-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, TPhNsjqvURdngWB+2LeMUbaB7O7aNmYz7lISdsILaY3GJdE1xYUo0jKTduyH7MCk qFrI01bLYDoY/OPL4JQLRA== 0001193125-05-173006.txt : 20050823 0001193125-05-173006.hdr.sgml : 20050823 20050823132621 ACCESSION NUMBER: 0001193125-05-173006 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050822 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050823 DATE AS OF CHANGE: 20050823 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PANACOS PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001040017 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 113238476 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24241 FILM NUMBER: 051043204 BUSINESS ADDRESS: STREET 1: 134 COOLIDGE AVE CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 617-926-1551 MAIL ADDRESS: STREET 1: 134 COOLIDGE AVE CITY: WATERTOWN STATE: MA ZIP: 02472 FORMER COMPANY: FORMER CONFORMED NAME: V I TECHNOLOGIES INC DATE OF NAME CHANGE: 19980209 8-K 1 d8k.htm FORM 8-K Form 8-K

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

 

Date of Report (Date of earliest event reported): August 22, 2005

 


 

PANACOS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   0-24241   11-3238476

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

134 Coolidge Avenue

Watertown, Massachusetts 02472

(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (617) 926-1551

 


 

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 (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



ITEM 8.01 OTHER EVENTS

 

On August 22, 2005, Panacos Pharmaceuticals, Inc. (“Panacos” or the “Company”) announced that it had successfully completed the Phase 2a clinical study of its lead HIV drug candidate, PA-457, and provided preliminary analysis of the results. The study met its primary endpoint by demonstrating a statistically significant reduction in the level of HIV in the blood, known as viral load, compared to placebo. The median reduction in viral load in the trial was greater than 1 log10, or a 90% decrease, at the highest dose. PA-457 is the first in a new class of HIV drugs called Maturation Inhibitors, with broad activity against HIV, including strains resistant to currently approved drugs, the most common cause of HIV treatment failure.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

 

(c) Exhibits:

 

  99.1 Press Release of Panacos Pharmaceuticals, Inc. dated August 22, 2005


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.

 

    PANACOS PHARMACEUTICALS, INC.
Dated: August 23, 2005        
    By:  

/s/ Peyton Marshall


        Peyton Marshall
        Executive Vice President and
        Chief Financial Officer


EXHIBIT INDEX

 

Exhibit No.

 

Description


99.1   Press Release of Panacos Pharmaceuticals, Inc. dated August 22, 2005.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

CONTACT:

 

Peyton Marshall

Executive Vice President & CFO

617-926-1551

pmarshall@panacos.com

 

Panacos Drug Candidate PA-457 Shows Potent Antiviral Activity in HIV-infected Patients

 

Viral Load Reduction Meets Primary Endpoint of Phase 2a Study

 

Watertown, MA (August 22, 2005) – Panacos Pharmaceuticals, Inc. (Nasdaq: PANC) (“Panacos” or “the Company”), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced the successful completion of a Phase 2a clinical study of its lead HIV drug candidate, PA-457, and provided preliminary analysis of the results. The study met its primary endpoint by demonstrating a statistically significant reduction in the level of HIV in the blood, known as viral load, compared to placebo. The median reduction in viral load in the trial was greater than 1 log10, or a 90% decrease, at the highest dose. PA-457 is the first in a new class of HIV drugs called Maturation Inhibitors, with broad activity against HIV, including strains resistant to currently approved drugs, the most common cause of HIV treatment failure.

 

In this randomized double-blind Phase 2a study, performed at leading academic centers in the US, PA-457 at one of four doses (25, 50, 100 or 200mg; 6 patients per group) or placebo (8 patients), was administered orally once daily for 10 days to HIV-infected subjects not on other antiretroviral therapy. The primary endpoint was viral load reduction on Day 11. Other endpoints included safety, tolerability and pharmacokinetics of the drug.

 

At the 100 and 200 mg doses, PA-457 treatment for 10 days resulted in statistically significant reductions in viral load compared to placebo, with individual decreases of up to 1.7 log10. At the 200mg dose level, the median viral load change at Day 11 was -1.03 log10. Median Day 11 values at the other dose levels were: Placebo:

 

+0.03 log10; 25mg: +0.05 log10; 50mg: - -0.17 log10; 100mg: -0.48 log10. In patients with baseline viral loads under 100,000 copies/ml the median Day 11 reduction was -1.52 log10 at the 200mg dose level (three of six patients) and -0.56 log10 at the 100mg dose level (five of six patients).


