Chimerix Initiates Phase 3 SUPPRESS Trial of Brincidofovir (CMX001) for Prevention of CMV in HCT Recipients

Chimerix Initiates Phase 3 SUPPRESS Trial of Brincidofovir (CMX001) for Prevention of CMV in HCT Recipients

 
DURHAM, N.C., Sept. 9, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced initiation of dosing in the Phase 3 SUPPRESS trial (ClinicalTrials.gov ID: NCT01769170). SUPPRESS is evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection, the most significant infectious disease in hematopoietic cell transplant (HCT) recipients. Brincidofovir is an investigational oral nucleotide analog lipid-conjugate that has demonstrated activity against all pathogenic double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses, and polyomaviruses.

Chimerix Announces Top Line Data From CMX001 Phase 2 Adenovirus Study and Late-Breaker Presentation at ICAAC

 
-Encouraging results from the first proof-of-concept study for adenovirus infection support continued clinical development of CMX001 as a first-in-class broad-spectrum antiviral for prevention of double-stranded DNA viral infections

-Data accepted for oral late-breaker presentation at the ICAAC Annual Meeting on September 10th

DURHAM, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced top line data from the exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus (AdV) infection, the first interventional trial in AdV infection. In this trial in allogeneic hematopoietic cell transplant (HCT) recipients, the 100 mg dose given twice weekly (BIW) demonstrated decreased levels of AdV viremia and showed a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given once weekly (QW). Planned intent-to-treat analyses as well as exploratory analyses in specific patient groups were consistent in trends favoring the CMX001 BIW regimen over placebo, although statistical significance was not established in this exploratory study.

Chimerix CEO: Public market is critical to financing biotech R&D

 
July 15, 2013
Chimerix (Nasdaq: CMRX) CEO Ken Moch is speaking out about the role of the public market in financing research and development.

Moch, whose company hit the public market earlier this year, recently spoke at a hearing held by the House Financial Services’ Subcommittee on Capital Markets and Government Sponsored Enterprises.

Chimerix stock pops 34% after IPO at $14 per share

 

DURHAM, N.C., April 12, 2013 — Chimerix's debut as a public company produced a whopping climb in stock price.

The Durham company went public at $14 per share, raising $102 million for the antivirals company.

But Chimerix’s public debut proved to be even stronger and the stock marched upward throughout the day topping the $18 per share mark in afternoon trading. Chimerix (Nasdaq: CMRX) closed its first day of trading at $18.79 per share, up 34 percent from its offering price.

The closing price was the high for the day. Some 4.5 million shares were traded.

Chimerix sold 7.3 million shares, which is some 20 percent more than the 6.1 million shares that the company had originally planned to sell. Morgan Stanley and Cowen and Company are joint book-running managers for the offering. William Blair and Lazard Capital Markets are co-managers.

Chimerix can raise even more money. Underwriters have 30 days to purchase up to an additional 1 million shares of common stock to cover over-allotments, if any. The offering is expected to close on April 16.

Chimerix Appoints Michelle Berrey Chief Medical Officer

RESEARCH TRIANGLE PARK, NC, November 12, 2012 — Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that Michelle Berrey, MD, MPH, has joined the company as Chief Medical Officer.

"We are delighted to have Michelle join our leadership team. Dr. Berrey is a seasoned drug developer who has established a strong track record in antivirals, in particular with nucleotide analogs. She joins Chimerix at an important time for the company as our lead compound, CMX001, advances into Phase 3 clinical testing,” said Kenneth I. Moch, Chimerix President and Chief Executive Officer. “Her extensive background in antiviral drug development will be invaluable to our already strong team.”

Transplant antiviral strong in phase 2; Chimerix plans phase 3 start this year

 
February 6, 2012

North Carolina biotechnology company Chimerix reported positive phase 2 results for a broad spectrum antiviral agent expected to have applications fighting infections faced by bone marrow transplant patients.

Chimerix now plans to start phase 3 clinical trials on CMX001 later this year. The company is studying the compound for the prevention of cytomegalovirus diseases, or CMV, in patients who have had hematopoietic stem cell transplants. Durham, North Carolina-based Chimerix said that compared to a placebo, CMX001 had a statistically significant benefit in preventing CMV from entering the bloodstream or from causing CMV disease 13 weeks after a transplant. The data were presented at a blood and marrow transplant conference in San Diego last Friday.

CMV is a member of the herpesvirus group of viruses; like other herpesviruses CMV has the ability to remain dormant in the body for long periods of time. The virus can lead to serious disease and even death in transplant recipients, cancer patients and others who have compromised immune systems.

Chimerix Announces Presentation of Final Data from CMX001 Phase 2 Trial in Prophylaxis of Cytomegalovirus in Hematopoietic Stem Cell Transplant Recipients

Abstract Receives "BEST ABSTRACTS AWARD FOR CLINICAL RESEARCH" at 2012 BMT Tandem Meetings on February 3rd, 2012

RESEARCH TRIANGLE PARK, NC, January 25, 2012 – Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced that final data from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV), has been accepted for oral presentation at the BMT Tandem Meetings on February 1-5, 2012, in San Diego, California.  CMX001 is a broad spectrum, Lipid-Antiviral-Conjugate completing Phase 2 clinical development for the prevention of CMV in hematopoietic cell transplant (HCT) recipients.  In total, three abstracts related to CMX001 have been accepted for presentation at the 2012 BMT Tandem Meetings, the combined annual meetings of the Center for International Blood and Marrow Transplant Research (CIBMTR) and the American Society of Blood and Marrow Transplantation (ASBMT)....

Chimerix Announces Late-Breaker Presentation At 51st Interscience Conference On Antimicrobial Agents And Chemotherapy (ICAAC) Annual Meeting

DURHAM, N.C., Sept. 16, 2011 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced today that investigators will present preliminary data for CMX001 in a late-breaker presentation at the 51st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Chicago – September 17-20).

Chimerix Completes $45 Million Financing to Fund Further Development of Novel Antiviral Therapeutics CMX001 and CMX157

 

Financing Reflects Significant Clinical Progress and Positive Data in Lead Programs

RESEARCH TRIANGLE PARK, NC, February 14, 2011 – Chimerix, Inc., a pharmaceutical company developing orally- available broad spectrum antiviral therapeutics, today announced the completion of a $45 million Series F financing. New Leaf Venture Partners led the round, with participation by new investors Pappas Ventures and Morningside Group, as well as existing investors Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.