make a good initial mCRC treatment in a sequential treatment strategy Source: T. Reid, et al, 8th World Congress on GI Cancer June 28-July 1, 2006. Tournigand, TA, et al, J Clinical Oncology, 22:2, Jan 15, 2004, 229-237. Response to second line treatment Following CoFactor/5FU as first line treatment FOLFIRI CoFactor/5-FU n=33 n=109 FOLFOX6 n=111 Supplemental Phase II clinical results: 23.0 21.5 20.6 FOLFIRI FOLFOX6 Various 1st LINE: 2nd LINE: |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0012.gif)
Toxicity Profile Comparison (% Grades 3/4)* Grade 3-4 Adverse Events (%) Ph II 5-FU/ CoFactor n=50 5-FU/LV cntl arm Xeloda n=593 Xeloda n=596 5-FU/LV cntl arm UFT n=394 5-FU/LV cntl arm UFT n=185 5-FU/LV cntl arm CPT-11 n=226 5-FU/LV cntl arm CPT-11 n=187 Diarrhea 0 12 15 16 11 13 6 Nausea/Vomiting 0 7 8 10 9 12 6 Stomatitis/Mucositis 0 15 2 19 16 17 3 Abdominal pain 0 5 9 nr nr 12 1 Anemia 0 1 2 7 4 56 2 Neutropeniaa 2 21 3 56 31 67 13 Epiphora/Conjunctivitis 2 nr nr nr nr nr nr Hyperbilirubinemia 0 6 23 8 10 8 11 Alopecia 0 nr nr nr nr nr nr Fatigue 0 4 4 nr nr nr nr Weight loss 0 nr nr nr nr nr nr Neuropathy 0 nr nr nr nr nr nr Hand-Foot Syndrome 0 1 17 0 0 nr 1 *All comparison data from product package inserts or (UFT) from Douillard et al JCO Sept 2002, Carmichael et al JCO Sept 2002. Nausea/vomiting and stomatitis/mucositis were added if not given as combined. a Single case of Grade 4 neutropenia was reported during the 30 day follow up period after the last dose of CoFactor plus 5-FU study therapy and after the patient started FOLFOX with Avastin therapy |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0013.gif)
Toxicity Profile Comparison (% All Grades)* Adverse Events (% ALL grades) Ph II 5-FU/ CoFactor n=50 5-FU/LV cntl arm Xeloda n=593 Xeloda n=596 5-FU/LV cntl arm UFT n=394 5-FU/LV cntl arm UFT n=185 5-FU/LV cntl arm CPT-11 n=226 5-FU/LV cntl arm CPT-11 n=187 Diarrhea 42 61 55 76 60 69 45 Nausea/Vomiting 50 81 70 75 58 114 87 Stomatitis/Mucositis 10 62 25 75 55 76 29 Abdominal Pain 24 31 35 nr nr 50 17 Anemia 8 79 80 87 89 99 91 Neutropeniaa 6 46 13 77 67 99 48 Epiphora/Conjunctivitis 12 nr nr nr nr nr nr Hyperbilirubinemia 2 17 48 22 23 92 36 Alopecia 0 21 6 nr nr 27 17 Fatigue 28 46 42 nr nr nr nr Weight loss 10 nr nr nr nr nr nr Neuropathy 2 4 10 nr nr nr nr Hand-Foot Syndrome 4 6 54 5 4 nr 13 *All comparison data from product package inserts or (UFT) from Douillard et al JCO Sept 2002, Carmichael et al JCO Sept 2002. Nausea/vomiting and stomatitis/mucositis were added if not given as combined. a Single case of Grade 4 neutropenia was reported during the 30 day follow up period after the last dose of CoFactor plus 5-FU study therapy and after the patient started FOLFOX with Avastin therapy |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0014.gif)
CoFactor Preclinical Results Xenografts modeled in immunocompromised mice: Greater tumor inhibition Longer survival Cancer models tested colorectal (HT29, DLD-1) pancreatic (AsPC-1) gastric (HTB-135) Toxicity modeled in immunocompetent mice: Significantly lower hematological toxicity (reduced thrombocytopenia, leukopenia, neutropenia and lymphopenia) Significantly lower gastrointestinal toxicity (reduced weight loss) Replacing leucovorin with CoFactor led to longer survival and lower toxicity in regimens that included oxaliplatin, anti-VEGF, irinotecan, UFT, Xeloda and gemcitabine |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0015.gif)
CoFactor Clinical Development Plan Trial Indication Design 2007 2007 2008 2009 2009 EU/India Phase IIb 1st Line CRC CoFactor/5-FU versus LV/5-FU US Phase III 1st Line CRC CoFactor/ 5-FU/Avastin versus LV/5-FU/Avastin US Phase II Refractory breast CoFactor/5-FU Phase IIb Phase III Phase II |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0016.gif)