Panacos Drug Candidate PA-457 Shows Potent Antiviral Activity in HIV-infected Patients —

Page 2

 

Genetic analysis of HIV in patients pre- and post- treatment, available now for 21 out of 33 patients in the study, showed no evidence of the development of resistance to PA-457, the same result as seen previously in a single dose study with PA-457. All doses were observed to be generally safe and well tolerated with no Grade 3 or 4 laboratory abnormalities. All adverse experiences were mild or moderate and no dose-limiting toxicity was identified. One moderate adverse event was classified as possibly related to drug and was categorized as serious based on the subject’s hospitalization for diagnostic tests. It involved a patient with a 5-year history of poorly controlled hypertension who exhibited transient findings of a possible lacunar cerebrovascular accident, a known complication of hypertension.

 

Graham P. Allaway Ph.D., Chief Operating Officer of Panacos, said: “This study indicates that PA-457 has potent anti-HIV activity, providing further clinical proof of principle for this new class of antiretroviral drugs. The overall viral load reduction at the 200mg dose of over 1 log10 strongly supports further development of PA-457. The 1.5 log10 viral load reduction seen in patients at the 200mg dose with less than 100,000 viral copies/ml may potentially reflect the potency of the drug when used in combination therapy in normal clinical practice.” Panacos is submitting the results of this study as a late breaker abstract to the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held in New Orleans, LA September 21-24, 2005. If accepted, a detailed description of the study will be provided at that conference.

 

“We are extremely pleased with the results of this important Phase 2a study,” commented Samuel K. Ackerman, MD, Chairman and CEO of Panacos. “We believe that PA-457 is a potential breakthrough drug which could play a role throughout the HIV treatment spectrum, including both naïve and treatment-experienced patients, based on once-a-day oral dosing, potent activity observed against drug resistant virus and a promising safety profile. We now plan to move forward aggressively to initiate a Phase 2b study of the drug in the first half of 2006.”


Panacos Drug Candidate PA-457 Shows Potent Antiviral Activity in HIV-infected Patients —

Page 3

 

About PA-457

 

PA-457 is a small molecule, oral HIV drug candidate. It works by a mechanism different from that of approved drugs or other drugs in development, by blocking a key step in the processing of a viral core protein called capsid. This novel mechanism of action, called maturation inhibition, was discovered by Panacos scientists and their collaborators. Preclinical studies have shown that PA-457 retains full activity against drug-resistant virus, is effective in an animal model of HIV infection and should be suitable for use in combination therapy with other drugs. A previous clinical study indicated that a single oral dose of PA-457 has antiviral activity in HIV-infected patients, including individuals infected with drug resistant strains. Clinical results to date will need to be confirmed and extended in longer term trials with larger patient numbers prior to approval.

 

The US Food and Drug Administration (FDA) has granted Fast Track designation to PA-457. Fast Track is a process designed to expedite development and approval of new drugs that may have the potential to improve treatment for serious or life-threatening diseases. Developers of Fast Tracked products have greater access to FDA resources as well as eligibility for rolling NDA submissions. In addition, Fast Track designation may enable priority FDA review and accelerated approval.

 

About Panacos Pharmaceuticals

 

Panacos, formerly known as V. I. Technologies, Inc. or VITEX, is developing the next generation of anti-infective products through discovery and development of small molecule oral drugs for the treatment of HIV and other major human viral diseases. Panacos’ proprietary discovery technologies and lead therapeutic candidate PA-457 focus on novel targets in the virus life cycle, including virus fusion and virus maturation. For more information on Panacos, please visit our web site at: http://www.panacos.com.

 

Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, such as the progress of clinical development of PA-457, including the Company’s plan to initiate a Phase 2b study in the first half of 2006, and the timing of results of clinical trials, the execution of the Company’s financing plans, the potential role of PA-457 in treatment of HIV patients, the timely availability of new products, market acceptance of the Company’s products, the impacts of competitive products and pricing, government regulation of the Company’s products, the Company’s ability to complete product development collaborations and other strategic transactions and other risks and uncertainties set forth in the Company’s filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

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