| |
Panacos Pharmaceuticals Announces Initiation of Phase 2 Clinical Development of its HIV Drug Candidate, PA-457
|
| |
| |
GAITHERSBURG, MD, December 10, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced the initiation of a Phase 2a clinical trial of PA-457, the first in a new class of HIV drug candidates called Maturation Inhibitors. Institutional Review Board (IRB) and other approvals have been received and the study is now open for enrollment. Panacos plans to complete dosing of all patients during Q1, 05.
The study, to be performed at several sites in the U.S., is designed to demonstrate the antiviral potency of PA-457 following once-daily oral dosing for 10 days in HIV-infected patients who are not on other antiretroviral therapy. Panacos recently announced positive results from a Phase I/II clinical trial in HIV-infected patients. Following a single oral dose of PA-457, a significant reduction in viral load from baseline, of up to approximately 0.7 log10, was seen in patients receiving the higher dose levels. The Company also recently completed a Phase Ib clinical trial of PA-457 administered orally once a day for 10 days to uninfected volunteers. The drug candidate was well tolerated and plasma concentrations of PA-457 reached levels significantly greater than those predicted to provide a therapeutic benefit in HIV-infected patients. Both of those studies have been selected for presentation at the 12th Conference on Retroviruses and Opportunistic Infections to be held in Boston, MA during February, 2005.
"Initiation of Phase 2 development of PA-457 is a major milestone for the Company," commented Dr. David E. Martin, VP, Drug Development at Panacos. "This study builds on our recent rapid progress, generating encouraging safety and pharmacokinetic data from the Phase Ib study and demonstrating a reduction in viral load following a single oral dose in HIV-infected patients in the Phase I/II study. PA-457 has a long half-life in the body, resulting in significantly increased plasma concentrations following repetitive daily dosing. Therefore, we expect to see an even greater viral load reduction when PA-457 is administered on a daily basis for several days or more." Results of the Phase 2a clinical trial are expected in Q2, 2005. During the second half of 2005, Panacos intends to initiate Phase 2b studies of PA-457 designed to pave the way for pivotal Phase 3 studies.
PA-457 is the first in a new class of oral HIV drugs discovered by Panacos scientists that inhibit virus maturation, the last stage of the virus life cycle. It is designed to combat drug resistance, which occurs in most HIV patients treated with currently available drugs and is the leading cause of treatment failure. PA-457 works by a mechanism different from that of any approved drug or other drug in development, by blocking a key step in the processing of a viral core protein called capsid. 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.
Panacos Pharmaceuticals' HIV Drug Candidate, PA-457, Exhibits Potent Anti-HIV Activity Following a Single Dose in HIV-Infected Patients
Full Results to be Presented at the 12th Conference on Retroviruses and Opportunistic Infections, February 2005
GAITHERSBURG, MD, November 23, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced positive preliminary results from a proof-of-principle Phase I/II clinical trial of the Company's lead HIV drug candidate, PA-457. In that study, PA-457 was administered as a single oral dose to HIV-infected patients who were not on other therapy, in order to determine the pharmacokinetics and antiviral effect of the compound. Several different dose levels were tested in addition to placebo and the level of virus in the plasma, known as the viral load, was measured before and at intervals after treatment in each patient. A significant reduction in viral load, of up to approximately 0.7 log10, was seen in patients receiving the higher dose levels.
The study has been selected for oral presentation at the 12th Conference on Retroviruses and Opportunistic Infections to be held in Boston, MA during February, 2005, at which time a detailed description of the clinical trial and results will be provided. The Company will also present data from a recently completed Phase Ib clinical trial of PA-457 at the Conference. In that trial, PA-457 was administered orally once a day for 10 days to uninfected volunteers. PA-457 was well tolerated and plasma concentrations of the compound reached levels significantly greater than those predicted to provide a therapeutic benefit in HIV-infected patients.
Dr. David E. Martin, Panacos' VP, Drug Development, commented: "The results of the proof-of-principle study in HIV-infected patients are extremely encouraging and provide strong validation for PA-457's further development. A reduction of up to 0.7 log10 in HIV RNA following just a single dose should translate into a much greater antiviral effect when PA-457 is administered on a daily basis for several days or more."