Phase IIb Europe/India mCRC Trial CoFactor Phase IIb Study Design Clinical Design: Multi-national randomized two-armed open-label Study Population: 1st line metastatic colorectal cancer Dosing Regimen: de Gramont regimen (400mg/m2 loading dose of 5-FU followed by 600 mg/m2 5-FU via 22 hr infusion for two consecutive days every 2 weeks), with either CoFactor 60mg/m2 or leucovorin 200 mg/m2, each administered every 2 weeks for 12 cycles as a 2 hr infusion. Primary Endpoint: Incidence of Grade 3 or 4 hematological or gastrointestinal toxicity Secondary Endpoints: Safety, response rate, TTP and survival Number of Patients: 300 (150 per arm) Clinical Sites: 30, Europe and India Data Analysis: Tumor assessment every 8 weeks, strict regulations for dose modification Study Chair: James Cassidy, MD, MBChB, MSc, FRCP |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0017.gif)
Phase III mCRC Trial CoFactor Phase III Pivotal Study Design Clinical Design: Multi-center, randomized, parallel group, open-label Study Population: 1st line metastatic colorectal cancer Dosing Regimen: * CoFactor 60mg/m2 by 2-3 min IV bolus. (Wait 20 min.) * leucovorin 500mg/m2 by 2 hour infusion. (Wait 1 hour) followed by 5-FU 500mg/m2 IV bolus administered weekly for 6 weeks. Avastin 5mg/kg continuous IV over 90 min. every 2 weeks Primary Endpoint: Improvement in progression-free survival of > 28 days; SPA with FDA Secondary Endpoints: Response rate, duration of response, overall survival and incidence and severity of AEs Number of Patients: 1200 pts (600 per arm) Clinical Sites: 100 planned, US Data Analysis: Tumor assessment every 8 weeks, strict regulations for dose modification. Power of 80%, ? level of 0.05. Estimated median TTP is 9.44 mo in control arm. Two interim analyses are planned. Principal Investigator: M. Wasif Saif, MD, MBBS |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0018.gif)
Phase II Breast Cancer Trial CoFactor Breast Cancer Study Design Clinical Design: Multi-center, open-label, single arm Study Population: Advanced breast cancer patients who failed anthracycline and taxane chemotherapy regimens Dosing Regimen: CoFactor 60mg/m2 by IV bolus followed by 5-FU 500mg/m2 IV bolus administered weekly for 6 weeks Primary Endpoint: Objective response rate (RECIST criteria) Secondary Endpoints: Duration of response, progression free survival, overall survival and incidence and severity of AEs Number of Patients: 31 pts Clinical Sites: 6 sites (Latin America, Europe, Russia) Study Assessments: Tumor and Safety assessments every 8 weeks Outcome to guide in design of Phase III study |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0019.gif)
Treatment Guidelines for Advanced or Metastatic CRC Source: NCCN Practice Guidelines in Oncology - v.2.2006; http://www.nccn.org/professionals/physician_gls/PDF/colon.pdf * Category 2B: There is nonuniform NCCN consensus based on lower-level evidence including clinical experience, that the recommendation is appropriate First-line Second-line Third-line FOLFOX + bevacizumab FOLFIRI + bevacizumab IFL + bevacizumab FOLFIRI or Irinotecan FOLFOX or Irinotecan + cetuximab Irinotecan or FOLFIRI FOLFOX: oxaliplatin, leucovorin, 5-FU FOLFIRI: irinotecan, leucovorin, 5-FU IFL: irinotecan, leucovorin, 5-FU Irinotecan + cetuximab Irinotecan +/- cetuximab 5-FU and LV are widely used in combination chemotherapy regimens for CRC or or or 5FU/LV + bevacizumab or CAPOX + bevacizumab* Irinotecan + cetuximab FOLFOX FOLFOX or Irinotecan or FOLFIRI Irinotecan Irinotecan + cetuximab CAPOX: capecitabine, oxaliplatin |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0020.gif)
5-FU Leucovorin Avastin Eloxatin Camptosar Xeloda Erbitux 83 68 3 47 1 17 1 West 30.6 38.6 34.6 31.6 North 45.9 46.9 45 43.9 5-FU Leucovorin Avastin Eloxatin Camptosar Xeloda Erbitux 61 60 54 29 42 17 17 West 30.6 38.6 34.6 31.6 North 45.9 46.9 45 43.9 Metastatic CRC: Drug Market Share* Source: Oncology, Inc. Adjuvant/Stage II & III: First Line: Second Line: patient share 5-FU LV Avastin Eloxatin Campto Xeloda Erbitux 5-FU Leucovorin Avastin Eloxatin Camptosar Xeloda Erbitux 75 73 62 54 20 19 3 West 30.6 38.6 34.6 31.6 North 45.9 46.9 45 43.9 patient share 5-FU LV Avastin Eloxatin Campto Xeloda Erbitux 5-FU LV Avastin Eloxatin Campto Xeloda Erbitux patient share *Based on most recent March 06 values |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0021.gif)
