HOPKINTON, Mass., May 14 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. today reports operational and financial results for the quarter ended March 31, 2008 and provides further information for fiscal year 2008. Recent highlights include:
- Encouraging 12 month interim results from the Phase I/IIa Cethrin(R) clinical trial in acute spinal cord injury - Entry into an option agreement which provides the Company with an option to amend its Cethrin license to lower milestone payments and royalty rates in exchange for a fee - Expansion of sites for the first stage of the Parkinson's or Essential Tremor, or POET-2, Altropane(R) Phase III clinical trial program - $5 million raised in March 2008
"Our programs continue to show promising progress," said Peter G. Savas, Chairman and Chief Executive Officer of Alseres. "We are encouraged by the unprecedented sensory and motor recovery seen in patients treated with Cethrin in our Phase I/IIa clinical trial. Key opinion leaders with whom we have spoken are highly impressed by the efficacy findings in the study. Armed with these results and after discussions with regulatory authorities and expert advisors, we were able to reduce the planned size of our Phase IIb clinical trial from 200 patients to a maximum of 100 patients providing us with potential time savings and cost reductions."
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"We plan to start this trial in acute cervical spinal cord injury patients in the second half of this year," Savas noted. "Our recent agreement to improve the terms of the Cethrin license may represent a major step forward for Alseres in realizing the full value of our Cethrin spinal cord program and our Rho inhibitor technology platform and may open up key partnering opportunities."
Recent Corporate Highlights - The 12 month interim results from the Phase I/IIa Cethrin clinical trial in acute spinal cord injury show promising neurological recovery in severely injured acute cervical spinal cord injury patients treated with Cethrin. The trial enrolled a total of 48 patients of which 37 have reached the full 12 month follow up evaluation. The data for these first 37 patients indicate that at 6 and 12 months after treatment, 38% (5/13) of cervical injury patients showed marked recovery of motor and sensory function after treatment as measured by a 2-grade or better improvement in the American Spinal Injury Association, or ASIA, Impairment Scale. Subgroup analysis of ASIA grade by dose group indicate that Cethrin doses of 1 and 3 mg appear to be the most beneficial for cervical patients with 43% (3 of 7) showing the same 2-grade or better recovery of motor and sensory function. In addition, one cervical patient in each of the 1 and 3 mg dose groups showed a 3-grade improvement to AIS D. - We entered into an option agreement whereby the Company can exercise its option to amend certain terms of the Cethrin license with BioAxone Therapeutic, Inc. in exchange for a fee of $7 million. If Alseres exercises this option, the pre-commercial milestone payments in the amended license agreement will be reduced from $25 million to $7 million payable on or before December 31, 2009. In addition, the sales-based royalties in the amended license agreement will be reduced from 10-12% to 4% for spinal cord injury and 1% for all other indications. Finally, the amended license agreement will eliminate all development milestones. - In April 2008, Alseres announced the expansion in the number of sites now open for enrollment in the first stage of the Altropane POET-2 Phase III clinical trial program. The sites participating in the first stage of the POET-2 clinical trial program are: 1) University of Alabama, Birmingham, AL, Principal Investigator: Ray Watts, M.D.; 2) University of Arizona Medical Center, Tucson, AZ, Principal Investigator: Scott Sherman, M.D.; 3) Cedars-Sinai Medical Center, Los Angeles, CA, Principal Investigator: Alan Waxman, M.D.; 4) University of Florida McKnight Brain Institute, Gainesville, FL, Principal Investigator: Ramon Rodriguez, M.D.; 5) Dartmouth-Hitchcock Medical Center, Lebanon, NH, Principal Investigator: David Coffey, M.D.; 6) University of Texas Houston Medical School, Houston, TX, Principal Investigator: Mya Schiess, M.D.; 7) University of Texas Southwestern Medical Center, Dallas, TX, Principal Investigator: Padraig O'Suilleabhain, M.D. - On March 18, 2008, the Company entered into a Third Amended and Restated Convertible Promissory Note Purchase Agreement among Robert L. Gipson, Thomas Gipson, Arthur Koenig, Ingalls & Snyder Value Partners, L.P. and Highbridge International LLC (each a "Purchaser"). The agreement provides for the Company to borrow, in addition to the $25 million already borrowed from the Purchasers, $5 million from Robert L. Gipson, an existing Purchaser. The agreement further provides that the Company may borrow up to an additional $5 million from any Purchaser on the terms and conditions in the agreement. All other terms of the agreement remained the same. Financial Highlights of the First Quarter 2008 - Cash, cash equivalents and