PA-457 is the first in a new class of oral HIV drugs discovered by Panacos scientists that inhibit virus maturation, the last stage of the virus life cycle. It is designed to combat drug resistance, which occurs in most HIV patients treated with currently available drugs. Resistance to existing drugs is the most pressing problem in HIV therapy and the leading cause of treatment failure. PA-457 works by a mechanism completely different from that of any approved drug or other drug in development, by blocking a key step in the processing of a viral core protein called capsid. 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.
The Company is about to initiate a key multiple dose Phase IIa study in HIV-infected patients with results expected in the first half of 2005. This study is designed to determine the antiviral effect of multiple once-daily doses of PA-457 in patients who are not on other antiretroviral therapy.
About Panacos
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule oral drugs for the treatment of HIV and other major human viral diseases. Panacos' proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection.
On June 2, 2004, Panacos Pharmaceuticals entered into a definitive merger agreement with V.I. Technologies, Inc. (Nasdaq: VITX), a biotechnology company dedicated to developing novel anti-infective technologies. The terms of the merger were amended on November 8, 2004. The transaction is expected to close in the first quarter of 2005 and is subject to the approval by shareholders of both companies and other customary closing conditions.
PA-457 HIV Drug Gets Fast-Track Status From FDA
January 06, 2005
GAITHERSBURG Md. (Dow Jones)--Privately held Panacos Pharmaceuticals Inc., which is in the process of merging with V.I. Technologies Inc. (VITX), received fast-track status from the Food and Drug Administration for PA-457, the company's HIV drug.
Fast-track status is designed to expedite development and approval of new drugs that may have the potential to improve treatment for serious or life-threatening diseases.
In premarket trading Thursday, shares of V.I. Technologies were quoted at $1.27, according to Inet. The company's stock closed at 69 cents Wednesday.
In a press release Thursday, Panacos said it intends to initiate phase IIb studies of PA-457 during the second half of 2005, paving the way for phase III studies beginning in 2006.
Panacos has completed phase Ia and phase Ib studies of PA-457 in uninfected volunteers, demonstrating that the drug is well tolerated with pharmacokinetics supporting once-daily oral dosing.
The company recently announced positive results from a proof-of-concept phase I/II clinical trial of PA-457 in HIV-infected patients.
Panacos will provide full results of the phase Ib and phase I/II clinical trials in February.
Meanwhile, in December, Panacos initiated a phase IIa clinical trial of PA-457. The study, being performed at multiple sites in the U.S., is designed to evaluate the antiviral potency of PA-457 following once-daily oral dosing for 10 days, in HIV-infected patients who are not on other antiretroviral therapy.
Panacos expects results of the Phase IIa clinical trial in the second quarter.
Panacos agreed to merge with V.I. Technologies, which develops anti-infective products, in June 2004. The terms of the merger have been amended several times, though the transaction is expected to close in the first quarter of this year, subject to shareholder approval.
Panacos Pharmaceuticals Initiates Phase 1 Clinical Trial of PA-457, the First in a New Class of Oral Anti-HIV Compounds
GAITHERSBURG, MD, March 16, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced that it has begun a Phase 1 clinical trial of its small molecule HIV drug candidate PA-457. PA-457 has a different mechanism of action than approved HIV drugs and has potent activity against HIV strains resistant to current therapies, including inhibitors of reverse transcriptase and viral protease. In the Phase 1 trial, PA-457 is being administered orally to uninfected, healthy volunteers to evaluate the compound's safety and pharmacokinetics
Graham Allaway, Ph.D., Panacos' Chief Operating Officer, commented: "The initiation of our first clinical trial is a key milestone for Panacos. More importantly, PA-457 represents a milestone for HIV drug discovery, being the first in the new class of antiretrovirals called Maturation Inhibitors that offer the promise of new treatment options for patients with HIV. Following successful completion of Phase 1, we plan to begin testing PA-457's antiviral potency in HIV-infected individuals later this year."