Leucovorin Market Global Market of >$480M for Leucovorin & Calcium Levofolinate (l-Lv) Source, IMS Health Quarterly volume ($M) Q1/05 Q2/05 Q3/05 Q4/05 Q1/06 Q2/06 Y 2005 LV + l-Lv 113.7 122.6 121.5 125 118.9 130.3 >480M LV 71.1 77.3 74.8 77.6 73.3 82.6 300.8M l-Lv 42.6 45.3 46.7 47.4 45.6 47.7 182M LV growing at >25% CAGR over last 3 years |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0022.gif)
A new formulation of intravenous vinorelbine tartrate designed to reduce vein irritation ANX-530 (emulsion formulation) FDA affirmation of single bioequivalency study as a marketing-enabling clinical trial Plan to assess vein irritation and additional safety parameters in human studies Reduced vein irritation in preclinical studies Pharmacokinetics and antitumor activity are similar to Navelbine in preclinical studies ANX-530 (vinorelbine emulsion) Vinorelbine (Navelbine?) Indicated as single agent or in combination with cisplatin for first line treatment of unresectable advanced NSCLC Injection site reactions in approximately one-third of patients |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0023.gif)
Vein Irritation Edema Erythema Normal vein, same as control vehicle More red than normal, slight vein thickening Dark red, 2-3mm vein thickening Dark blue/red, >3mm vein thickening Vein Irritation Score ANX-530 Ear vein toxicity 1st Injection 2nd Injection Navelbine? (vinorelbine) ANX-530 (vinorelbine emulsion) Lower vein irritation, edema and erythema in preclinical studies with ANX-530 |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0024.gif)
ANX-530 Ear vein histopathology Pharmacokinetics unchanged for vinorelbine emulsion Source: Cantwell, MJ, Robbins, JM, Chen, AX; A novel emulsion formulation of vinorelbine attenuates venous toxicity while maintaining antitumor efficacy; AACR 2006 Acute Hemorrhage Lympho/Granulocytic Infiltration Focal Epidermal Necrosis Perivascular Edema 0 to 3 scale - no observable event to marked severity. Toxicity scores represent the sum of all ear sections and rabbits in a dosing group (n=7 per group) ANX-530 Vinorelbine solution Favorable histopathology for ANX-530 in preclinical studies |
![](https://cdn.kscope.io/33d7d40b137005d147f53adcbf41e6e2-a24856a24856z0025.gif)
Vinorelbine Market MARKET SIZE GENERIC VINORELBINE SALES Global ~$160M Unit sales growth worldwide >10% each year Lung cancer is the second most common cancer in the US. Non-small cell lung represents 80-85% of all lung cancers. Five year overall survival is 10-15%. (Sources: NCI, ACS, IMS Health) * ANITA and NCIC CTG BR10 studies ASCO 2005 Lung cancer cases (US): 172,570 Deaths (US): 163,510 MARKET GROWTH OPPORTUNITY Potential for increased use in adjuvant setting; two landmark NSCLC studies demonstrated clear survival benefit (Winton et al and Douillard et al, ASCO 2005*) |
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ANX-513 (paclitaxel emulsion) A novel emulsion formulation of paclitaxel which is free of Cremophor, other detergents or macromolecules ANX-513 is designed to be non-allergenic and eliminate the need for immunosuppressant premedication No reactions were observed in a guinea pig hypersensitivity test with ANX-513 for high or low dose (standard hypersensitivity model) Taxane Emulsions ANX-514 (docetaxel emulsion) ANX-514 is a novel emulsion formulation of docetaxel free of polysorbate 80 or other detergents ANX-514 is intended to be non-allergenic and eliminate the need for multiday immunosuppressant premedication No reactions were observed in a guinea pig hypersensitivity test with ANX-514 for high or low dose (standard hypersensitivity model) |