marketable securities at March 31, 2008 totaled $4.9 million as compared to $4.2 million at December 31, 2007. Convertible notes payable totaled $28.1 million at March 31, 2008 as compared to $23.3 million at December 31, 2007. - Net loss attributable to common stockholders was $5.3 million, or $0.26 per share, for the first quarter of 2008, as compared to $4.1 million, or $0.25 per share, in the first quarter of 2007. - Research and development (R&D) expenses totaled $2.7 million in the first quarter of 2008 as compared to $2.6 million in the first quarter of 2007. The increase in R&D expenses was primarily due to higher headcount and Cethrin clinical costs offset by lower costs in our molecular imaging program. - General and administrative (G&A) expenses totaled $2.2 million for the first quarter of 2008 as compared to $1.6 million in the first quarter of 2007. The increase in G&A expenses was primarily related to higher headcount, higher patent and related costs and higher commercialization and communication costs. Alseres Pharmaceuticals Upcoming Milestones - We intend to move forward with our previously announced plans for the Cethrin Phase IIb trial in acute spinal cord injury in the second half of 2008. The Company is currently identifying appropriate sites and investigators for the study. The trial will be a double-blind, randomized, placebo-controlled, multi-center, Phase IIb trial in up to 100 subjects with acute cervical SCI conducted at up to 80 sites in the United States, Canada, Europe and other selected countries. - We will continue enrollment in the first part of the POET-2 Phase III clinical trial for Altropane molecular imaging agent. The trial calls for enrollment of up to 80 subjects to generate an image training set. These images will be used to train the expert readers in the study, as is customary for clinical trials of molecular imaging agents. - We are pursuing development and commercialization partnerships for our molecular imaging, nerve repair and regenerative therapy assets. We expect to continue confidential discussions with franchise leaders interested in our molecular imaging and regenerative therapeutic pipelines. We expect discussions to advance materially toward partnerships over the course of this year. Conference Call Access Information
The company will host a conference call to discuss results on, May 15, 2008, at 9:00 a.m. Eastern Daylight Time. To access the conference call, please dial 877-795-3649 for domestic and 719-325-4817 international. The code for this conference call is 1073493. Please dial in 5 to 10 minutes prior to the scheduled start time. A replay of the call will be posted on the Investor Relations section of our website, http://www.alseres.com/, within 48 hours following the conference call and will be available through Thursday, May 29th, 2008.
About Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of therapeutic and diagnostic products primarily for disorders in the central nervous system (CNS). The Company maintains a world-class intellectual property position in the field of regenerative therapeutics. The Company's energy and focus is reflected in several important initiatives. Cethrin, a recombinant-protein-based drug designed to promote nerve repair after acute spinal cord injury, demonstrated positive interim results in a Phase I/IIa clinical trial. The Company's research and pre-clinical programs include, Inosine for the treatment of spinal cord injury and stroke, Oncomodulin for the treatment of ocular injury and disease and research programs directed at a number of regenerative therapies including bone repair. The Company has a robust molecular imaging development program targeting diagnosis of Parkinson's disease and potentially dementia. The Company's lead molecular imaging product candidate is Altropane which is in Phase III clinical trials for the diagnosis of Parkinsonian Syndromes including Parkinson's Disease. The Company has research collaborations with Harvard Medical School and Children's Hospital Boston.
Forward-Looking Statements
The foregoing release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding Alseres' future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including the development and commercialization of Altropane and Cethrin, the prospects of the Company's CNS and regenerative therapeutics programs, the Company's strategies to develop and commercialize axon regeneration technologies and the breadth of the Company's technologies and intellectual property portfolio. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the Company's Annual Report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Alseres from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Alseres is providing the information in this press release as of this date and assumes no obligations to update the information in this press release.
Alseres is a trademark and Cethrin and Altropane are registered trademarks of Alseres Pharmaceuticals, Inc.
Contact:
Sharon Correia - 508-497-2360 ext. 224
Alseres Pharmaceuticals, Inc.
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