In recent years, there has been a dramatic increase in the prevalence of HIV strains resistant to currently approved drugs. This often leads to treatment failure, so there is a critical need for new therapies that are effective against drug-resistant HIV strains. Panacos is developing drugs with novel mechanisms of action, like PA-457, that may have broad utility for treating HIV infected patients including those harboring drug-resistant strains. PA-457 interferes with HIV maturation, a key step in viral replication that occurs as new virus particles are released from infected cells. Pre-clinical studies on PA-457 demonstrated that the compound has favorable pharmacokinetics and anti-HIV activity in animals following oral administration and suggest it should be possible to achieve therapeutic drug concentrations following oral delivery in humans.
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule, orally available drugs for the treatment of HIV and other major human viral diseases. The Company's proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection.
For more information on Panacos Pharmaceuticals, please visit our website: http://www.panacos.com, or contact us by email: info@panacos.com.
Panacos Pharmaceuticals Completes Single Dose Phase 1 Clinical Trial of PA-457 and Initiates Multiple Dose Study of this First-in-Class HIV Maturation Inhibitor
GAITHERSBURG, MD, June 1, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced that it has successfully completed a single, escalating dose Phase 1 clinical trial of the first-in-class HIV Maturation Inhibitor, PA-457. Following oral administration to uninfected, healthy volunteers, PA-457 was well tolerated and exhibited favorable oral bioavailability and pharmacokinetics. A detailed update on PA-457 will be made in July at the XV International AIDS Conference in Bangkok, Thailand.
Based on the promising results of the first clinical study, Panacos has now progressed the compound into a multiple dose Phase 1 study to examine the safety and pharmacokinetics of PA-457 administered once daily to uninfected, healthy volunteers for 10 days. Dr. David E. Martin, VP, Drug Development at Panacos commented: "We are very pleased that the results of our first human study with PA-457 strongly support the continued development of this novel oral HIV inhibitor. Following successful completion of the multiple dose Phase 1 study, we will move PA-457 into Phase 2 testing in HIV-infected patients later this year."
PA-457 has a mechanism of action that is different from approved HIV drugs and as a result exhibits potent activity against HIV strains resistant to current therapies including inhibitors of reverse transcriptase and viral protease. In recent years, there has been a dramatic increase in the prevalence of HIV strains resistant to currently approved drugs. This often leads to treatment failure, so there is a critical need for new therapies that are effective against drug-resistant HIV strains. PA-457 interferes with HIV maturation, a key step in viral replication that occurs as new virus particles are released from infected cells. PA-457's novel target was discovered by Panacos scientists and their collaborators at the National Institutes of Health, as described in a major publication in November, 2003 (Proceedings of the National Academy of Sciences of the USA vol. 100, pp. 13555-13560). In addition to its antiviral potency in vitro, recent studies have demonstrated that PA-457 has significant antiviral activity in vivo, using the SCID mouse model of HIV infection.
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule, orally available drugs for the treatment of HIV and other major human viral diseases. The Company's proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection.
Panacos Pharmaceuticals Presents Data on HIV Maturation Inhibitor PA-457 at 13th International Symposium on HIV & Emerging Infectious Diseases
GAITHERSBURG, MD, June 4, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today presents its latest findings on the mechanism of action of PA-457, the Company's lead HIV drug candidate, which is the first in a new class of oral antiretroviral drugs called Maturation Inhibitors. In an invited presentation at the 13th International Symposium on HIV & Emerging Infectious Diseases in Toulon, France, the Company provides an update on PA-457, including progress in understanding the compound's viral target.
Carl Wild, Ph.D., Panacos' Chief Science Officer and speaker at the conference said: "PA-457 potently inhibits HIV replication by specifically blocking a late step in processing of the viral Gag protein, namely conversion of the capsid precursor to mature capsid protein. As a result, newly released viral particles are defective and non-infectious. Consistent with this novel mechanism of action, PA-457 retains activity against virus isolates resistant to the currently approved classes of HIV therapeutics including reverse transcriptase inhibitors and protease inhibitors."
At the conference, Dr. Wild discusses recent experiments designed to further elucidate PA-457's molecular target. These studies demonstrated that the determinants of PA-457 activity reside in specific amino acid residues in the HIV Gag protein that flank the cleavage site between the capsid protein and a linker protein called SP1, thus helping to explain how PA-457 inhibits the formation of mature capsid protein. The new results allow Panacos to continue building a strong proprietary position around the PA-457 target, which forms the basis for the Company's maturation inhibitor discovery platform.