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Total Taxane pharmaceutical market nearly $3 billion Taxanes Market *Source: EvaluatePharma Taxane Global Drug Sales 1999-2005* Docetaxel is approved to treat breast, non-small cell lung, prostate and gastric cancers Paclitaxel approved to treat breast, ovarian & non-small cell lung cancers |
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Thiovir (ANX-201) A broad spectrum antiviral and novel reverse transcriptase inhibitor to be used as a component of HAART for HIV/AIDS Synergistic with tenofovir (NRTI in Truvada? and Viread?) and zidovudine (NRTI in Combivir?, Trizivir?, Retrovir?) Demonstrates different resistance profile from multiple NRTIs and NNRTIs Foscarnet: Activity in HIV, HPV, herpes and influenza A Commercial limitations of foscarnet from delivery and toxicity Thiovir: Delivers TPFA, a prodrug for foscarnet (PFA) Thiovir (thiophosphonoformate, TPFA) |
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Thiovir Percent of NRTI-resistant Virus Susceptible to Drug % sensitivity % hypersensitive 3rd Qtr 4th Qtr TDF 0 90 20.4 ZDV 50 34.6 31.6 THV 83 17 45 43.9 TDF/d4T 16.66666667 ZDV 11.11111111 THV 17 83 TDF/d4T 30.76923077 ZDV 38.46153846 THV 31 69 TDF 0 ZDV 0 THV 100 TDF/d4T 100 ZDV 100 EFV 100 NVP 80 THV 60 40 % of viruses sensitive K65R n=2 TAMs n=18 M184V n=13 151 or 69 insert complexes n=6 Clinical mutation pattern Drug hypersensitive Source: Assays performed by Monogram Biosciences. Data on file. A virus is hypersensitive if it is more sensitive than a drug-sensitive standard (reference virus). DRUG KEY TDF tenofovir (Truvada?) ZDV zidovudine (Retrovir?) THV Thiovir d4T stavudine (Zerit?) EFV efavirenz (Sustiva?) NVP nevirapine (Viramune?) wild type n=5 TDF ZDV THV TDF/d4T ZDV THV TDF/d4T ZDV THV TDF ZDV THV ZDV THV TDF/d4T |
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Thiovir Percent of NNRTI-resistant Viruses Susceptible to Drug % sensitivity % hypersensitive 3rd Qtr 4th Qtr TDF 0 90 20.4 ZDV 50 34.6 31.6 THV 83 17 45 43.9 TDF/d4T 16.66666667 ZDV 11.11111111 THV 17 83 TDF/d4T 30.76923077 ZDV 38.46153846 THV 31 69 TDF 0 ZDV 0 THV 100 nnrti-resistant virus TDF/d4T 33.33333333 ZDV 37.03703704 EFV 3.703703704 NVP 14.81481481 THV 44 56 wt TDF/d4T 100 ZDV 100 EFV 100 NVP 80 THV 60 40 % of viruses sensitive Drug hypersensitive Source: Assays performed by Monogram Biosciences. Data on file. A virus is hypersensitive if it is more sensitive than a drug-sensitive standard (reference virus). DRUG KEY TDF tenofovir (Truvada?) ZDV zidovudine (Retrovir?) THV Thiovir d4T stavudine (Zerit?) EFV efavirenz (Sustiva?) NVP nevirapine (Viramune?) ZDV THV TDF/d4T EFV NVP ZDV THV TDF/d4T EFV NVP wild type n=5 NNRTI-resistant n=27 Virus |
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MARKET SIZE* RTI SALES (US) Drugs targeting HIV reverse transcriptase generate ~$4.9B in sales (2004) MARKET GROWTH HIV/AIDS is a chronic disease: Goal of treatment is lifelong viral suppression. Approximately 35% of the US HIV population receive treatment (300-400K patients) Number of HIV cases: US - 950,000 with 40,000 new cases each year North America and Western Europe - 1.8M Global - nearly 45M *Sources: National Center for Health Statistics (2003), SG Cowen, Oct 2004, Punk Ziegel and Co., Dec 05 NRTI PI NNRTI 3.2 1.7 0.9 30.6 38.6 34.6 45.9 46.9 45 Portion of total sales by drug class: HIV/AIDS Market |
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Indidence and prevalence database. Mintel International group. ANX-211 (Chitosan gel) Chitosan-based intranasal/topical broad spectrum antiviral intended to reduce duration and severity of cold and flu for OTC market ANX-211 demonstrated efficacy against viruses responsible for the common cold, influenza and other respiratory tract infections in preclinical studies US rights licensed to Theragenex (Oct 06): $1M licensing fee + milestones + up to 20% royalties on sales US market launch expected in 2007 Leading US product, Zicam(r), positioned for cold Annual expenditure in US for OTC products to fight cold, flu & allergy: No antiviral added (positive control) Zinc only preparation ANX-211 HEK cells infected by adenovirus carrying ?-gal gene. Virus-infected cells are blue from X-gal staining. ANX-211 was more effective than the zinc only preparation in protecting the cells against the adenovirus infection. US annual estimated # of cases1 influenza 20-50M common cold 500M Nearly $3B 2 ANX-211 Market |
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ANX-015 (clarithromycin emulsion) Clarithromycin for Injection Market: A novel IV-delivered emulsion formulation of the macrolide antibiotic, clarithromycin, designed to reduce vein irritation Klacid? (clarithromycin 500mg for injection, Abbott Laboratories) Global sales: >1.9M units Four Countries Make Up Two-thirds of the Global Clarithromycin IV Market (% of total unit sales) ANX-015 is designed to reduce injection site reactions characterized by phlebitis and inflammation that are common with IV clarithromycin Clarithromycin is highly potent against a variety of aerobic and anaerobic Gram- positive and Gram-negative organisms Source: IMS Health, 2005 |
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ANX-016 (vancomycin emulsion) ANX-016 is a novel emulsion IV formulation of the antibiotic, vancomycin designed to reduce vein irritation Growing need - US Statistics: 2M new hospital-acquired infections 90,000 deaths MRSA is an increasing problem MRSA Among ICU Patients 1995-2004 Sources: CDC, Merck Manual http://www.merck.com/mrkshared/mmanual/section13/chapter157/157a.jsp; incidence and prevalence database, www.emedicine.com, National Nosocomial Infections Surveillance (NNIS) System ANX-016 is designed to reduce vein irritation from IV-delivery of the drug. ANX-016 is intended for severe infections caused by susceptible strains of methicillin- resistant staphylococci (MRSA), penicillin-allergic patients and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. 3rd Qtr 4th Qtr US 116251 130772 90 20.4 JAPAN 110602 111210 34.6 31.6 FRANCE 77002 85918 45 43.9 UK 17022 17561 GERMANY 15680 16029 SPAIN 8390 9073 ITALY 7346 6175 Vancomycin IV: $375M Global Sales* *IMS Health, 2005 figures |
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Leadership Evan M. Levine, Chief Executive Officer, Director Former Principal Brown Simpson Asset Management; Senior VP Dillon Read; VP, Hambrecht & Quist James A. Merritt, M.D., President and Chief Medical Officer Imagine Pharmaceuticals, various senior positions at Introgen, Viagene, Idec Pharmaceuticals, Upjohn Joan M. Robbins, Ph.D., Chief Scientific Officer, Executive Vice President Former VP, Product Development, Immusol; R&D Scientist, Chiron; NCI/NIH Laboratory of Tumor Immunology & Biology Brian Culley, M.S., MBA, Senior VP, Business Development Former Director, Business Development and Marketing, Immusol, Inc., UCSD Technology Transfer and Intellectual Property Dept., Neurocrine Biosciences, Inc. Patrick Keran, General Counsel Isis Pharmaceuticals, Heller Ehrman, LLP, Brobeck, Phleger & Harrison, LLP. |
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Board of Directors M. Ross Johnson, Ph.D. Chairman Evan M. Levine Chief Executive Officer, ADVENTRX Mark Bagnall, C.P.A. Senior VP & Chief Business Officer, Metabolex, Inc. Alex Denner, Ph.D. Icahn Partners LP, Icahn Partners Master Fund LP. ImClone Systems BOD Michael M. Goldberg, M.D. Chairman and CEO, Emisphere Technologies, Inc. Jack Lief President, CEO and Director, Arena Pharmaceuticals Mark J. Pykett, V.M.D., Ph.D. President and COO, Boston Life Sciences, Inc., Cofounder, Cytomatrix |
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Summary CoFactor? in registration trial Better safety profile Better efficacy Faster administration Addresses >$400M market ANX-530 (vinorelbine emulsion) entering registration trial in 2006 Multiple pipeline products planned to enter clinical trials in 2007 Investment Highlights: |
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