Panacos recently completed the first human clinical trial of PA-457. Following single dose oral administration to uninfected, healthy volunteers, PA-457 was well tolerated and exhibited favorable oral bioavailability and pharmacokinetics. Based on these promising results, Panacos has now progressed the compound into a multiple dose Phase 1 study to examine the safety and pharmacokinetics of PA-457 when administered as a daily oral dose to healthy, uninfected subjects for 10 days. The Company anticipates testing the antiviral potency of PA-457 in HIV-infected individuals later this year.
On June 2, 2004, Panacos Pharmaceuticals entered into a definitive merger agreement with V.I. Technologies, Inc. (Nasdaq: VITX), a biotechnology company dedicated to developing novel anti-infective technologies. The transaction is expected to close in the third quarter of 2004 and is subject to the approval by shareholders of both companies and other customary closing conditions.
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule, orally available drugs for the treatment of HIV and other major human viral diseases. The Company's proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection.
Panacos Pharmaceuticals to Present Phase 1 Data on its Lead HIV-1 Drug Candidate, PA-457, at XV International AIDS Conference, Bangkok, Thailand
Additional presentations to be made on PA-457 and Panacos' HIV fusion inhibitor discovery program
GAITHERSBURG, MD, June 17, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced that it will present the results of a recently completed Phase 1 clinical trial of the first-in-class HIV Maturation Inhibitor, PA-457, at the International AIDS Conference in Bangkok, Thailand on July 14th. PA-457 disrupts HIV maturation, a new target for antiretroviral drug discovery that was recently identified by Panacos scientists. As a result of its novel mechanism of action, PA-457 retains activity against virus isolates resistant to the currently approved classes of HIV therapeutics including reverse transcriptase inhibitors and protease inhibitors. The increasing prevalence of these drug resistant HIV strains is a major problem for the treatment of HIV infection, driving the demand for the development of novel drugs like PA-457.
In a single, escalating dose Phase 1 study in uninfected, healthy volunteers, PA-457 was well tolerated and exhibited favorable oral bioavailability and pharmacokinetics that support once daily oral administration. Detailed results will be provided by Dr. David E. Martin, Panacos' Vice President, Drug Development, in a presentation titled: "The In Vitro and In Vivo Disposition of PA-457, a Novel Inhibitor of HIV-1 Maturation" (Presentation #WePeA5644). The presentation will also include data from pre-clinical studies, which suggest that PA-457 should not be subject to drug-drug interactions when used in combination therapy with approved HIV drugs.
Panacos will make two additional presentations on PA-457 at the Conference. The first of these describes recent studies that help elucidate PA-457's antiviral target. The drug candidate specifically blocks a late step in processing of the viral Gag protein, namely conversion of the capsid precursor to mature capsid protein. Following PA-457 treatment, virus particles released from HIV-infected cells are non-infectious and virus replication is terminated. The Panacos presentation provides new data on specific amino acids in Gag that are implicated in PA-457's activity (Presentation #WeOrA1276; July 14). A third presentation on PA-457 describes how the drug potently inhibits HIV replication both in vitro and in an animal model of HIV infection (Presentation #WePeA5643; July 14).
Panacos will also present data on its fusion inhibitor program, describing the Company's recent success in identifying several novel small molecule inhibitors of HIV fusion to human cells. Orally bioavailable small molecule fusion inhibitors would offer considerable potential for the treatment of HIV infection, including viral strains resistant to currently approved drugs. Based on its proprietary high-throughput assay system for identification of small molecule fusion inhibitors, Panacos believes it has a leading position in the discovery of such compounds. The presentation will be made by Dr. Carl Wild, Panacos' Chief Science Officer (Presentation #WePeA5650; July 14).
On June 2, 2004, Panacos Pharmaceuticals entered into a definitive merger agreement with V.I. Technologies, Inc. (Nasdaq: VITX), a biotechnology company dedicated to developing novel anti-infective technologies. The transaction is expected to close in the third quarter of 2004 and is subject to the approval by shareholders of both companies and other customary closing conditions.
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule, orally available drugs for the treatment of HIV and other major human viral diseases. The Company's proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection.
|
|
| |
| |
|
|
|
